Pharmaceutical contractmanufacturingwith anobsession forpurity

Liquid injectables

Powder injectables

RELENTLESS PURSUIT OFQUALITY, PURITY ANDSUSTAINABILITY

Micropure has world-class systems and people to ensure products con-tracted to us for manufacture are delivered with absolute certainty that they are pure.

The process from washing, to steriliza-tion and filling is achieved without human contact.

We continually seek ways to maintain and where possible exceed global standards. Today we conform to WHO cGMP & cGLP norms, along with UK MHRA standards.

Employees, the environment and our local community are core to our operations, investment and program for continual improvement.

OPEN LETTER TO OUR CUSTOMERS, PARTNERS AND STAFFAs a qualified and experienced microbiologist, I have held senior engineering and operational positions with large pharmaceutical multinationals. It was during this time that my vision for Micropure was created when I identified the market need for small volume based contract manufacturing, set to the highest possible stan-dards.

Small is important because you can optimise control over quality, purity, safety and efficiency. This in turn allows us to work to the highest standards, satisfy customer requirements and play a quality part in expand-ing global healthcare needs.

Micropure is to be an example for sustainable business, community and environmental practices. Production of worldclass standard pharmaceuticals must work hand-in-hand with ethical practices, local community engagement and minimal impact on the environment.

Thank you for considering our company, and being a part of our obsession for purity in pharmaceuticals.Sincerely yours,

Mrs. Kalpana B Jain (B.Sc. & M.Sc. Microbiology)Managing DirectorMicropure Parenterals Pvt Ltd.

OVERVIEW OF PRODUCTSLiquid Injection available in various strengthsGentamicin Sulphate Inj.Dexamethasone Sodium Phosphate Inj.Amikacin Sulphate Inj.Betamethasone Sodium Phosphate Inj.Chloroquine Phosphate Inj.Chlorpheniramine Maleate Inj.Diazepam Inj.Analgin, Pitofenone Hydrochloride and FenpiveriniumBromide Inj.Frusemide Inj.Diclofenac Sodium Inj.Prednisolone Inj.Piroxicam Inj.Lignocaine Inj.

OTHER PRODUCTS ARE POSSIBLEIf your products are not listed here, and require the

same obsession of purity, please let us know.

Eye/Ear Drops available in various strengths

Betamethasone Eye DropsChloramphenicol Eye Drops

Ciprofloxacin Eye / Ear DropsDexamethasone & Neomycin Eye / Ear Drops

Gentamicin Eye / Ear DropsGentamicin & Dexamethasone Eye / Ear Drops

Norfloxacin Eye / Ear DropsOfloxacin Eye / Ear Drops

Dry Power Injection available in various strengths and combinationsCefotaxime Sodium Inj.Cefotaxime Sodium & Sulbactum Sodium Inj.Ceftriaxone Sodium Inj.Ceftriaxone Sodium & Sulbactum Sodium Inj.Ceftazidime Sodium Inj.Ceftazidime Sodium & Sulbactum Sodium Inj.Cefuroxime Sodium Inj.Cefuroxime Sodium & Sulbactum Sodium Inj.Cefoperazone Sodium Inj.Cefoperazone Sodium & Sulbactum Sodium Inj.Cefazolin Sodium Inj.Hydrocortisone Sodium Succinate Inj.Chloramphenicol Sodium Succinate Inj.

MANUFACTURING PROCESS AND FACILITYOur state-of-the-art factory has a significant footprint on a large allotment of land which is over 2.25 acres. The facility comprises of two highly specified manufacturing units, which have been designed and purpose built to meet stringent quality control requirements. Unit I is 30,000 square feet, and Unit 2 is 20,000 square feet. Both these units conform to WHO cGMP norms, with Unit 2 also certified for WHO cGMP.

Cross contamination is avoided because all primary processing areas are provided with filtered air and adequate pressure differentials. All processing is done in the utmost hygienic environment and all procedures to maintain high quality standards are well documented. There is continual training and supervision of our Standard Operating Proce-dures in place.

With most of the processing areas centrally air-conditioned, we guarantee that the process from washing to sterilization to filling is done via an automatic tunnel without any human contact.

Dependable delivery

We have strategically located the facility to benefit from rapid connections with both Eastern & Western express highways. Situated 70 kilometers from Mumbai provides the best of both worlds. We are close enough to the financial capital of India for logistics, but at a distance which provides our facilities and employees with a natural, pollu-tion free environment.

