|
Report Date : |
10.09.2013 |
IDENTIFICATION DETAILS
|
Name : |
AMNEAL PHARMACEUTICALS COMPANY ( |
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Registered
Office : |
882/1-871, Village Rajoda, Near Hotel Kankavati, Bavla, Ahmedabad – 382 220, |
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Country : |
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Financials (as
on) : |
31.03.2012 |
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Date of
Incorporation : |
07.04.2006 |
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Com. Reg. No.: |
04-048109 |
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Capital
Investment / Paid-up Capital : |
Rs.712.348 Millions |
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|
|
|
CIN No.: [Company Identification
No.] |
U24231GJ2006PTC048109 |
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|
TAN No.: [Tax Deduction &
Collection Account No.] |
AHMA06911C |
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PAN No.: [Permanent Account No.] |
AAGCA0781K |
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Legal Form : |
Private Limited Liability Company |
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Line of Business
: |
Subject is engaged in scientific research activities, including due
diligence analytical testing for Abbreviated New Drug Application (ANDA) and
marketing of research work and resulting products. |
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|
|
|
No. of Employees
: |
Information denied by the management. |
RATING & COMMENTS
|
MIRA’s Rating : |
B (35) |
|
RATING |
STATUS |
PROPOSED CREDIT LINE |
|
|
26-40 |
B |
Capability to overcome financial difficulties seems comparatively
below average. |
Small |
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Maximum Credit Limit : |
USD 2921000 |
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Status : |
Moderate |
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Payment Behaviour : |
Slow but correct |
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Litigation : |
Clear |
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Comments : |
Subject is an established company having a moderate track record. The company has been successful in wiping-off its accumulated losses
of the previous year. Reserves of the company appear to be low. Trade relations are reported as fair. Business is active. Payments are
reported to be slow but correct. The company can be considered for business dealings with some caution.
|
NOTES :
Any query related to this report can be made
on e-mail : infodept@mirainform.com
while quoting report number, name and date.
ECGC Country Risk Classification List – March 31st, 2013
|
Country Name |
Previous Rating (31.12.2012) |
Current Rating (31.03.2013) |
|
India |
A1 |
A1 |
|
Risk Category |
ECGC
Classification |
|
Insignificant |
A1 |
|
Low |
A2 |
|
Moderate |
B1 |
|
High |
B2 |
|
Very
High |
C1 |
|
Restricted |
C2 |
|
Off-credit |
D |
EXTERNAL AGENCY RATING
|
Rating Agency Name |
ICRA |
|
Rating |
Term Loan: BBB- |
|
Rating Explanation |
Moderate degree of safety it carry moderate credit risk. |
|
Date |
September, 2012 |
RBI DEFAULTERS’ LIST STATUS
Subject’s name is not enlisted as a defaulter
in the publicly available RBI Defaulters’ list.
EPF (Employee Provident Fund) DEFAULTERS’ LIST STATUS
Subject’s name is not enlisted as a defaulter
in the publicly available EPF (Employee Provident Fund) Defaulters’ list as of
31-03-2012.
