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Report
Date : |
30th
May 2006 |
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Name : |
KLENZAIDS CONTAMINATION CONTROLS PRIVATE LIMITED |
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Registered
Office : |
A-21-22, MIDC Industrial Area, Street No. 3, Andheri
(East), Mumbai-400093, Maharashtra, India |
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Country
: |
India |
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Financials
(as on) : |
31.03.2005 |
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Date
of Incorporation : |
1st February, 1978 |
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Com.
Reg. No.: |
11-20112 |
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CIN
No.: [Company
Identification No.] |
U33112MH1978PTC020112 |
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IEC
No.: |
0388050594 |
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Legal
Form : |
Private Limited Liability Company |
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Line
of Business : |
Manufacturer of and Dealer in Clean Room Equipments and
Accessories, Surgical Equipments and Facilities for parenterals including
L.V.P., Ophthalmic ointments, surgical suits, patient houses ad other
equipments for turn-key sterile facilities, laminar flow work stations,
tailor made, to suit individual application, needs, air showers, air barriers
for insect contract, in line modules and laminar air flow. |
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MIRA’s
Rating : |
A |
RATING |
STATUS |
PROPOSED CREDIT LINE |
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56-70 |
A |
Financial
& operational base are regarded healthy. General unfavourable factors
will not cause fatal effect. Satisfactory capability for payment of interest
and principal sums |
Fairly Large |
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Maximum
Credit Limit : |
USD
175000 |
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Status
: |
Good |
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Payment
Behaviour : |
Regular |
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Litigation
: |
Clear |
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Comments
: |
Subject is a well – established and reputed concern having
fine track records. Financial position is good. Trade relations are fair.
Payments are correct and as per commitments. The concern can be considered good for normal business
dealings at usual trade terms and conditions. |
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Registered
Office : |
A-21-22, MIDC Industrial Area, Street No. 3, Andheri
(East), Mumbai-400093, Maharashtra, India |
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Tel.
No.: |
91-22-28218921 (10 lines) |
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Fax
No.: |
91-22-28377837/927 |
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E-Mail
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Website:
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Area : |
11000 sq. fts. - Leased |
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Corporate
Office: |
New # 13, Old # E-159A, VII Avenue, Besant Nagar, Chennai
– 600090, India |
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Tel
No. : |
91-44-24467863/4 |
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Email
: |
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Factory
1 : |
219, GIDC
Industrial Area, Umergaon District – Valsad
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Tel.
No.: |
91-260-2562082 |
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Fax
No.: |
91-260-2563082 |
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Email
: |
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Area : |
30000 Sq.
ft - Leased |
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Location : |
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Factory
2 : |
1/1, ˝,
3/1, GIDC Industrial Area, District – Valsad |
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Tel.
No.: |
91-260-2562862 |
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Area : |
2000 Sq.
ft - Leased |
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Location : |
Leased |
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Name : |
Mr. Prabhakar V. Shetty |
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Designation
: |
Director |
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Address
: |
Plot No. 1, 4D, 1st Floor, R.D. Muljee Nagar,
S.V. Road, Borivali (West), Mumbai-400092, Maharashtra, India |
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Date
of Appointment : |
1st May, 2003 |
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Name : |
Mr. Krishnamurthy H. |
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Designation
: |
Director |
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Address
: |
D – 7, Eavour, Goft Road |
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Date
of Birth : |
8th September, 1953 |
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Qualification
: |
B. Com, ACA |
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Experience
: |
28 Years |
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Date
of Appointment : |
1st December, 1983 |
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Name : |
Mrs. Neena Y. Mathur |
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Designation
: |
Director |
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Address
: |
Mumbai-400026, Maharashtra, India |
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Date
of Appointment : |
30th November, 1985 |
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Date
of Leasing : |
30th November, 1990 |
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Name : |
Mr. C. R. Shah |
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Designation
: |
Director |
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Address
: |
Prayag C 15, Ayojananagar, New Sharda Mandir Road,
Ahmedabad-380007, Gujarat, India |
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Date
of Appointment : |
5th March, 1992 |
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Name : |
Mr. Hariprasad K. Iyer |
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Designation
: |
Director |
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Address
: |
14, Suphala Apartment, Bailbazar Road, Gandhi Nagar,
Kalyan (West), Thane-421301 |
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Date
of Appointment : |
19th June, 1992s |
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Name : |
Mr. Chandra M Sahani |
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Designation
: |
Director |
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Address
: |
28, Silver Sadan, Juhu Tara Road, Mumbai – 49 |
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Date
of Birth : |
70 Years |
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Qualification
: |
B. E. |
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Experience
: |
46 Years |
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Name : |
Mr. Himesh C Sahani |
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Designation
: |
Director |
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Address
: |
28, Silver Sadan, Juhu Tara Road, Mumbai – 49 |
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Date
of Birth : |
38 Years |
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Qualification
: |
B. E. |
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Experience
: |
15 Years |
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Name : |
Mr. Ramesh P Lala |
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Designation
: |
Director |
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Address
: |
2, Oiha Niwas, 5 Sector, Juhu Tara Road, Mumbai – 49 |
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Date
of Birth : |
54 Years |
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Qualification
: |
B. Tech |
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Experience
: |
30 Years |
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Names of Shareholders |
No. of Shares |
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Mona C
Sahani |
2251 |
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Manish C
Sahani |
4918 |
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Mr. H P
Sahani |
4980 |
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Mr. H. C.
