APIs (Active Pharmaceutical Ingredients)
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.
We offer full range of services with respect to API supplies in Regulated markets. New APIs are developed through non-infringing processes, which assure commercial viability and hassle free launch of products.API Product List
Our API manufacturing facility is located in M.I.D.C. Industrial area, Patalganga and is surrounded by pharmaceuticals and petrochemicals companies.
Intermediate manufacturing area is with supply of 3 micron filtered air and release through 10 micron filter ventilation system.
Pharmazone is designed to maintain class 100 thousand conditions with proper pressure differentiate of filtered air through HVAC system.
Purified water system having DM plant with RO system.
Committed to green environment – Pretreated effluent release to common effluent treatment plant.
Conscious approach towards personnel safety and health, taken care by Environment, Health, Safety Department.
Facility approved by USFDA, TGA, Local FDA, WHO, Cofepris, EDQM, and EUGMP.
New state of the art API manufacturing facility being commissioned.
Operational volume will be 150 m3 with the combination of 20 Glass lined and Stainless steel reactors.
This facility is located in MIDC Industrial Area, Rabale and is surrounded by Pharmaceuticals and Engineering companies.
Finished Product Area is designed to maintain Class 100 thousand conditions with proper pressure differential of filtered air.
Intermediate manufacturing area is with supply of 3 micron filtered air through ventilation system.
Separate dissolution area with 3 micron filtered air supply through independent ventilation system.
Separate man and material entry for each manufacturing area.
Purified water system having DM plant with UF system.
Conscious approach towards personnel safety and health.
Site approved by USFDA & WHO GMP
Indoco offers its research and development capabilities to innovator and generic companies for the development of APIs & Intermediates.
Custom Synthesis of Molecules and Intermediates (Preclinical and Clinical)
Contract Research : Process Chemistry Research and Development
Non – Infringing Process Designing and Scale up
Analytical Method Development / Validation, Impurity Profiling and Polymorphic Studies
We undertake work as FTE or Fee for services model.
Indoco has state-of-the-art facilities for manufacturing of various APIs and Intermediates developed in R&D to commercial production. We undertake contract manufacturing of building blocks to innovator companies.
The manufacturing facilities hold good capacities from Kilo to Multi ton and are managed by efficient and skilled professionals. We ensure consistent quality, quantity and timely delivery of products as per customer specifications.
Indoco manufactures and exports APIs and Intermediates to Regulated and Emerging markets with necessary documentary and plant approval support.