INFORMATION DECLINED
Management non co-operative [91-2714-304700]
LOCATIONS
|
Registered Office/ Research and Development Centre : |
882/1-871, Village Rajoda, Near Hotel Kankavati, Bavla, Ahmedabad – 382 220, |
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Tel. No.: |
91-2714-304700 |
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Fax No. : |
91-2714-304704 |
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E-Mail : |
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Website : |
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Area : |
3000 sq ft |
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Location : |
Owned |
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New York Administrative Offices : |
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Tel. No.: |
631.952.0214 |
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Fax No.: |
631.656.1009 |
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Account Management, Sales Operations and
Customer Response Offices : |
118 Beaver Trail, |
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Tel. No.: |
866.525.7270/ 270.678.9393 |
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Fax No.: |
866.525.7271 |
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E-Mail : |
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Business Development and Corporate Offices : |
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Tel. No.: |
908.947.3120/ 908.947.3122 |
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Fax No.: |
908.947.4146 |
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E-Mail : |
DIRECTORS
AS ON 29.09.2012
|
Name : |
Mr. Suresh Punambhai Patel |
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Designation : |
Whole Time Director |
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|
Address : |
Block No.54, Shri Somnath Nagar CHS Limited, Behind Sanghvi School,
Navrangapura Road, Wadaj, Ahmedabad – 380 013, Gujarat, India |
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Date of Appointment : |
01.10.2011 |
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PAN No.: |
ACRPP4822E |
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DIN No. : |
01856345 |
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Other Directorship :
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Name : |
Mr. Kanubhai Punambhai Patel |
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Designation : |
Director |
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Address : |
22, Ramyakunj Society, Galaxy Cinema, Naroda, Ahmedabad – 382 325,
Gujarat, India |
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Date of Appointment : |
17.11.2007 |
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DIN No. : |
01883090 |
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Other Directorship :
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Name : |
Mr. Chintu Kanubhai Patel |
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Designation : |
Director |
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Address : |
115, Northfield Road., Parsippany, NJ 07054-3187, USA |
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Date of Appointment : |
07.04.2006 |
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DIN No. : |
01980171 |
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Other Directorship :
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Name : |
Mr. Nikunj Bansibhai Patel |
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Designation : |
Whole Time Director |
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|
Address : |
A/29/A, Karmachari Nagar Society, Part-1, Opposite Alkapuri Society,
Ghatlodia, Ahmedabad – 380 061, Gujarat, India |
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Date of Birth/Age : |
04.11.1975 |
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Date of Appointment : |
01.10.2011 |
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PAN No.: |
ALJPP2060M |
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DIN No. : |
02790495 |
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Other Directorship :
|
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KEY EXECUTIVES
|
Name : |
Dr. Ravi Kumar Nithiyanandam |
|
Designation : |
Head Vice President (PR & D) |
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|
|
Name : |
Dr. V.K. Agrawal |
|
Designation : |
Senior Vice President |
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|
Name : |
Santhanakrishnan Srinivasan |
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Designation : |
Director |
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|
Name : |
Mr. Anil Kabra |
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Designation : |
Senior General Manager (Finance) |
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|
Name : |
Ms. Vanita Girdharilal Agrawal |
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Designation : |
Secretary |
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Address : |
14, Laxmi Society, Bed Mandir Road, Kankaria, Ahmedabad – 380 022,
Gujarat, India |
|
Date of Appointment : |
02.02.2012 |
|
PAN No.: |
AIAPA3799C |
MAJOR SHAREHOLDERS / SHAREHOLDING PATTERN
AS ON 31.03.2012
|
Names of Shareholders |
|
No. of Shares |
|
Amneal Pharmaceuticals |
|
57073229 |
|
Amneal Pharma Investment Holding, Mauritius |
|
14011494 |
|
Nikunj Patel |
|
150050 |
|
Suresh Patel |
|
49 |
|
Suresh Patel C/o Rajchandra Medical Corporation, India |
|
1 |
|
Total |
|
71234823 |
AS ON 29.09.2012
|
Equity Share Breakup |
|
Percentage of Holding |
|
Category |
|
|
|
Foreign holdings [Foreign institutional investors, Foreign Companies, Foreign Financial Institutions, Non-resident Indian or Overseas corporate bodies or others] |
|
99.79 |
|
Directors
or relatives of directors |
|
0.21 |
|
Total |
|
100.00 |
BUSINESS DETAILS
|
Line of Business : |
Subject is engaged in scientific research activities, including due
diligence analytical testing for Abbreviated New Drug Application (ANDA) and
marketing of research work and resulting products. |
GENERAL INFORMATION
|
No. of Employees : |
Information denied by the management. |
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|
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Bankers : |
v
Bank of Baroda, S.G. Highway Branch, Shapath-III,
Near GNFC Info Tower, S.G. Highway, Ahmedabad – 380 054, Gujarat, India v Bank of Baroda, Bank of Baroda Towers, 3rd
Floor, Opposite Law Garden, Ellisbridge,
Ahmedabad - 380 006, Gujarat, India |
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|
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Facilities : |
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|
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Banking
Relations : |
- |
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Auditors : |
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|
Name : |
S.R. Batliboi and Associates Chartered Accountants |
|
Address : |
2nd Floor, Shivalik, IshaanAhmedabad, Gujarat, India |
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PAN No. : |
AABFS3421N |
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|
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Holding Company : |
Amneal Pharmaceuticals LLC, USA |
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Fellow Subsidiary Company : |
Amneal Pharma
Investment Holdings, Mauritius |
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|
|
|
Enterprises which are owned, or have significant
influence of or are partners with Key management personnel and their
relatives : |
|
CAPITAL STRUCTURE
AS ON 31.03.2012
Authorised Capital :
|
No. of Shares |
Type |
Value |
Amount |
|
75000000 |
Equity Shares |
Rs.10/- each |
Rs.750.000 Millions |
|
|
|
|
|
Issued, Subscribed & Paid-up Capital :
|
No. of Shares |
Type |
Value |
Amount |
|
71234823 |
Equity Shares |
Rs.10/- each |
Rs.712.348 Millions |
|
|
|
|
|
FINANCIAL DATA
[all figures are
in Rupees Millions]
ABRIDGED BALANCE
SHEET
|
SOURCES OF FUNDS |
|
31.03.2012 |
31.03.2011 |
|
I.