Shahani |
4920 |
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M/s.
Hamish Inv. Private Limited |
12150 |
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Otimfm |
56 |
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Line
of Business : |
Manufacturer, exporters and dealer in clean room
equipments and accessories, surgical equipments and facilities for
parenterals including L.V.P., ophthalmic ointments, surgical suits, patient
houses ad other equipments for turn-key sterile facilities, laminar flow work
stations, tailor made, to suit individual application, needs, air showers,
air barriers for insect contract, in line modules and laminar air flow. |
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Products
: |
Clean Room Equipments and Pharmaceutical Machineries,
Filter Paper and Machinery Components |
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Exports
to : |
Germany, Developing Countries |
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Imports
from : |
Italy, France and Germany |
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Terms
: |
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Selling : |
Cash & Credit (30 days) |
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Purchasing : |
Cash & credit (60 to 90 days) |
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Particulars |
Unit |
Actual
Production |
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Clean Tech
Machineries |
Sq
mtrs |
819 |
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Pharmaceuticals
Machineries |
- |
7 |
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Accessories |
-- |
107 |
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Customers
: |
End Users |
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No. of
Employees : |
Total 134 :- in office 30 + in factory 100 + in branch 4 |
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Bankers
: |
v Canara Bank, Mumbai v Indusind Bank Limited, Andheri
(East), Mumbai |
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Facilities : |
- |
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Banking Relations : |
Good |
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Auditors
: |
Natwarlal Vepari and Company Chartered Accountant |
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Tel.
No.: |
91-22-22073936/56315851 |
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Fax.
No.: |
91-22-56315852 |
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Address: |
Jiji House, 4th Floor, 15, Ravehine St., Fort,
Mumbai 400001, India |
Authorised
Capital :
|
No. of
Shares |
Type |
Value |
Amount |
|
30000 |
Equity Shares |
Rs. 100 each |
Rs. 3.000 millions |
Issued,
Subscribed & Paid-up Capital :
|
No. of
Shares |
Type |
Value |
Amount |
|
24800 |
Equity Shares |
Rs.
100 each |
Rs.
2.480 millions |
FINANCIAL DATA
[all figures are in Rupees Millions]
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SOURCES OF FUNDS |
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31.03.2005 |
31.03.2004 |
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SHAREHOLDERS
FUNDS |
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1] Share
Capital |
|
2.480 |
2.480 |
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2] Share
Application Money |
|
0.000 |
0.000 |
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3]
Reserves & Surplus |
|
43.358 |
39.518 |
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4]
(Accumulated Losses) |
|
0.000 |
0.000 |
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NETWORTH
|
|
45.838 |
41.998 |
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LOAN
FUNDS |
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1]
Secured Loans |
|
0.037 |
0.037 |
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2]
Unsecured Loans |
|
0.095 |
0.388 |
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TOTAL
BORROWING
|
|
0.132 |
0.425 |
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DEFERRED
TAX LIABILITIES |
|
0.437 |
0.506 |
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TOTAL
|
|
46.407 |
42.929 |
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APPLICATION OF FUNDS
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FIXED ASSETS [Net Block]
|
|
4.338 |
4.727 |
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Capital work-in-progress
|
|
0.000 |
0.000 |
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INVESTMENT
|
|
0.000 |
0.000 |
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DEFERREX TAX ASSETS
|
|
0.000 |
0.000 |
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CURRENT ASSETS, LOANS & ADVANCES
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Inventories
|
|
11.800 |
66.674 |
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Sundry Debtors
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|
12.583 |
14.207 |
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Cash & Bank Balances
|
|
6.818 |
15.186 |
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Other Current Assets
|
|
13.762 |
13.761 |
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Loans & Advances
|
|
85.672 |
94.318 |
Total Current Assets
|
|
130.635 |
204.146 |
|
Less : CURRENT LIABILITIES & PROVISIONS
|
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Current Liabilities
|
|
79.312 |
158.990 |
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Provisions
|
|
9.254 |
6.954 |
Total Current Liabilities
|
|
88.566 |
165.944 |
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Net
Current Assets
|
|
42.069 |
38.202 |
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MISCELLANEOUS EXPENSES
|
|
0.000 |
0.000 |
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|
|
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TOTAL
|
|
46.407 |
42.929 |
|
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PARTICULARS |
|
31.03.2005 |
31.03.2004 |
Sales Turnover [including other income]
|
|
135.246 |
78.537 |
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Profit/(Loss) Before Tax
|
|
6.086 |
1.410 |
Provision for Taxation
|
|
2.232 |
1.144 |
Profit/(Loss) After Tax
|
|
3.854 |
0.266 |
|
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|
|
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|
Export Value |
|
6.262 |
71.857 |
|
|
|
|
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|
Import Value |
|
3.016 |
29.408 |
|
|
|
|
|
|
Total Expenditure |
|
129.159 |
77.127 |
KEY RATIOS
|
PARTICULARS |
|
|
31.03.2005 |
31.03.2004 |
|
PAT / Total Income |
(%) |
|
2.84 |
0.33 |
|
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|
Net Profit Margin (PBT/Sales) |
(%) |
|
4.49 |
1.79 |
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|
Return on Total Assets (PBT/Total Assets} |
(%) |
|
4.50 |
0.67 |
|
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|
Return on Investment (ROI) (PBT/Networth) |
|
|
0.13 |
0.02 |
|
|
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|
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|
Debt Equity Ratio (Total Liability/Networth) |
|
|
1.93 |
3.96 |
|
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|
|
|
|
|
Current Ratio (Current Asset/Current Liability) |
|
|
1.47 |
1.23 |
The companies fixed assets
of important value includes-
Factory Building,
Staff Quarters, Motor Car, Plant and Machinery, Furniture and Fixtures,
Computers, and Office Equipments.
