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Click to view the ICH Q 7 Compliance Certificate from PharmAssess/UK, for Patalganga API Site.
You may please contact PharmAssess directly for a copy of the audit report.

 
API Plants :

Active Pharmaceutical Ingredients (APIs) are the building blocks in the pharmaceutical industry. India is fast emerging as a powerhouse of API production. According to industry reports, the upcoming and mid-cap API manufacturers in the country increasingly favour trying the litmus test in the European capitals first before taking on the most lucrative and the most challenging US market. As a result, all our plants are built as per regulatory requirements of USFDA and EDQM.

Indoco’s strategy is to gradually move up its value chain and “Integrate Backward” into API business and hence change its role from a 'Contract Manufacturer of Finished Dosage Forms' to be a 'Complete Solutions Provider'. This will allow Indoco to exercise complete control on the supply chain and emerge as a preferred partner for global companies.

Indoco is one of the fastest growing manufacturers and exporters of APIs and Advance Drug Intermediates. Our four state of the art manufacturing facilities offer products from gram to multi-ton levels.


MULTI-TON PLANT

  • Multipurpose facility to manufacture API's for regulated markets
  • Designed to meet cGMP, EDQM and USFDA standards
  • Two Independent Pharma manufacturing Zones
  • Reactors (SS and GLR) capacity from 500 L to 4000 L
  • 1000 L Hydrogenation facility
  • State of the art micronization Set-up


THE KILO PLANT


  • USFDA / EDQM approvable small volume high value API's manufacturing facility
  • 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

MID-VOLUME PLANT
  • Dedicated Multi product facility to manufacture API's 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


INTERMEDIATE PLANT

  • Multipurpose facility to manufacture advance intermediate and API's for Emerging markets
  • Designed to meet Local GMP and WHO:GMP standards
  • Reactor (SS and GLR) capacities from 500 L to 4000 L


REACTION CAPABILITIES

  • Esterification
  • Oxidation
  • Condensation
  • Diazotisation
  • Nitration
  • Reduction
  • Sulphonation
  • Alkylation
  • Hydrogenation
  • Epoxidation
  • Acylation
  • Halogenation
  • Amidation
  • Hydrolysis

(Click here to view API product list)