milan lab

Curing mankind since 1976, Miln Laboratories (India) Private Limited is a

flourishing enterprise dedicated to delivering a product that can take care of

you and your loved ones. We are involved in manufacturing, developing and

exporting pharmaceuticals, which have been produced in strict cGMP

compliant facilities.

We have three dedicated plants, first for manufacture

of Penicillin formulations, second for non-Penicillin

formulations and third for liquid orals, creams and

ointments. While the range of penicillin dosage forms

includes tablets, dry syrups and capsules, the non-

penicillin range covers tablets, capsules, dry syrups,

liquid orals and creams and ointments.

We believe that our cGMP-imbued personnel are our

biggest assets as they perpetually upgrade their knowledge and apply the same

for producing & delivering quality products. Thus, the result of this atude is a

pharmaceucal product produced by professionals through a blend of scienc

acuity and pharmaceucal art.

The fact that we are present in more than 43 countries with over 100 markeng authorizaons and the

several Quality Cercaons, awards and approvals that we have to our credit are the evidence of the same.

Connual improvement is our policy as the company has been adapng to current trends and requirements

while adding newer approvals and opening newer markets for business with each passing day.

The latest cGMP norms are a habit and Quality is our culture.

Upcoming Manufacturing Facility

We are presently expanding and building a new manufacturing facility to cater to the regulated

markets - USA and UK.

This fully integrated state-of-the-art manufacturing plant is situated at Dahej (Guajarat), in an area of

37664 Sq. Mt.

The facility will be dedicated for Oral solid dosage forms.

ABOUT US

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Milan has made its own contribuon with a wide range of well-known products in various segments. Our wide

range of products encompasses an array of therapeuc segments.

The present product range of Milan is divided into its divisions focusing on various therapeuc segments.

v An-bacterials

v An-infecves

v An-allergics

v Cardiovasculars

v Anthelmencs

v An-malarials

v An- diabecs

v An-inammatory, An-pyrecs, Analgesics

THERAPEUTIC SEGMENTS COVERED

Assurance of quality is provided by the quality systems adopted by Milan. The in-process controls, usage of

qualied machinery, validated manufacturing processes, validated cleaning procedures, strict environmental

monitoring and microbiological controls in all areas, are just a few of the many controls exercised by Milan to

ensure that Quality is built into the product. Furthermore, adequate training of personnel, maintaining

hygiene and cleanliness, proper recording and data handling compliment to our stringent quality policy.

The Quality Control secon is well equipped with professionals operang Sophiscated instruments for

performing analysis of incoming materials, in process and nished products.

The plants are inspected by the Drug Regulatory Authories of various countries and the constant eorts by

the Quality Operaons cell has enabled us to have a very good success rate so far with registraons in several

countries.

QUALITY PRODUCTS

Dosage

Forms

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Our products are manufactured in facilities that have approvals from stringent regulatory authorities

like....

APPROVALS WE HOLD

South Africa: Medicines Control Council (PIC Country)

Ghana: Foods and Drugs Board

Ethiopia: Drug Administration and Control Authorithy

Democratic Republic of Congo: Ministry of Health

Nigeria: National Agency for Food & Drug Administration & Control

Namibia: Namibia Medicines and Regulatory Council

Malawi: Pharmacy, Medicines and Poison Board

Kenya: Pharmacy & Poisons Board

Sudan: Ministry of Health

Sierra Leone: Pharmacy Board

Republic of Angola: Ministry of Health

Botswana: Ministry of Health

Bhutan: Drug Regulatory Authority

Cte dIvorie : Ministry of Health

Uganda: National Drug Authority

United Kingdom: Medicines and Healthcare products Regulatory Agency

Tanzania: Tanzania Food and Drugs Authority

Zimbabwe: Medicines Control Authority Of Zimbabwe

Ukraine: Ministry of Health

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India: WHO cGMP Cered

MARKETS WE CATER

As on March, 2015, India Brand Equity Foundaon quotes India as one of the fastest-growing pharmaceucal

markets in the world and that India has established itself as a global manufacturing and research hub. A large raw

material base and the availability of a skilled workforce give the industry a denite compeve advantage.

The Indian pharmaceucal industry was esmated to be worth US$ 12 billion in 2013 and is expected to touch

US$ 100 billion by 2025

Globally, India ranks third in terms of volume of producon and fourteenth largest by value and is also

expected to move up to eleventh place by 2017

Indian pharma sales stood at US$ 22.6 billion in 2012 and is expected to register US$ 27 billion by 2016 growing

at a rate of 14.4 percent

The pharmaceucal exports market in India is growing at a very rapid rate.

India exports to more than 200 countries; its share of exports is expected to grow manifold

Pharmaceucal exports from India grew at a rate of 1.2 per cent to reach US$ 14.84 billion in 2013-14

Looking at this the world is now considering India as the protable venue to manufacture its pharmaceucal

products. Pharma export market in India is very potenal for the buyers for procuring their required

pharmaceucal formulaons in all the available dosage forms.

Milan has achieved remarkable success in exporng pharmaceucal products to over 43 countries spread in all

the connents of the world. We are looking forward to make such e-ups and nd new customers to whom we can

oer our spare capacity and export pharmaceucal formulaons to the markets where we are sll not present.

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REGULATORY AFFAIRS

Pharmaceucal Industry is a non-stagnant, forever evolving

industry, that demands new formulaons and improved

ecacy. To comply with these needs and to deliver maximum

paent compliance, a dedicated Research and Development

Facility is constantly engaged in developing dierent types of

generic/o-patent formulaons. Apart from working on new

products, the R&D also improvises on the exisng formulaons

at Milan, thus ensuring not only the quality but also beer

products. The R&D is also engaged in analycal method

development and validaon for the drug and drug formulaons

under development.

The Research and Development team comprises of highly

competent professionals including experts with more than 25 years of experience in pharmaceucals who are

passionate about the cra of Formulaons and Development.

RESEARCH AND DEVELOPMENT

Milan also has an independent regulatory aairs team which is dedicated for dossier preparaon and

coordinaon with drug authories of dierent countries. This team comprises of qualied individuals who are,

constantly updang their knowledge and informaon bank to make dossier which is country specic, ecient in

query solving and compleng registraon formalies within melines.

This team is procient in regulatory submissions like -

CTD

ACTD

NeeS

eCTD

Any other country specic format

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CTD ACTD

NeeS eCTD

Other

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YOUR TRUSTED PARTNER FOR ALL QUALITY PHARMACEUTICAL REQUIREMENTS

Research & Development

Markeng Assistance

High Quality

Manufacturing

Complete Technical Support

Regulatory Aairs

303-304, Odyssey IT Park, Wagle Estate, Road No. 9, Thane (w) - 400604, Maharashtra, India.

Tel No.: +91-22-25877733/ 34, Fax No: +91-22-25877736

Email: [email protected], Website: www.milanlabs.com

We manufacture only those quality products,

which we can safely give to our

Parents and Children.

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