Subject exports pharma machineries and projects.
Subject imports filter paper and machinery components
The company is in trade terms with :
Klenzaids Estabished in 1970 and is a household name in the pharma industry.
AS PER
WEBSITE
ABOUT US
Klenzaids Contamination Controls
Today Klenzaids due to its relentless efforts and
sustained investments in technology is recognized as world's pioneer in
MicroFlora Management and Contamination Control of enclosed spaces. Dedication
to that niche has made us major players in diverse industrial sectors
like Pharmaceuticals, Hospitals, Biolabs, Aerospace, Electronics.
Eliminating
Contamination is our DNA.
Klenzaids has
also been working in the field of Aseptic Technologies providing engineering
services that minimize and control contamination from vectors like Biota,
Personnel, Process, Room Shell, Material and Clean-down.
Klenzaids has
broken through the barrier from Contamination Control to Total Containment
making advances in Barrier Technologies.
Over 35
years - quality is our brand equity, reinforced by our day-to-day working with
ISO - we are periodically audited by TUV and are proud to be
an ISO 9001 : 2000 certified Company.
LA NOTE
EXACTEMENT
MANDATE
Klenzaids
Contamination Controls
To pioneer new
particulate immobilizing technologies in nanometer regime.
Make fair &
equitable profit.
Provide sharpest
cutting-edge creative solutions.
Carry on constant
research.
To satisfy our
customers so completely that they want to work with us as individuals and as a
Company because they are convinced that in us they have found the best
partners.
Upgrade equipment
and facilities.
To be responsible
to our employees.
Experiment with
new ideas and develop innovative programmes and products.
Respect their
dignity and recognize their merit.
To be committed to
the environment we live in. Keep it pristine clean and ever green.
Give equal
opportunity for development and advancement.
We abide to our
Quality Policy.
To provide
competent, just and ethical management.
GMP ACADEMY
In no other industry is Quality as parametrically defined as
in the pharmaceutical industry. Regulations, Standards, limits-constrict
manufacturing latitudes.
In response to the regulatory compliance needs of industry,
the Klenzaids GMP Academy was instituted.
The aim of the Academy is to promote an understanding of
cGMP at fundamental levels, while divesting them of their coercive connotation.
Through multi-pronged efforts (publications, colloquiums,
learning modules and residential focus workshops) the Academy aims to create an
informed Health-Care Industry, capable of initiating proactive responses to
quality related issues.
Gene Technology has gained momentum. It has to demonstrate
higher levels of quality consciousness than mainstream medicine manufacture. To
make that happen, preliminary guidelines have already been drafted. The Klenzaids GMP Academy
will extend its efforts to make cGMP integral to Biotechnology Derived
Products.
Microbiological Evaluation
Aseptic Processing Areas
Micro Monograph # 01
Pharma-industry in USA and EU have objected to the
Regulatory Agencies insistence on particle-counts to establish CLEANLINESS of
aseptic processing areas.
Microbial monitoring is only one limb of information needed
to build a meaningful environmental surveillance and control program. There has
been much discussion as to whether the standards should include numbers. i.e.
limits or levels. At present there exists no scientific rationale or standard
methodologies upon which to base such quantification. Each manufacturer should
be responsible for establishing its own microbial levels based on historical
data, individual facility operations and specific product considerations.
Bacterial De-contamination
Stainless Steel Equipment
Micro Monograph # 02
Stainless Steel is among the most
widely used materials in pharmaceutical equipment construction. The amount of
Stainless Steel utilized in this field has been increasing steadily. A major
problem in the use of stainless steel is the efficient removal of bacterial
cells. Bacterial adhesion and colonization on stainless steel is well known,
but as yet unclear phenomenon in the pharmaceutical industry. In this micro
monograph, general mechanisms of bacterial adhesion to stainless steel, and disinfection
of contaminated surfaces are described.
