We have a pipeline of 8 biosimilar products (produced by recombinant biotechnology in E.Coli) at various stages of development, including 2 in confirmatory clinical trials and 3 in pre-clinical toxicity studies.

Somatropin For Injection Ph.Eur

• PCT’s have been filed and National Phase filings are under progress in various countries.
• Non-solvent (aqueous) based drug substance purification process.
• Pre-clinical toxicity studies have been successfully completed as per schedule Y of Drugs & Cosmetics Act, India.
• Safety & Efficacy clinical trial (phase-III) is in progress.

Teriperatide Injection

• Drug: Biologically active N-terminal portion of Parathyroid Hormone.
• IN and PCT applications have been filed.
• Non-infringing Cloning, Fermentation and Purification technology.
• Pre-clinical toxicity studies have been successfully completed as per schedule Y of Drugs & Cosmetics Act, India.

Platelet Derived Growth Factor (PDGF-BB) Gel

• Drug Class: Growth Factor.
• INN: Becaplermin.
• Novel cloning, Fermentation and purification technology.
• Developed novel gel formulation; Indian patent is filed.
• Pre-clinical toxicity studies have been successfully completed as per schedule Y of Drugs & Cosmetics Act, India.

Filgrastim Injection (G-CSF)

• Drug Class: Colony stimulating factor.
• Non-infringing Cloning, Fermentation and Purification technology.
• Non-solvent (aqueous) based drug substance purification process.
• PCT application has been filed.
• Drug Substance is complying with Ph.Eur monograph specifications.
• Pre-clinical toxicity studies as per EMEA Biosimilar guideline for Filgrastim are in progress using Neupogen® of Amgen, Germany as reference product.

For all the above products, the cell banks (MCB & WCB) are prepared and characterized as per ICH Q5B & Q5D guidelines. And also both the Drug substance and drug product are completely characterized as per ICH Q6B guideline and compared with the reference medicinal products.

For more information about our existing portfolio and our pipeline products please e-mail us.