October 2, 2022
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  • Flagship Stelis Biopharma Facility Receives USFDA EIR for Pharmaceuticals at its Bengaluru Facility

Flagship Stelis Biopharma Facility Receives USFDA EIR for Pharmaceuticals at its Bengaluru Facility

By on September 1, 2022 0

Stelis Biopharma Limited, the biologics arm of Strides Pharma Science Limited, has announced that it has received the Establishment Inspection Report (EIR) from the United States Food and Drug Administration (USFDA) for the inspection pharmaceutical product (DP) facility that was completed at its flagship manufacturing facility. site (unit 2) located in Bangalore, India.

This result for the DP facility comes after the USFDA’s on-site pre-clearance inspection (PAI) at the flagship Stelis manufacturing facility for multiple partner product submissions to the agency. Unit 2 facility has high end automated DP lines integrated with isolators to convert drug substances (DS) into stable formulations and will terminate in the same facility in all injectable formats including cartridges, pens , auto-injectors and pre-filled syringes. , liquids and freeze-dried vials.

Arun Kumar, Founder, said, “I am delighted with the USFDA’s nod to the DP capabilities of our flagship facility, a second major win after receiving EU-GMP approval in June 2022. The EIR from the USFDA now also paves the way for revenue from the site’s commercial services over the next two quarters after our partners have received respective product approvals. We’ve had an exciting year so far, and we continue to deliver even better financial results as we accelerate and capitalize on opportunities in the global CDMO landscape.”

As a fully integrated biologics CDMO, Stelis can offer a full range of services from its Unit 2 facility. In addition to DP capabilities, the facility has proven technical expertise and capabilities to manufacture DS on microbial, mammalian and various other technology platforms with world-class cGMP, regulatory and quality systems. While microbial DS is already in service, mammalian DS capabilities designed on industry-leading single-use bioreactor (SUB) systems will be available to partners later this month (September 2022).

Unit 2’s integrated capabilities provide significant operational flexibility, greater efficiency, and varied range within a single principle. Earlier in June 2022, the factory received European Union Good Manufacturing Practices (EU-GMP) approval.

Stelis continues to grow its customer base with global partnerships and the integration of new programs on the drug substance and drug product side. It remains a major player in biologic CDMO given its comprehensive capabilities, high quality systems and large commercial scale with over 48,000 liters of drug substance in all modalities and over 400 million units of capacity filling-finishing.

As of 10:58 am, Strides Pharma Science Ltd is currently trading at Rs333.05 per share, up Rs2.15 or 0.65% from its previous close of Rs330.90 per share on BSE.

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