Pharmaceutical
Facilities:
Integrated Planning
&Construction
Micro Monograph # 03
Most
pharmaceutical projects lack integrated approaches. Although work places are
increasingly becoming networked, the effects are additive, parallel and at
times even negative. Generic—ready to use—solutions for pharmaceutical
production buildings do not and cannot exist. User-requirements, with reference
to product qualities and quantities, production-processes and boundary-conditions
can vary greatly. Templates for pharmaceutical plant projects cannot be taken
off-the-shelf.
cGMP advocates the
integrated planning approach to pharmaceutical projects that yield interactive
results. The essence of that approach is making the process determine the space
elements of the facility, enabling high levels of flexibility, rather than
cumbersome infrastructure dictating how processes should be run.
HVAC Systems Validation
Micro Monograph # 04
VAC systems are an integral component of a
pharmaceutical facility's functionality and impacts on the safety of scientists
and technicians working in a lab or production facility, the integrity of
processes, and the environment outside. An important element of successful HVAC
validation is prevalidation design work. In this micro-monograph, we explore
the correlation between preliminary design and each phase of validation.
Crossflow Filteration
Micro Monograph # 05
Crossflow
filtration is often the primary process used for purification of biotechnology
derived products. Crossflow filtration is distinguished from conventional
"dead-end" filtration, in that the fluid to be filtered, flows
perpendicular to the filtrate stream, rather than parallel to the filtrate or
permeate stream. The concept of concentration polarization is examined as it
affects filter performance, retentivity and flux.
Air Filteration
Micro Monograph # 06
Efficiency, airflow Resistance and
Arrestance capability are primary criteria that differentiate diverse types of
extended surface aerosol filters. Measurable performance— meeting application
needs— is complicated by the many Standards defining panel filter
classifications which do provide means for comparing and ranking filters, but
do not provide adequate information needed by filtration system designers who
have to meet specific requirements; and, who also want to minimize system costs
and energy use .
This micro-monograph correlates the
unified EURO Standard EN 779, to the American Standards ; and, reviews them
historically. It also distinguishes EN 1822, which covers the DIN Schwebstoff —
HEPA and ULPA — range from the IEST Institute of Environmental Science
Technology Recommended Practice 001 to 008.
Bioanalytical Method Validation
Micro Monograph #
07
This micro-monograph represents the
US Food and Drug Administration's current thinking on this topic. An
alternative approach may be used if such approach satisfies the requirements of
the applicable statutes and regulations. The intent is to provide assistance to
sponsors of investigational new drug applications —INDs — new drug applications
— NDAs — abbreviated new drug applications — ANDAs — and supplements in
developing bioanalytical method validation information used in human clinical
pharmacology, bioavailability — BA — and bioequivalence — BE — studies
requiring pharmacokinetic — PK — evaluation. This guidance also applies to
bioanalytical methods used for non-human pharmacology and toxicology studies
and preclinical studies. For studies related to the veterinary drug approval
process, this guidance applies only to blood and urine BA, BE, and PK studies.
P-4 Biocontainment Facilities
Micro Monograph # 08
In aseptic and clean and hypobaric
containment facilities, the envelope and environment control directly affect
egress reliability. Safety and effectiveness cannot be tested or inspected into
such a facility as an afterthought.
The modular approach is
contra-indicated. In a true modular system; walls; ceilings; return air chases;
utility access chases; and even the heating; ventilating ; and air-conditioning
system — HVAC — are standardized components with clearly defined functions.
Hazop Management
Micro Monograph # 09
The meaning of hazard is often
confused with risk. Hazard is defined as the inherent potential of a substance
and activity to harm people or the environment. Hazard does not have a
probability component.
Hazop Analysis is a qualitative
tool amongst a sub-group that is covered by this narrative. Defining
quantitative elements that are pre-requisites for Hazop qualification of
Klenzaids Isolators are also presented.
Vaporized Hydrogen Peroxide
Micro Monograph # 10
As simple as it may seem, the
treatment of contaminated elements is as diverse and complicated as the
operations from which it comes. In today's environment, where merely
transferring contaminants from one medium to another is no longer acceptable,
it is no surprise that a powerful oxidizer that looks like water — in its
appearance, chemical formula and reaction products — should be so widely used.
This is hydrogen peroxide — H2O2 — a powerful yet versatile oxidant that is
both safe and effective.
Instrument Calibration & Certification
Micro Monograph # 11
It is generally presumed that most
instruments used in the pharma industry, in both formulation and bulk sectors,
function as intended. That perception alone is not enough.
Proof of performance by way of
calibration and certification is GMP-mandated. That proof is derived from
reference measurements and calibration. The precision with which these results
of measurements are simulated, must be documented and witnessed by the
end-user; and, finally certified in accordance with International Standards;
the more important ones being traceable to ANSI — American National Standards
Institute — and ISO Guide 25 and 58.
The documentation of processes for
the calibration of instruments, making up the analytical and production
equipment, is vital to the Quality Systems that spell out compliance to cGMP. A
series on instrument calibration and certification is being brought to you in
this micro-monograph.
The factors to be considered in
instrument selection within the context of calibration and certification are
described.
