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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.
info.milanlabs.com
QUALITY PRODUCTS
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 sec on is well equipped with professionals opera ng Sophis cated instruments for
performing analysis of incoming materials, in process and nished products.
The plants are inspected by the Drug Regulatory Authori es of various countries and the constant eorts by
the Quality Opera ons cell has enabled us to have a very good success rate so far with registra ons in several
countries.
An -bacterials
An -infec ves
An -allergics
Cardiovasculars
Anthelmen cs
An -malarials
An - diabe cs
Dosage
Forms
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APPROVALS WE HOLD
Our products are manufactured in facilities that have approvals from stringent regulatory authorities
like....
Botswana: Ministry of Health
Bhutan: Drug Regulatory Authority
Cte dIvorie : Ministry of Health
Democratic Republic of Congo: Ministry of Health
Ethiopia: Drug Administration and Control Authorithy
Ghana: Foods and Drugs Board
India: WHO cGMP Cer ed
info.milanlabs.com
MARKETS WE CATER
As on March, 2015, India Brand Equity Founda on quotes India as one of the fastest-growing pharmaceu cal
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 compe ve advantage.
The Indian pharmaceu cal industry was es mated 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 produc on 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 pharmaceu cal 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
Pharmaceu cal 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 pharmaceu cal
products. Pharma export market in India is very poten al for the buyers for procuring their required
pharmaceu cal formula ons in all the available dosage forms.
Milan has achieved remarkable success in expor ng pharmaceu cal products to over 43 countries spread in all
the con nents 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 pharmaceu cal formula ons to the markets where we are s ll not present.
www.milanlabs.com
REGULATORY AFFAIRS
Milan also has an independent regulatory aairs team which is dedicated for dossier prepara on and
coordina on with drug authori es of dierent countries. This team comprises of qualied individuals who are,
constantly upda ng their knowledge and informa on bank to make dossier which is country specic, ecient in
query solving and comple ng registra on formali es within melines.
This team is procient in regulatory submissions like CTD
ACTD
NeeS
NeeS
eCTD
Any other country specic format
Other
eCTD
CTD
info.milanlabs.com
ACTD
Marke ng Assistance
High Quality
Manufacturing
Regulatory Aairs
Complete Technical
Support
www.milanlabs.com
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: info@milanlabs.com, Website: www.milanlabs.com