API Plants
Active Pharmaceutical Ingredients (APIs) are the building blocks in the pharmaceutical industry. Indoco's API business has growth potential in both domestic as well as international markets. However, the distinct advantage emanates from the backward integration for our own ANDAs and Dossiers. All our plants are built as per regulatory requirements of USFDA and EDQM.
API Plant is approved by USFDA, EDQM and PMDA Japan.
Indoco is one of the fastest growing manufacturers and exporters of APIs and Advance Drug Intermediates. Our state-of-the-art manufacturing facilities offer products from gram to multi-ton levels.
Facilities:
Multipurpose facility to manufacture APIs for regulated markets
Approved by USFDA, TGA, LOCAL FDA, WHO, EDQM & EUGMP
Reactors (SS and GLR) capacity from 500 L to 4000 L
1000 L Hydrogenation facility
State of the art micronization Set-up
Approved by USFDA & WHO GMP
Smooth technology transfer from R & D to commercial level
Designed to manufacture developmental and preclinical compounds under cGMP
Reactor capacities from 16 L to 500 L
Purified Water System as per USP standards
Clean Room Area - Air Quality: Class 1,00,000 FS 209 D
Hydrogenation Facility: 2 L and 50 L
Operating Temperature Range: - 55°C to 250°C
Dedicated Multi product facility to manufacture APIs from 100 Kgs to 2000 Kgs
Designed to meet cGMP, EDQM and USFDA standards
Reactor (SS and GLR) capacities from 500 L to 2000 L
Multipurpose facility to manufacture advance intermediate and APIs for Emerging markets
Designed to meet Local GMP and WHO:GMP standards
Reactor (SS and GLR) capacities from 500 L to 4000 L
Esterification
Oxidation
Condensation
Diazotisation
Nitration
Reduction
Sulphonation
Alkylation
Hydrogenation
Epoxidation
Acylation
Halogenation
Amidation
Hydrolysis