Particulate Cleanliness Evaluation
Micro Monograph # 12
Importance of non-viable airborne
particles is introduced in this micro-monograph. This monograph intends to deal
with the measurement and analysis of particles in parenterals as they relate to
regulatory conformance. Particle Counters are, therefore, described here in
some detail.
Cleaning Validation
Mini Monograph # 01
A significant portion of this Monograph is
derived from round-table discussions on Cleaning Validation held during various
validation courses conducted by the PDA. The summary is organized around the
following series of questions:
What is being cleaned ?
When must cleaning validation be performed?
Which physical parameters must be evaluated?
How clean is clean? And many more!
cGMP Validation of Aseptic
Pharmaceutical Facilities
Mini Monograph # 02
Since cGMP validation is a
framework designed to establish total control over process outcome, the
documentation needed to provide evidence that this has been achieved will vary
with the specific program. Depending on how and when the data is generated and
utilized, validation is said to be prospective, retrospective or concurrent.
Documentary requirements for prospective and retrospective validation — as
currently employed internationally in aseptic pharmaceutical production — are
described in this mini-monograph. By definition, process validation requires
the accumulation of documentary evidence that a specific process will
constantly produce a product meeting its predetermined specifications and
quality characteristics. Unfortunately, there is still much confusion as to
what constitutes process validation documentation.
Water in the Pharmaceutical Industry
Mini Monograph # 03
Water is a singular substance
possessing unusual properties that renders it extraordinarily useful as a drug
vehicle. Water is used in the Pharmaceutical Industry for Process and for
Energies. In this presentation the current processes used in the production of
pharmaceutical waters, are evaluated, regulatory limits operational for various
categories are presented and present technological trends that are becoming
current GMP in the production processes are described.
Pharmaceutical
Clean Air Systems
Mini Monograph # 04
Clean Air Systems
are an integral aspect of every pharmaceutical facility. In this mini-monograph
the focus is on mechanisms of air filtration and filtration qualification. The
first part describes deposition and adsorption mechanisms of particulate and
vapor contaminants.
Freeze Drying of Sterile Products
Mini Monograph # 05
In this mini-monograph, we discuss
the basic principles of lyophilization along with guidelines for process
validation and sterilization. This freeze dry process is commonly referred to
as lyophilization from (Greek made solvent loving). Lyophilization is a means
of drying, achieved by freezing the wet substance and causing the ice to
sublime directly to vapour by exposing it to a low partial pressure of water
vapor. At these low pressures, water in the form of ice, can be turned directly
into water vapor without first becoming liquid, by adding heat energy.
cGMP for Pharma Premises
and Materials
Mini Monograph # 06
A decision to develop, manufacture,
and or market a medical device requires a basic understanding of the
responsibility of the Food and Drug Administration. In particular, individuals
who are responsible for the manufacture of devices, whether as part of a
production or quality control function, must recognize their potential exposure.
This section is intended to describe basic provisions. The general operation of
the Food and Drug Administration as it relates to the manufacture of devices;
and the development and current status of FDA regulations on device good
manufacturing practices.
Moist Heat Sterilization : Current
Principles and Practices
Technical Monograph
Efforts of personnel in many
disciplines, familiar with all aspects of the process from inception, are
involved in the development of an efficacious Moist Heat Sterilization Process
and its execution. The process is susceptible to a wide range of variables. The
advent of new heat-sensitive solutions, as well as more sophisticated
container-closure systems and materials, require a constant redefinition in the
approach to moist heat sterilization. Process parameters must be established
for every end-product container system that is developed.
This technical Monograph provides a
cogent overview of the current principles and practices in moist heat
sterilization.
Sterilization and Depyrogenation using Dry Heat
Technical Monograph
Dry Heat
Sterilization is the preferred method for treatment of heat stable materials
that will not tolerate steam. A significant advantage of dry heat processing is
the destruction of bacterial endotoxins that have a much greater heat
resistance than bacterial spores.
In this Monograph, the current
status of sterilization and depyrogenation using dry heat are examined, and
readers are familiarised with the basic microbiological, statistical and
engineering concepts that are essential for effective development of the
process.
Since depyrogenation is a field
characterised by rapid technological advances, an attempt is made to acquaint
the reader with some of the recent research findings in the area. Kinetics of
endotoxin inactivation have been specially emphasised.
Label Design and Labelling of Drugs
R.S. Iyer & S M Mudda
Designing product labels is an art,
as the label has to reconcile the demands of the law, the medical claims, promotional
efforts and, in an increasingly competitive environ-ment, the demand for
aesthetic appeal.
In this Monograph, an effort has
been made to put together all the legal requirements for designing a drug
label. These are presented in the form of two appendices to this book. The
Appendices form the core of the publication and provide the rationale for it.
Aims
& Objectives
The academy conducts one/two day seminars held across
various cities all over India. It draws créme-de-la-créme faculty from the
industry. Participants come from various disciplines, like QA/QC, Production,
Research at all levels and that makes the colloquiums highly interactive and
interesting.
