GLP API, Starting Material & Intermediate Capabilities

Project Management

Chemveda’s GLP facility is equipped to deliver drug substances such as API, starting material and  intermediate from gram to few kg scales intended for non-clinical laboratory studies and regulatory submissions. The synthesis capabilities are designed to operate in the range of -80 °C to 200 °C and all the resulting samples are then analysed in a DCGI-CDSCO (Drugs Controller General of India-Central Drugs Standard Control Organisation) certified QC lab and released after the final review of QA.

To give this facility a wider range in terms of its purification capabilities it has also been complemented with a standalone 150L MPLC (Medium Pressure Flash Liquid Chromatography) instrument. The key utility here is to purify less pure and overly bulky chemical substances under safe, medium pressure conditions at a faster pace.

In addition to this, Chemveda also supports its collaborators with eCTD ready CMC documentation required for IND filing.

From concept to the clinic!
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