EQUITY
AND LIABILITIES |
|
|
|
|
(1)
Shareholders' Funds |
|
|
|
|
(a) Share Capital |
|
712.348 |
572.233 |
|
(b) Reserves & Surplus |
|
17.791 |
(3.910) |
|
(c) Money
received against share warrants |
|
0.000 |
0.000 |
|
|
|
|
|
|
(2)
Share Application money pending allotment |
|
0.000 |
0.000 |
|
Total
Shareholders’ Funds (1) + (2) |
|
730.139 |
568.323 |
|
|
|
|
|
|
(3) Non-Current
Liabilities |
|
|
|
|
(a) Long-term borrowings |
|
399.496 |
143.068 |
|
(b) Deferred tax liabilities (Net) |
|
4.759 |
5.815 |
|
(c) Other long term
liabilities |
|
0.000 |
0.000 |
|
(d) Long-term
provisions |
|
3.533 |
1.604 |
|
Total Non-current
Liabilities (3) |
|
407.788 |
150.487 |
|
|
|
|
|
|
(4) Current Liabilities |
|
|
|
|
(a) Short
term borrowings |
|
0.000 |
0.000 |
|
(b) Trade
payables |
|
3.421 |
1.185 |
|
(c) Other
current liabilities |
|
143.801
|
107.506
|
|
(d) Short-term
provisions |
|
8.140 |
9.418 |
|
Total Current
Liabilities (4) |
|
155.362 |
118.109 |
|
|
|
|
|
|
TOTAL |
|
1293.289 |
836.919 |
|
|
|
|
|
|
II.
ASSETS |
|
|
|
|
(1) Non-current assets |
|
|
|
|
(a) Fixed Assets |
|
|
|
|
(i)
Tangible assets |
|
360.366 |
355.945 |
|
(ii)
Intangible Assets |
|
1.943 |
0.611 |
|
(iii)
Capital work-in-progress |
|
445.875 |
95.999 |
|
(iv)
Intangible assets under development |
|
0.000 |
0.000 |
|
(b) Non-current Investments |
|
0.000 |
0.000 |
|
(c) Deferred tax assets (net) |
|
0.000 |
0.000 |
|
(d) Long-term Loan and Advances |
|
56.656 |
70.923 |
|
(e) Other
Non-current assets |
|
7.502 |
0.515 |
|
Total Non-Current
Assets |
|
872.342 |
523.993 |
|
|
|
|
|
|
(2) Current assets |
|
|
|
|
(a)
Current investments |
|
81.502 |
0.000 |
|
(b)
Inventories |
|
67.813
|
45.922
|
|
(c) Trade
receivables |
|
121.179
|
0.000
|
|
(d) Cash
and cash equivalents |
|
125.074
|
41.202
|
|
(e)
Short-term loans and advances |
|
23.877 |
219.653 |
|
(f) Other
current assets |
|
1.502 |
6.149 |
|
Total
Current Assets |
|
420.947 |
312.926 |
|
|
|
|
|
|
TOTAL |
|
1293.289 |
836.919 |
|
SOURCES OF FUNDS |
|
|
31.03.2010 |
|
|
SHAREHOLDERS FUNDS |
|
|
|
|
|
1] Share Capital |
|
|
415.324 |
|
|
2] Share Application Money |
|
|
0.000 |
|
|
3] Reserves & Surplus |
|
|
0.000 |
|
|
4] (Accumulated Losses) |
|
|
(22.103) |
|
|
NETWORTH |
|
|
393.221 |
|
|
LOAN FUNDS |
|
|
|
|
|
1] Secured Loans |
|
|
127.580 |
|
|
2] Unsecured Loans |
|
|
1.778 |
|
|
TOTAL BORROWING |
|
|
129.358 |
|
|
DEFERRED TAX LIABILITIES |
|
|
3.745 |
