MIRA INFORM REPORT

 

 

Report Date :

25th May, 2006

 

IDENTIFICATION DETAILS

 

Name :

KLENZAIDS CONTAMINATION CONTROLS PRIVATE LIMITED

 

 

Registered Office :

A-21-22, MIDC Industrial Area, Street No. 3, Andheri (East), Mumbai-400093, Maharashtra, India

 

 

Country :

India

 

 

Financials (as on) :

31.03.2005

 

 

Date of Incorporation :

1st February, 1978

 

 

Com. Reg. No.:

11-20112

 

 

CIN No.:

[Company Identification No.]

U33112MH1978PTC020112

 

 

IEC No.:

0388050594

 

 

Legal Form :

Private Limited Liability Company

 

 

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.

 

RATING & COMMENTS

 

MIRA’s Rating :

A

 

RATING

STATUS

PROPOSED CREDIT LINE

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

 

Maximum Credit Limit :

USD 175000

 

 

Status :

Good

 

 

Payment Behaviour :

Regular

 

 

Litigation :

Clear

 

 

Comments :

Subject is a well – established and reputed concern having fine track. 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.

 

LOCATIONS

 

Registered Office :

A-21-22, MIDC Industrial Area, Street No. 3, Andheri (East), Mumbai-400093, Maharashtra, India

Tel. No.:

91-22-28218921

Fax No.:

91-22-28377837/927

E-Mail :

klenzaidsaseptic@gems.vsnl.net.in

Website:

http://www.klenzaids.com

 

 

Factory 1 :

218, GIDC Industrial Area, Ombergaon, District – Valsad  

Tel. No.:

91-260-2562082

Fax No.:

91-260-2563082

Area :

30000 Sq. ft

Location :

Leased

 

 

Factory 2 :

1/1, ˝, 3/1, GIDC Industrial Area, District – Valsad  

Tel. No.:

91-260-2562862

Area :

2000 Sq. ft

Location :

Leased

 

DIRECTORS

 

Name :

Mr. Prabhakar V. Shetty

Designation :

Director

Address :

Plot No. 1, 4D, 1st Floor, R.D. Muljee Nagar, S.V. Road, Borivali (West), Mumbai-400092, Maharashtra, India

Date of Appointment :

1st May, 2003

 

 

Name :

Mr. Krishnamurthy H.

Designation :

Director

Address :

D – 7, Eavour, Goft Road

Date of Birth :

8th September, 1953

Qualification :

B. Com

Experience :

28 Years

Date of Appointment :

1st December, 1983

 

 

Name :

Mrs. Neena Y. Mathur

Designation :

Director

Address :

Mumbai-400026, Maharashtra, India

Date of Appointment :

30th November, 1985

Date of Leasing :

30th November, 1990

 

 

Name :

Mr. C. R. Shah

Designation :

Director

Address :

Prayag C 15, Ayojananagar, New Sharda Mandir Road, Ahmedabad-380007, Gujarat, India

Date of Appointment :

5th March, 1992

 

 

Name :

Mr. Hariprasad K. Iyer

Designation :

Director

Address :

14, Suphala Apartment, Bailbazar Road, Gandhi Nagar, Kalyan (West), Thane-421301

Date of Appointment :

19th June, 1992s

 

 

Name :

Mr. Chandra M Sahani

Designation :

Director

Address :

28, Silver Sadan, Juhu Tara Road, Mumbai – 49

Date of Birth :

70 Years

Qualification :

B. E.

Experience :

46 Years

 

 

Name :

Mr. Himesh C Sahani

Designation :

Director

Address :

28, Silver Sadan, Juhu Tara Road, Mumbai – 49

Date of Birth :

38 Years

Qualification :

B. E.

Experience :

15 Years

 

 

Name :

Mr. Ramesh P Lala

Designation :

Director

Address :

2, Oiha Niwas, 5 Sector, Juhu Tara Road, Mumbai – 49

Date of Birth :

54 Years

Qualification :

B. Tech

Experience :

30 Years

 

MAJOR SHAREHOLDERS

 

Names of Shareholders

No. of Shares

Mona C Sahani

2251

Manish C Sahani

4918

Mr. H P Sahani

4980

M/s. Hamish Inv. Private Limited

12150

Otimfm

56

 

BUSINESS DETAILS

 

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.

