Strides Pharma Science has secured Establishment Inspection Report (EIR) from the United States Food and Drug Administration (USFDA) for its flagship manufacturing facility in Bengaluru, indicating the successful closure of the inspection conducted at the facility. Earlier, the USFDA had conducted a current Good Manufacturing Practices (cGMP) inspection of the facility from May 12 to May 20, 2026. The inspection concluded with the issuance of a Form 483 that contained five observations.
The company submitted a comprehensive response addressing all observations within the stipulated timeline. Based on the company's response and the corrective and preventive actions implemented, the USFDA has classified the inspection outcome as Voluntary Action Indicated (VAI) and has issued the EIR.
The facility is the company's flagship manufacturing site and serves regulated and other international markets. The facility manufactures a broad portfolio of pharmaceutical dosage forms, including tablets, capsules and oral liquids, supporting both existing commercial products and future growth opportunities. The successful closure of the inspection further strengthens the company's regulatory track record and reinforces its commitment to supplying high-quality pharmaceutical products to patients across global markets.
Strides Pharma Science (Formerly Strides Shasun) is a pharmaceutical company with a major focus on development and manufacture of IP-led niche finished dosage formulations. It is also among the world’s largest manufacturers of soft gelatin capsules.
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| Cipla | 1426.20 |
| Lupin | 2193.00 |
| Zydus Lifesciences | 1120.00 |
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