|
|
|
|
|
|
|
|
TOTAL |
|
|
526.324 |
|
|
|
|
|
|
|
|
APPLICATION OF FUNDS |
|
|
|
|
|
|
|
|
|
|
|
FIXED ASSETS [Net Block] |
|
|
327.102 |
|
|
Capital work-in-progress |
|
|
7.149 |
|
|
|
|
|
|
|
|
INVESTMENT |
|
|
0.000 |
|
|
DEFERRED TAX ASSETS |
|
|
0.000 |
|
|
|
|
|
|
|
|
CURRENT ASSETS, LOANS & ADVANCES |
|
|
|
|
|
|
Inventories |
|
|
17.354
|
|
|
Sundry Debtors |
|
|
0.000
|
|
|
Cash & Bank Balances |
|
|
4.792
|
|
|
Other Current Assets |
|
|
6.647
|
|
|
Loans & Advances |
|
|
253.658
|
|
Total
Current Assets |
|
|
282.451
|
|
|
Less : CURRENT
LIABILITIES & PROVISIONS |
|
|
|
|
|
|
Sundry Creditors |
|
|
29.005 |
|
|
Other Current Liabilities |
|
|
60.002
|
|
|
Provisions |
|
|
1.371
|
|
Total
Current Liabilities |
|
|
90.378
|
|
|
Net Current Assets |
|
|
192.073
|
|
|
|
|
|
|
|
|
MISCELLANEOUS EXPENSES |
|
|
0.000 |
|
|
|
|
|
|
|
|
TOTAL |
|
|
526.324 |
|
PROFIT & LOSS
ACCOUNT
|
|
PARTICULARS |
31.03.2012 |
31.03.2011 |
31.03.2010 |
|
|
|
SALES |
|
|
|
|
|
|
|
Income |
408.890 |
256.021 |
118.886 |
|
|
|
Other Income |
6.755 |
1.215 |
13.908 |
|
|
|
TOTAL (A) |
415.645 |
257.236 |
132.794 |
|
|
|
|
|
|
|
|
Less |
EXPENSES |
|
|
|
|
|
|
|
Personnel Expenses |
382.090 |
229.474 |
33.515 |
|
|
|
Operating and Administrative Expenses |
|
|
47.948 |
|
|
|
Exceptional items |
|
|
26.229 |
|
|
|
Prop period items |
|
|
0.000 |
|
|
|
TOTAL (B) |
382.090 (including
financial & depreciation) |
229.474 (including
financial & depreciation) |
107.692 |
|
|
|
|
|
|
|
|
Less |
PROFIT/
(LOSS) BEFORE INTEREST, TAX, DEPRECIATION AND AMORTISATION (A-B) (C) |
|
|
25.102 |
|
|
|
|
|
|
|
|
|
Less |
FINANCIAL
EXPENSES (D) |
|
|
17.202 |
|
|
|
|
|
|
|
|
|
|
PROFIT/
(LOSS) BEFORE TAX, DEPRECIATION AND AMORTISATION (C-D) (E) |
|
|
7.900 |
|
|
|
|
|
|
|
|
|
Less/ Add |
DEPRECIATION/
AMORTISATION (F) |
|
|
21.677 |
|
|
|
|
|
|
|
|
|
|
PROFIT/ (LOSS)
BEFORE TAX (E-F) (G) |
33.555 |
27.762 |
(13.777) |
|
|
|
|
|
|
|
|
|
Less |
TAX (H) |
11.854 |
9.570 |
1.626 |
|
|
|
|
|
|
|
|
|
|
PROFIT/ (LOSS)
AFTER TAX (G-H) (I) |
21.701 |
18.192 |
(15.403) |
|
|
|
|
|
|
|
|
|
Add |
PREVIOUS YEARS’
BALANCE BROUGHT FORWARD |
NA |
(22.102) |
(6.699) |
|
|
|
|
|
|
|
|
|
|
BALANCE
CARRIED TO THE B/S |
NA |
NA |
(22.102) |
|
|
|
|
|
|
|
|
|
|
EARNINGS IN
FOREIGN CURRENCY |
|
|
|
|
|
|
|
Rendering of contract research and development services |
NA |
256.021 |
118.886 |
|
|
TOTAL EARNINGS |
NA |
256.021 |
118.886 |
|
|
|
|
|
|
|