Glimpse
of held Colloquiums :
• SOPs, Designed for Doing
• Parenteral Problems
• Documentation Blues
• Labels & Good Labelling Practice more than a legal
requirement
• Sterile Product Manufacture
(Entry level induction programme)
• Scientific Storekeeping • Primary
Packaging
• Taming Tableting (A focus workshop)
• Tablet Coating from obscure art
to an exacting Science
• Aseptic Processing from
Conception to Compliance
• Sampling Skills
• Focus Workshop on Good Laboratory
Practice
• Cleaning Validation - A current
perspective
• The GMP Route to TQC
• GCP Compliances in Clinical
Trials.
Your
Only Global Source ........
INDIAN FOUNDATION
FOR PHARMACEUTICAL REFERENCE STANDARD SUBSTANCES
The Pharmaceutical Industry always
stands sky high in producing Quality Medicines. IFPRESS is proud to provide
REFERENCE STANDARD SUBSTANCES IP INTEGRAL and Important part of QC, QA and
R&D.
RELIABILITY AND AUTHENTICITY IS
ASSURED by Preparation and Standardization by reputed manufacturers, in
accordance with strict Standard Operating Procedures Tested and Certified by
CDL, Calcutta. Subdivision, Storage and Distribution is by qualified persons
under directions of an expert committee, in a model Class 100 aseptic facility.
IFPRESS (INDIAN FOUNDATION FOR
PHARMACEUTICAL REFERENCE STANDARD SUBSTANCES) is the custodian of the project,
comprising professionals from the Regulatory Agencies, Industry, Academia and
Research Disciplines.
AVAILABLE
. Acetazolamide
. Cloxacillin Sodium
. Mianserin Hydrochloride
. Albendazole
. Clofazimine
. Metoprolol Tartrate
. Amoxycillin Trihydrate
. Danazol
. Mebendazole
. Ampicillin Trihydrate
. Dithranol
. Nandrolone Phenylpropionate
. Ascorbic Acid
. Diphenhydramine Hydrochloride
. Nalidixic Acid
. Betamethasone Valerate 17
. Ethyloestranol
. Nicotinic Acid
. Betamethasone Sodium Phosphate
. Folic Acid
. Nitrofurazone
. Bromhexine Hydrochloride
. Furazolidone
. Norfloxacin
. Cephalexine
. Glibenclamide
. Piroxicam
. Chloroquine Phosphate
. Ibuprofen
. Salbutamol Sulphate
. Chloroquine Sulphate
. Lignocaine Hydrochloride
. Sodium Valproate
. Ciprofloxacin Hydrochloride
. Mefenamic Acid
. Terbutaline Sulphate
. Atenolol
. Dicyclomine Hydrochloride
. Oxytetracycline Dihydrate
. 6-APA*
. Diclofenac Sodium
. PHPA*
. 7-ADC*
. Dicloxacilliin Sodium*
. Procaine Penicillin
. Betamethasone
. Diazepam
. Pentazocine
. Betamethasone Valerate 21
. Doxycycline Hydrochloride
. Penicillin G. Pottasium
. Beclomethasone 17 Propionate
. Ethambutol Hydrochloride
. Ranitidine Hydrochloride
. Benzyl Penicillin Sodium
. Flurbiprofen
. Ranitidine B*
. Cefuroxime Sodium
. Flucloxacillin Sodium*
. Rifampicin
. Cefadroxil
. Metronidazole
. Rifampicin Quinone*
. Chlorpropamide
. Methdilazine Hydrochloride
. Terfenadine
. DCDA*
. Metformin Hydrochloride
. Thyroxine Sodium
. Dicyclomine Hydrochloride
SERVICES
Maintenance
and Validation services for all laminar Flow Work Stations, both supplied by us
as well as supplied by other organizations
Supply and Replacement of all spares needed for the
workstations
Renovation and Up
gradations of Clean Air Systems
Carrying out area
validation to certify cleanliness levels
Consultation
Pharmaceutical Engineering services
Designing of HVAC and Filtration System for Clean Rooms
Area Layouts including support facility in selection of
suitable equipments for the projects
Segregated services for Injectbles and Vaccines
Barrier Isolation Technology
Designing of Barrier isolators & manufacture
Provision of Solutions & Designs for Containment Systems
Complete turn key projects undertaking
Provision of techno-economical services
Provision of solutions for handling dry bulk
pharma-chemicals
Provision of complete know-how of Bio-technological systems
Aseptic processes for requirements in Pharma & Research
Units
GMP
issues & stimulated discussions on design, manufacture, control monitor and
technical audit of pharma systems
Today Klenzaids due
to its relentless efforts and sustained investments in technology is recognized
as world's pioneer in MicroFlora Management and Contamination Control of
enclosed spaces. Dedication to that niche has made us major players in
diverse industrial sectors like Pharmaceuticals, Hospitals, Biolabs, Aerospace,
Electronics
Consequently, we have encountered demands for widening our
service –product program to include sub moronic filtration of other media like
gas and liquids. Besides, it is in production machinery for the Pharma sector
as an application are where we have evolved solutions that have been well
received by the pharma industry. The
demand is such that a committed effort has to be made to fulfill the enormous
needs of the country.