 

 

Products :

Clean Room Equipments and Pharmaceutical Machineries, Filter Paper and Machinery Components

 

 

Exports to :

Germany, Developing Countries

 

 

Imports from :

Italy, France and Germany

 

 

Terms :

 

Selling :

Cash & Credit (30 days)

 

 

Purchasing :

Cash & credit (60 to 90 days)

 

PRODUCTION STATUS

Particulars

Unit

Actual Production

Clean Tech Machineries

Sq mtrs

819

Pharmaceuticals Machineries

-

7

Accessories

--

107

 

 

 

 

 

 

 

 

GENERAL INFORMATION

 

Customers :

End Users

 

 

No. of Employees :

134

 

 

Bankers :

v      Canara Bank, Mumbai

v      Indusind Bank Limited, Andheri (East), Mumbai

 

 

Facilities :

-

 

 

 

Banking Relations :

Good

 

 

Auditors :

Natwarlal Vepari and Company

Chartered Accountant

Tel. No.:

91-22-22073936/56315851

Fax. No.:

91-22-56315852

Address:

Jiji House, 4th Floor, 15, Ravehine St., Fort, Mumbai 400001, India

 

CAPITAL STRUCTURE

 

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]

 

 

ABRIDGED BALANCE SHEET

 

SOURCES OF FUNDS

 

 

31.03.2005

31.03.2004

SHAREHOLDERS FUNDS

 

 

 

1] Share Capital

 

2.480

2.480

2] Share Application Money

 

0.000

0.000

3] Reserves & Surplus

 

43.358

39.518

4] (Accumulated Losses)

 

0.000

0.000

NETWORTH

 

45.838

41.998

LOAN FUNDS

 

 

 

1] Secured Loans

 

0.037

0.037

2] Unsecured Loans

 

0.095

0.388

TOTAL BORROWING

 

0.132

0.425

DEFERRED TAX LIABILITIES

 

0.437

0.506

 

 

 

 

TOTAL

 

46.407

42.929

 

 

 

 

APPLICATION OF FUNDS

 

 

 

 

 

 

 

FIXED ASSETS [Net Block]

 

4.338

4.727

Capital work-in-progress

 

0.000

0.000

 

 

 

 

INVESTMENT

 

0.000

0.000

DEFERREX TAX ASSETS

 

0.000

0.000

 

 

 

 

CURRENT ASSETS, LOANS & ADVANCES

 

 

 

 
Inventories
 

11.800

66.674

 
Sundry Debtors
 

12.583

14.207

 
Cash & Bank Balances
 

6.818

15.186

 
Other Current Assets
 

13.762

13.761

 
Loans & Advances
 

85.672

94.318

Total Current Assets
 

130.635

204.146

Less : CURRENT LIABILITIES & PROVISIONS
 

 

 

 
Current Liabilities
 

79.312

158.990

 
Provisions
 

9.254

6.954

Total Current Liabilities
 

88.566

165.944

Net Current Assets
 

42.069

38.202

 

 

 

 

MISCELLANEOUS EXPENSES

 

0.000

0.000

 

 

 

 

TOTAL

 

46.407

42.929

 

 


PROFIT & LOSS ACCOUNT

 

PARTICULARS

 

 

31.03.2005

31.03.2004

Sales Turnover [including other income]

 

135.246

78.537

 

 

 

 

Profit/(Loss) Before Tax

 

6.086

1.410

Provision for Taxation

 

2.232

1.144

Profit/(Loss) After Tax

 

3.854

0.266

 

 

 

 

Export Value

 

6.262

71.857

 

 

 

 

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

 

 

 

 

 

Net Profit Margin

(PBT/Sales)

(%)

 

4.49

1.79

 

 

 

 

 

Return on Total Assets

(PBT/Total Assets}

(%)

 

4.50

0.67

 

 

 

 

 

Return on Investment (ROI)

(PBT/Networth)

 

 

0.13

0.02

 

 

 

 

 

Debt Equity Ratio

(Total Liability/Networth)

 

 

1.93

3.96

 

 

 

 

 

Current Ratio

(Current Asset/Current Liability)

 

 

1.47

1.23

 

 

LOCAL AGENCY FURTHER INFORMATION

 

The companies fixed assets of important value includes-

 

 Factory Building, Staff Quarters, Motor Car, Plant and Machinery, Furniture and Fixtures, Computers, and Office Equipments.

 

 

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.

 

 

 

INNOVATIONS

Klenzaids Contamination Controls

 

 

 

 

 

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.

 

 

 

 

 

 

 

 

 

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

 


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.45.85

UK Pound

1

Rs.85.68

Euro

1

Rs.58.59

 

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

 

 

 

PRIVATE & CONFIDENTIAL : This information is provided to you at your request, you having employed MIPL for such purpose. You will use the information as aid only in determining the propriety of giving credit and generally as an aid to your business and for no other purpose. You will hold the information in strict confidence, and shall not reveal it or make it known to the subject persons, firms or corporations or to any other. MIPL does not warrant the correctness of the information as you hold it free of any liability whatsoever. You will be liable to and indemnify MIPL for any loss, damage or expense, occasioned by your breach or non observance of any one, or more of these conditions