|
|
|
IMPORTS |
|
|
|
|
|
|
|
Capital Goods |
29.908 |
39.212 |
16.674 |
|
|
|
Raw Materials |
2.347 |
0.749 |
|
|
|
|
Consumables |
0.462 |
0.139 |
|
|
|
TOTAL IMPORTS |
32.717 |
40.100 |
16.674 |
|
|
|
|
|
|
|
|
|
|
Earnings/ (Loss)
Per Share (Rs.) |
0.37 |
0.40 |
(0.69) |
|
KEY RATIOS
|
PARTICULARS |
|
31.03.2012 |
31.03.2011 |
31.03.2010 |
|
PAT / Total Income |
(%) |
5.22
|
7.07 |
(11.60)
|
|
|
|
|
|
|
|
Net Profit Margin (PBT/Sales) |
(%) |
8.21
|
10.84 |
(11.59)
|
|
|
|
|
|
|
|
Return on Total Assets (PBT/Total Assets} |
(%) |
3.96
|
3.75 |
(2.26)
|
|
|
|
|
|
|
|
Return on Investment (ROI) (PBT/Networth) |
|
0.05
|
0.05 |
(0.04)
|
|
|
|
|
|
|
|
Debt Equity Ratio (Total Debt/Networth) |
|
0.55
|
0.25 |
0.33
|
|
|
|
|
|
|
|
Current Ratio (Current Asset/Current Liability) |
|
2.71
|
2.65 |
3.13
|
LOCAL AGENCY FURTHER INFORMATION
|
Sr. No. |
Check List by
Info Agents |
Available in
Report (Yes / No) |
|
1] |
Year of Establishment |
Yes |
|
2] |
Locality of the firm |
Yes |
|
3] |
Constitutions of the firm |
Yes |
|
4] |
Premises details |
Yes |
|
5] |
Type of Business |
Yes |
|
6] |
Line of Business |
Yes |
|
7] |
Promoter's background |
Yes |
|
8] |
No. of employees |
No |
|
9] |
Name of person contacted |
No |
|
10] |
Designation of contact person |
No |
|
11] |
Turnover of firm for last three years |
Yes |
|
12] |
Profitability for last three years |
Yes |
|
13] |
Reasons for variation <> 20% |
-- |
|
14] |
Estimation for coming financial year |
No |
|
15] |
Capital in the business |
Yes |
|
16] |
Details of sister concerns |
Yes |
|
17] |
Major suppliers |
No |
|
18] |
Major customers |
No |
|
19] |
Payments terms |
No |
|
20] |
Export / Import details (if applicable) |
No |
|
21] |
Market information |
-- |
|
22] |
Litigations that the firm / promoter involved in |
-- |
|
23] |
Banking Details |
Yes |
|
24] |
Banking facility details |
Yes |
|
25] |
Conduct of the banking account |
-- |
|
26] |
Buyer visit details |
-- |
|
27] |
Financials, if provided |
Yes |
|
28] |
Incorporation details, if applicable |
Yes |
|
29] |
Last accounts filed at ROC |
Yes |
|
30] |
Major Shareholders, if available |
Yes |
|
31] |
PAN of Proprietor/Partner/Director, if available |
No |
|
32] |
Date
of Birth of Proprietor/Partner/Director, if available |
Yes |
|
33] |
Voter ID No of Proprietor/Partner/Director, if available |
No |
|
34] |
External Agency Rating, if available |
Yes |
INDEX OF CHARGES:
|
S.
