RPG Life Sciences has multi-location manufacturing facilities. The Formulation and Biotech API facilities are located at Ankleshwar Gujarat and the Synthetic API facility at Navi Mumbai, Maharashtra.

All facilities are cGMP compliant and WHO GMP certified. In addition, the Formulation facility is U.K. MHRA approved and the Synthetic API facility is approved by TGA Australia.

All facilities have independent Quality Control and Quality Assurance functions ensuring high standards of Product Quality.

Synthetic API:

The cGMP compliant manufacturing facility at Navi Mumbai produces Synthetic APIs / Bulk Drugs by organic synthesis route. The APIs produced cover a broad range of therapeutic categories. This facility includes two multi-purpose plants and a dedicated plant for Immunosuppressants. The plants are approved by TGA Australia for various products as well as by WHO.

The state-of-the-art manufacturing facilities adhere to stringent regulatory guidelines. The plants comply with the internationally accepted International Conference on Harmonization (ICH) guidelines in product development and manufacturing. Independent quality control and quality assurance teams ensure multi-stage quality compliance.

Certificate of Suitability (CoS) Available

US DMF Available

Formulation:

RPGLS has two cGMP compliant production facility for Finished Dosage Forms at Ankleshwar, Gujarat. The first facility caters to the Domestic and RoW markets. It is WHO GMP and Schedule M approved. The facility has dedicated products lines for oral dosage forms including Tablets, Capsules, Liquids and Powder.

The second facility is WHO GMP and UK MHRA approved. It is a state-of-the-art manufacturing facility catering to various regulated markets like UK, France, Canada, Czech Republic and other emerging markets. The facility is USFDA compliant and is ready for USFDA audit.

The facilities are certified to be compliant with the Good Laboratory Practices(GLP) requirements of Schedule L1 of Drugs and Cosmetics rule by Food & Drugs Control Administration, Gujarat state

Biotechnology
 
This facility at Ankleshwar, Gujarat produces API using Fermentation Technology. The plant is cGMP compliant and approved by WHO GMP.

Oncology and Immunosuppressants are the major products of the Biotech plant. The Product quality complies with stringent USP & Pharm Euro standards.

RPG Life Sciences has been the first in India to produce Cyclosporin, Daunorubicin, Doxorubicin, Epirubicin and Idarubicin.

Production Infrastructure:
A fully automated plant
Total fermentation capacity 34 KL
Well equipped with pilot fermentors for efficient scale-up
Dedicated area for Immunosuppressants

US DMF Available