The main trust of Klenzaids is to evolve total capabilities
encompassing systems with concept-planning, drawing-up of specifications,
supply installation and commissioning, after-sales service and validation of
-wide range of equipment, such as
-Rotary And Liner Vial/ Bottle Washer
-On-Line Depyrogenating –Sterilizing – Drying Tunnels For Glass
Vials / Ampoules / Bottles
-On – Line Liquid- Filling Plugging – Sealing Equipment For
Vials /Bottles
-Super heated Water Spray and Steam Sterilizers
-Rubber / Plastic Stopper Washing- Sterilizing-Drying Units
-Class 100 Batch type double-door Dry Heat Sterilizers
- Inspection machines for liquid injectables.
For the last 30 years we have been evolving systems for Bio
Clean Rooms and have successfully executed a large number of projects
Klenzaids has also been working in the field of Aseptic
Technologies with an objective of providing engineering services towards
minimizing and controlling of contamination from vectors like: ambient
environment, personnel, process contamination, bioclean room shell, material
decontamination and cleaning, material handling within the facility.
Klenzaids helps client to establish protocols for bioclean
room operation, housekeeping nad maintenance. Klenzaids also executes
assignments for complete facilities including design, layouts, HVAC, air
filtration system and clean room finished
EQUIPMENT
AND SERVICES
v ENVIRONMENTAL
CONTROL PRODUCTS
v NSF 49
LAMINAR FLOW CLEAN AIR WORK STATIONS
v ANAEROBIC
HOODS
v FILTRATION
MODULE AND ROOM PRESSURIATION SYSTEMS
v PREFILTERS,
HEPA FILTERS, ULPA FILTERS
v GRADED
VELOCITY (GRADVEL) FILTRATION SYSTEM
v AIR SHOWERS
AIR CURTAINS
v API
PROCESSING CHAMBERS AND SIOLATORS, HALF / FULL SUIT SUITES ANIMAL ABODES,
CAGING SYSTEMS, CAGE WASHING AND DOWNDRAFT TABLES BIOCONTAIMENT STATIONS
v ISOLATORS
AND BARRIER CONTROL SYSTEMS, STERILITY TESTING ISOLATORS, ALPHA-BETA PORTS
PHARMA
PROCESS EQUIPMENT
v ROTARY AND
LINERS VIAL / BOTTLE WASHERS
v ON LINE
DEPYROGENATING STERILIZING TUNNELS FOR GLASS VIALS / AMPOULES
v ONLINE
FILLTING PLUGGING SEALING EQUIPMENT
v VIAL/AMPOULE/BOTTLE
INSPECTION MACHINES FOR LIQUIDS/POWDERS
v SPECIATION
MACHINES
v RUBBER
STOPPER WASHING-STERILISING DRYING UNIT
v FILLED
AMPOULES WASHING DRYING TRAY LOADING UNIT
v TURNTABLES,
CONVEYOURS, TRAY LOADERS – OFF LOADERS
v CLASS 100
DRY HEAT STERILIZERS
v STEAM
STERILIZERS / AUTOCLAVES
MICRO
ENVIRONMENT SYSTEMS AND PROJECTS
v COMPLETE
DESIGN ASSIGNMENTS FOR SETTING UP BIO-CLEAN ROOM FACILITIES FOR
PHARMACEUTICALS, ELECTRONICS AND OTHER INDUSTRIAL APPLICATIONS
v TUNKEY JOB
FOR HVAC AND FILTRATION SYSTEMS
v SPECIAL
CLEAN ROOM FINISHES
v VALIDATION
SERVICE FOR CLEAN ROOM ENVIRONMENT
v G. M. P.
DESIGN AND EVALUATION SERVICES
v PROCESS
VALIDATION : DESIGN AND TESTING SERVICES BIOHAZARD / CHEMHAZARD CONTAINMENT
SYSTEMS AND FACILITIES.
KLENZAIDS
GMP ACADEMY
v TECHNICAL
PUBLICATIONS
v DATA
ACUISITION AND DISSEMINATION
v CONTINUATIVE
LEARNING PROGRAMS
v CUSTOMER
GUIDANCE – REGULATORY AFFAIRS
v TECHNOLOGY
TRANSFER
CMT REPORT [Corruption, Money laundering
& Terrorism]
The Public
Notice information has been collected from various sources including but not
limited to: The Courts, India Prisons Service, Interpol, etc.
1] INFORMATION
ON DESIGNATED PARTY
No
records exist designating subject or any of its beneficial owners, controlling
shareholders or senior officers as terrorist or terrorist organization or whom
notice had been received that all financial transactions involving their assets
have been blocked or convicted, found guilty or against whom a judgement or
order had been entered in a proceedings for violating money-laundering,
anti-corruption or bribery or international economic or anti-terrorism sanction
laws or whose assets were seized, blocked, frozen or ordered forfeited for
violation of money laundering or international anti-terrorism laws.
