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Tonira's
production capability for the manufacturing of Active
Pharmaceutical Ingredients (APIs) can be classified into three
groups:
*
Bulk Products at tonne level production per month
* High Cost Products at 100kg levels per month
* Very High Cost Products at 10-15 kgs. per month
(Chiral Molecules) (Contract Manufacture)
OUR
CAPABILITY : Manufacture of Active Pharmaceutical Ingredients
* By Patent Non-infringing Process
* By Good Manufacturing Practices
* By Commitment to Environmental Protection
THE FACILITY
Tonira
has a WHO-GMP approved facility
for the manufacture of APIs, which consists of MS Glass Lined
Reactors, SS Reactors, Crystallisers, Certrifuges and Dryers.
The API processing area is designed under regulations of Clean
Room Concept, with Air Handling Systems and other regulations.
The
manufacturing is supported by an In-process Control Laboratory
to check and ensure the smooth running of unit operations.
There is a full-fledged maintenance team for Civil, Mechanical,
Electrical and Instruments. The team ensures systems validation
at regular intervals.
THE
TEAM
The Manufacturing
Team consists of Graduate
Chemists, Chemical Engineers and Engineers from recognized
universities, having long experience in the manufacture of
Active Pharmaceutical Ingredients. The Manufacturing and Analytical
Team has the Approved Chemist
Status granted by the Food and Drug Administration of Government
of India.
REGULATORY
COMPLIANCE
There is a Regulatory Compliance Team to monitor all GMP aspects,
including documentation of all manufacturing and other related
aspects.
THE ACHIEVEMENTS
Tonira's products are exported to over 40 countries and hence
has been granted 100% Export Oriented
Unit status by the Governement of India.
Tonira
is a recipient of Export Award of
Directorate General of Foreign Trade for two successive years.
Tonira caters to Tailor-made Specifications
of different customers in terms of Impurity Profile, Particle
Size, Polymorph Compositions and other aspects.
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