No. |
Charge
ID |
Date
of Charge Creation/Modification |
Charge
amount secured |
Charge
Holder |
Address |
Service
Request Number (SRN) |
|
1 |
10396254 |
11/12/2012 |
798,923.00 |
BANK
OF BARODA |
S G
HIGHWAY BRANCH, SHAPATH III, NEAR G N F C INFO TOWER, BODAKDEV, AHMEDABAD - 380054,
GUJARAT, INDIA |
B65625618 |
|
2 |
10363286 |
18/06/2012 |
834,600.00 |
BANK
OF BARODA |
S G
HIGHWAY BRANCH, SHAPATH III, NEAR G N F C INFO TOWER, BODAKDEV, AHMEDABAD -
380054, GUJARAT, INDIA |
B42743666 |
|
3 |
10345560 |
02/03/2012 |
1,523,430.00 |
BANK
OF BARODA |
S G
HIGHWAY BRANCH, SHAPATH III, NEAR G N F C INFO TOWER, BODAKDEV, AHMEDABAD -
380054, GUJARAT, INDIA |
B36284578 |
|
4 |
10335600 |
30/01/2012 |
1,433,700.00 |
BANK
OF BARODA |
S G HIGHWAY
BRANCH, SHAPATH III, NEAR G N F C INFO TOWER, BODAKDEV, AHMEDABAD - 380054,
GUJARAT, INDIA |
B32144024 |
|
5 |
10300873 |
06/07/2011 |
660,000.00 |
BANK
OF BARODA |
S G
HIGHWAY BRANCH, SHAPATH III, NEAR G N F C INFO TOWER, BODAKDEV, AHMEDABAD -
380054, GUJARAT, INDIA |
B18303438 |
|
6 |
10275616 |
31/01/2011 |
2,093,000.00 |
BANK
OF BARODA |
S G
HIGHWAY BRANCH, SHAPATH III, NEAR G N F C INFO TOWER, BODAKDEV, AHMEDABAD - 380054,
GUJARAT, INDIA |
B08482879 |
|
7 |
10188007 |
30/10/2009 |
1,257,000.00 |
BANK
OF BARODA |
S G
HIGHWAY BRANCH, SHAPATH III, NEAR G N F C INFO TOWER, BODAKDEV, AHMEDABAD -
380054, GUJARAT, INDIA |
A74051624 |
|
8 |
10098200 |
18/06/2013
* |
450,800,000.00 |
BANK
OF BARODA |
S G
HIGHWAY BRANCH, SHAPATH III, NEAR G N F C INFO TOWER, BODAKDEV, AHMEDABAD -
380054, GUJARAT, INDIA |
B79484663 |
|
* Date of charge modification |
||||||
|
Unsecured Loans |
31.03.2012 (Rs.
in Millions) |
31.03.2011 (Rs.
in Millions) |
|
LONG-TERM BORROWINGS |
|
|
|
Foreign currency term loans from others |
127.900 |
0.000 |
|
TOTAL
|
127.900 |
0.000 |
NOTE:
The registered office of the company has been shifted from 9, Indus Park Society,
Opposite Sundervan, Near Spipa, Ahmedabad,
CORPORATE INFORMATION:
The company,
domiciled in India and incorporated under the provisions of the Companies Act, 1956
is engaged in scientific research activities, including due diligence
analytical testing for Abbreviated New Drug Application (ANDA) and marketing of
research work and resulting products, if any, mainly for exports to its parent
company, Amneal Pharmaceuticals LLC, USA.
PERFORMANCE REVIEW:
During the year
the company has further strengthened its’ business and its Sales of Services of
the Company at Rs.408.890 millions.
SHARE CAPITAL:
During the year authorized Capital is increased to Rs.750.000 millions
and the paid up capital of the company has been increased to Rs.712.348
millions.
FIXED ASSETS:
v
v Buildings
v Plant and Machinery
v Furniture and Fixtures
v Vehicles
v Office Equipment
v Computer
v
Electrical Equipments and Fitting
v Computer Software
PRESS RELEASES:
AMNEAL
PHARMACEUTICALS ANNOUNCES FIVE NEW ORAL SOLIDS
POTASSIUM CHLORIDE EXTENDED-RELEASE CAPSULES
AND SILDENAFIL CITRATE, NEVIRAPINE, METAXALONE, AND WARFARIN SODIUM IN TABLET
FORM FURTHER EXPAND GENERICS PORTFOLIO
BRIDGEWATER, NJ
(USA), AUGUST 2, 2013
Following the highly-anticipated Q1 launch of its generic equivalent to Suboxone®, Amneal Pharmaceuticals has brought five additional products to market. These medications represent over $550 million of market value across multiple therapeutic categories and demonstrate the generic manufacturer’s continued commitment to deliver affordable medicines across a wide range of treatment areas. This rapid succession of new product launches is testament to Amneal’s extraordinary growth.