2] Court
Declaration :
No records exist to suggest that subject is or was the
subject of any formal or informal allegations, prosecutions or other official
proceeding for making any prohibited payments or other improper payments to
government officials for engaging in prohibited transactions or with designated
parties.
3] Asset
Declaration :
No
records exist to suggest that the property or assets of the subject are derived
from criminal conduct or a prohibited transaction.
4] Record
on Financial Crime :
Charges or conviction registered
against subject: None
5] Records
on Violation of Anti-Corruption Laws :
Charges or investigation registered
against subject: None
6] Records
on Int’l Anti-Money Laundering Laws/Standards :
Charges or investigation registered
against subject: None
7] Criminal
Records
No
available information exist that suggest that subject or any of its principals
have been formally charged or convicted by a competent governmental authority
for any financial crime or under any formal investigation by a competent
government authority for any violation of anti-corruption laws or international
anti-money laundering laws or standard.
8] Affiliation
with Government :
No record
exists to suggest that any director or indirect owners, controlling
shareholders, director, officer or employee of the company is a government
official or a family member or close business associate of a Government
official.
9] Compensation
Package :
Our market
survey revealed that the amount of compensation sought by the subject is fair
and reasonable and comparable to compensation paid to others for similar
services.
10] Press Report :
No press reports / filings exists on the subject.
CORPORATE GOVERNANCE
MIRA INFORM
as part of its Due Diligence do provide comments on Corporate Governance to
identify management and governance. These factors often have been predictive
and in some cases have created vulnerabilities to credit deterioration.
Our
Governance Assessment focuses principally on the interactions between a
company’s management, its Board of Directors, Shareholders and other financial
stakeholders.
CONTRAVENTION
Subject is
not known to have contravened any existing local laws, regulations or policies
that prohibit, restrict or otherwise affect the terms and conditions that could
be included in the agreement with the subject.
FOREIGN EXCHANGE RATES
|
Currency |
Unit
|
Indian Rupees |
|
US Dollar |
1 |
Rs.46.19 |
|
UK Pound |
1 |
Rs.86.51 |
|
Euro |
1 |
Rs.59.32 |
SCORE & RATING EXPLANATIONS
|
SCORE FACTORS |
RANGE |
POINTS |
|
HISTORY |
1~10 |
7 |
|
PAID-UP
CAPITAL |
1~10 |
7 |
|
OPERATING
SCALE |
1~10 |
7 |
|
FINANCIAL
CONDITION |
|
|
|
--BUSINESS
SCALE |
1~10 |
7 |
|
--PROFITABILIRY |
1~10 |
7 |
|
--LIQUIDITY |
1~10 |
7 |
|
--LEVERAGE |
1~10 |
7 |
|
--RESERVES |
1~10 |
7 |
|
--CREDIT
LINES |
1~10 |
7 |
|
--MARGINS |
-5~5 |
- |
|
DEMERIT
POINTS |
|
|
|
--BANK
CHARGES |
YES/NO |
YES |
|
--LITIGATION |
YES/NO |
NO |
|
--OTHER
ADVERSE INFORMATION |
YES/NO |
NO |
|
MERIT
POINTS |
|
|
|
--SOLE
DISTRIBUTORSHIP |
YES/NO |
NO |
|
--EXPORT
ACTIVITIES |
YES/NO |
YES |
|
--AFFILIATION |
YES/NO |
YES |
|
--LISTED |
YES/NO |
NO |
|
--OTHER
MERIT FACTORS |
YES/NO |
YES |
|
TOTAL |
|
63 |
This
score serves as a reference to assess SC’s credit risk and to set the amount of
credit to be extended. It is calculated from a composite of weighted scores
obtained from each of the major sections of this report. The assessed factors
and their relative weights (as indicated through %) are as follows:
Financial condition (40%) Ownership background (20%) Payment record (10%)
Credit history (10%) Market trend (10%) Operational size
(10%)
RATING EXPLANATIONS
|
RATING |
STATUS |
PROPOSED CREDIT LINE |
|
|
>86 |
Aaa |
Possesses
an extremely sound financial base with the strongest capability for timely
payment of interest and principal sums |
Unlimited |
|
71-85 |
Aa |
Possesses
adequate working capital. No caution needed for credit transaction. It has
above average (strong) capability for payment of interest and principal sums |
Large |
|
56-70 |
A |
Financial
& operational base are regarded healthy. General unfavourable factors
will not cause fatal effect. Satisfactory capability for payment of interest
and principal sums |
Fairly Large |
|
41-55 |
Ba |
Overall
operation is considered normal. Capable to meet normal commitments. |
Satisfactory |
|
26-40 |
B |
Unfavourable
& favourable factors carry similar weight in credit consideration.
Capability to overcome financial difficulties seems comparatively below
average/normal. |
Small |
|
11-25 |
Ca |
Adverse
factors are apparent. Repayment of interest and principal sums in default or
expected to be in default upon maturity |
Limited with full security |
|
<10 |
C |
Absolute
credit risk exists. Caution needed to be exercised |
Credit not recommended |