Liquid Injectable Ampoules1,44,00,000/year

PowderInjectableVials3,60,00,000/year

Liquid Injectable Vials3,60,00,000/year

All machines are made from SS316(L) Stainless steel

Quality standards achieved through investment in quality equipment

Automated washing and steril ization machine

Vial, ampoule and powder fil l ing & sealing machine

Autoclave cum bung processor

Pure steam generator

Purified water plant, Multicolumn distil lation plant

Separate AHU’s for critical areas

Oil free Air compressor

Boiler

Inspection and packing capabilities include fully

automatic and semi automatic labeling machine

Uninterrupted power supply with total power back-up

Receiving Warehouse SampleRaw Material

Manufacturing Process SampleApproval

Quality Control Testing

Finished GoodsWarehouse

Approval

Customer

Quality Control Testing

Obsession with quality and purity is the foundation of our operations.

There are no compromises made nor tolerated with hygiene. Every

employee is fully trained and inducted into our culture for following

strict guidelines to ensure optimal quality assurance for our

customers.

We have created an entire process where there is no human con-

tact and look into every detail of our site and systems to create

standards to achieve minimum defect rate. Our obsession with

purity has set the goal to attain 100% and achieve recognition for

achieving stringent global standards.

We have a rigorous preventive maintenance and quality control system in place for our equipment and

products. All equipment is serviced regularly, cleaned and tested to ensure optimal performance and

dependability by validation and calibration at regular intervals.

Corrective action wherever required is always taken for improvement and is introduced through a

proper change control system.

All samples are only released to market after a thorough and documented evaluation of both bulk and

finished products. Batch records are maintained for the lifetime of the product for verification purposes.

QUALITY CONTROL AND ASSURANCE

Highlights of our relentless obsession for purity

Continual investment in employee training to enhance skil ls.

Full medical examine and health checks for employees once per year

Complete bottom-to-top clean as per schedule

Water system has electro polished loops

Water is circulated to user point in closed loop system

Zero human intervention from washing, steril ization to fil l ing

Core processing areas are fitted with HEPA filtered air

Fil l ing is performed under laminar air flows (class 100)

Monolithic epoxy flooring in all core areas

Separate man and material entry

Fully equipped quality control laboratory

HPLC, FTIR, Double beam spectrophotometer,

stability chambers etc.

Separate wet lab and packing material testing labs

Microbiology Lab

Qualification of Analytical equipment’s and machines

Out of specification (OOS) investigation

Market complaint, CAPA and Feedback

Stability testing and annual product review

Material Management

CORPORATE SOCIAL RESPONSIBILITYSuccess for our business includes setting high standards for how we engage, contribute and care for our

local community, staff and the environment.

Sustainability as a businessWe invest heavily into our people with training, skil ls and rewarding them

for maintaining our exceptional standards for hygiene and quality. Every-

one at Micropure is engaged in the obsession for purity, and is provided

with the incentives, tools and systems to make it an integrated part of our

culture.

Sustainability in the local community

Micropure aids the economic and skil ls development of 200 local

citizens. Our directors personally oversee training programs, to ensure

that as our company grows, the community benefits too.

We continually seek ways to deliver positive outcomes locally. These

can range from sponsorship, to even providing extra bins to prevent

litter bugs.

Sustainability for the environment

Micropure has invested into clean energy, and is able to account for

our carbon footprint. We have enhanced the sustainability of our

operations with solar power and rainwater harvesting for reuse.

In the interests of beautification, environmental benefits and local community

engagement, we have an active tree planting scheme. And while on the

subject of trees, we have an internal program to minimise the use of paper,

by digitalizing all information to hopefully become paperless.

Eco

no

my

Society

Ecology

INVITATION FOR SITE VISITThere is no better way to understand our obsession with purity than to inspect our world-class facilities. You will experience firsthand the detail and lengths we go to, in order to deliver optimal certainty for quality pharmaceutical products.

You are warmly invited to ask any question, and request any documentation in order to conclusively understand our ability to service your manufacturing require-ments.

We look forward to meeting you soon.

Sincerely Yours,

The Micropure management and staff

CONTACT DETAILSMicropure Parenterals Pvt Ltd.Correspondence Address 302 Runwal Residency, Above ICICI Bank Ltd. D.K. Sandu Marg, Chembur (E), Mumbai - 400 071

Factory Address Plot 136, Village - Neharoli, Taluka - WadaPin 421 312 - Dist. Thane

Tel +91 22 252 32 098

Tele/Fax +912526 - 239064/239 139

Email mppl@micropure.in

Web www.micropure.inwww.mihellandlycos.com.au

© 2012 Micropure Parenterals Pvt Ltd. All rights reserved.

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