Potassium chloride extended-release capsules are available in 10 mEq K (750 mg) strength in 100, 500 and 1000-count. Amneal’s generic is AB-rated and therapeutically equivalent to the RLD for Micro-K®10 ExtenCaps® (registered trademarks of Nesher Pharmaceuticals (USA) LLC).
Sildenafil tablets are available in 20 mg strength in 90-count. The Amneal generic is AB-rated and therapeutically equivalent to Revatio® (a registered trademark of Pfizer Inc.).
Nevirapine tablets, USP, are available in 200 mg strength in 60-count. Amneal’s generic is AB-rated and therapeutically equivalent to Viramune® (a registered trademark of Boehringer Ingelheim Pharmaceuticals, Inc.).
Metaxalone tablets are available in 800 mg strength in 100-count. The Amneal generic is AB-rated and therapeutically equivalent to Skelaxin® (a registered trademark of King Pharmaceuticals Research and Development, Inc.).
Warfarin sodium tablets are available in 1, 2, 2.5, 3, 4, 5,
6, 7.5, and 10 mg strengths in 100-count. Amneal’s generic is AB-rated and
therapeutically equivalent to Coumadin® (a
registered trademark of Bristol-Myers Squibb Pharma Company). Warfarin sodium is a boxed warning drug. Please
see full prescribing information below.
All five products are now shipping and available through wholesalers, distributors, and directly to the trade.
Amneal Pharmaceuticals, LLC is a U.S.-based manufacturer of
generic pharmaceuticals. Known as “Generic’s New Generation”, Amneal prides
itself on its unwavering commitment to quality, meaningful business
relationships, and innovative approach to maximizing value for all
stakeholders. Extensive investment in R&D, an intelligently aggressive expansion
strategy, and focus on vertical integration are key contributors to the
company’s impressive growth over the past several years. Amneal is
headquartered in Bridgewater, New Jersey with manufacturing, R and D,
packaging, sales and distribution facilities throughout the U.S., as well as
abroad.
AMNEAL
PHARMACEUTICALS RECEIVES FDA APPROVAL FOR GENERIC SUBOXONE®
BUPRENORPHINE
HCL AND NALOXONE HCL TABLETS FOR TREATING OPIOID ADDICTION EXPECTED TO SAVE
MILLIONS IN HEALTHCARE COSTS
BRIDGEWATER, NJ (USA), FEBRUARY 25, 2013
Amneal Pharmaceuticals, LLC, the 7th largest generic drug manufacturer in the U.S. market, has received U.S. FDA approval for one of the first generic versions of Suboxone® sublingual tablets for maintenance treatment of opioid drug dependence. Generic buprenorphine hydrochloride (HCl) and naloxone HCl dihydrate sublingual tablets are now available in 2 mg/0.5 mg and 8 mg/2 mg strengths, both in 30-count bottles. The Amneal medication is bioequivalent to Suboxone® (a registered trademark of Reckitt Benckiser Healthcare (UK) Limited (RB.L)). Annual U.S. sales of Suboxone® in all dosage forms are $1.5 billion, according to December 2012 IMS Health market data.
Providing opioid-dependent patients with high quality generic buprenorphine HCl and naloxone HCl through treatment in physicians’ offices, treatment centers, or prescriptions filled at retail pharmacies offers tremendous cost savings for both consumers and the U.S. healthcare system, while delivering the same therapeutic effect as the brand medication. To help their patients take advantage of this lower cost alternative, physicians should clearly indicate “buprenorphine HCl and naloxone HCl tablets” or “Suboxone® tablets” when writing prescriptions to avoid confusion at the pharmacy. Patients currently using any form of Suboxone® should ask their doctors or dispensing pharmacists for buprenorphine HCl and naloxone HCl sublingual tablets to get the cost-saving generic version with a pleasant orange flavor.
In addition to patients and their prescribing physicians, a more cost-effective opioid addiction treatment should be welcome news to insurance companies, the Centers for Medicare and Medicaid Services, the Veterans Health Administration and other payors, pharmacy benefits managers (PBMs), managed care facilities, drug addiction and recovery organizations and treatment advocacy groups as well. Generic drugs are saving the U.S. healthcare system one billion dollars every other day, according to the Generic Pharmaceutical Association.
“The FDA’s decision to approve the first generic equivalents to Suboxone® sublingual tablets will ensure that millions of patients in the U.S. who need this product now have access to a high quality, low cost generic version,” said Chirag Patel, President and Co-Chairman of Amneal. “Since the agency has issued its opinion on Reckitt Benckiser’s September 2012 Citizen’s Petition in favor of generic competition, Amneal’s buprenorphine HCl and naloxone HCl tablets can offer consumers and physicians greater choice in opioid addiction treatment. We are also pleased that the FDA has referred this matter to the Federal Trade Commission to investigate and address Reckitt’s anticompetitive business practices.”
“We appreciate the FDA’s thorough assessment of Reckitt’s Citizen’s Petition and applaud their recent decision to deny it in its entirety,” said Chintu Patel, Amneal CEO and Co-Chairman. “The FDA determined that Reckitt’s petition did not raise valid scientific or regulatory issues associated with the product, which Amneal contended in its comments on the petition. Physicians should have no concerns in writing prescriptions for the generic tablet form of the product.”
Manufactured in Amneal’s fully FDA-compliant Brookhaven, NY facility, buprenorphine HCl and naloxone HCl tablets will be available through wholesalers and distributors as well as directly to the trade. The product received FDA approval under an approved Risk Evaluation and Mitigation Strategy (REMS), known as the Buprenorphine-containing Transmucosal products for Opioid Dependence (BTOD) REMS program, and will be distributed in accordance with FDA and U.S. Drug Enforcement Administration (DEA) regulations governing the handling of CIII controlled substances. The generic tablets will be available to patients when the BTOD REMS program becomes operational in early March.
Amneal Pharmaceuticals, LLC is a U.S.-based manufacturer of generic pharmaceuticals. Known as “Generic’s New Generation,” Amneal prides itself on its unwavering commitment to quality, meaningful business relationships, and innovative approach to maximizing value for all stakeholders. Extensive investment in R and D, an intelligently aggressive expansion strategy, and focus on vertical integration are key contributors to the company’s impressive growth over the past several years. Amneal is headquartered in Bridgewater, New Jersey with manufacturing, R and D, packaging, sales and distribution facilities throughout the U.S., as well as abroad.
CMT REPORT (Corruption, Money Laundering & Terrorism]
The Public Notice information has been collected from various sources
including but not limited to: The Courts,
1] INFORMATION ON
DESIGNATED PARTY
No 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 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.65.96 |
|
|
1 |
Rs.102.91 |
|
Euro |
1 |
Rs.86.58 |
INFORMATION DETAILS
|
Information
Gathered by : |
NYA |
|
|
|
|
Report Prepared
by : |
TPT |
SCORE & RATING EXPLANATIONS
|
SCORE FACTORS |
RANGE |
POINTS |
|
HISTORY |
1~10 |
4 |
|
PAID-UP CAPITAL |
1~10 |
5 |
|
OPERATING SCALE |
1~10 |
3 |
|
FINANCIAL CONDITION |
|
|
|
--BUSINESS SCALE |
1~10 |
5 |
|
--PROFITABILIRY |
1~10 |
4 |
|
--LIQUIDITY |
1~10 |
4 |
|
--LEVERAGE |
1~10 |
4 |
|
--RESERVES |
1~10 |
3 |
|
--CREDIT LINES |
1~10 |
3 |
|
--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 |
NO |
|
--AFFILIATION |
YES/NO |
YES |
|
--LISTED |
YES/NO |
NO |
|
--OTHER MERIT FACTORS |
YES/NO |
YES |
|
--RBI |
YES/NO |
NO |
|
--EPF |
YES/NO |
NO |
|
TOTAL |
|
35 |
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 |
Capability to overcome financial difficulties seems comparatively
below average. |
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 |
|
- |
NB |
New Business |
- |
This report is issued at your request without any
risk and responsibility on the part of MIRA INFORM PRIVATE LIMITED (MIPL)
or its officials.