SMS Pharma Gets EIR for Hyderabad API Facility

31 May 2025 CW Team

SMS Pharmaceuticals Limited announced the receipt of the Establishment Inspection Report (EIR) from the United States Food and Drug Administration (USFDA) for its Active Pharmaceutical Ingredient (API) facility at Bachupally, Hyderabad. The inspection was conducted between 17th and 21st March 2025.

The inspection concluded with one procedural observation on Form 483, which has already been addressed by the company. The issuance of the EIR marks the formal closure of the audit.

The Hyderabad unit has a manufacturing capacity of 120 kilolitres and specialises in niche, small-volume, high-value molecules. It holds multiple global regulatory approvals including those from USFDA, European Union Good Manufacturing Practice (EU GMP), Korea Food and Drug Administration (KFDA), Brazilian Health Regulatory Agency (ANVISA), Pharmaceuticals and Medical Devices Agency (PMDA), and Central Drugs Standard Control Organisation (CDSCO).

Established in 1990, SMS Pharma serves global clients across over seventy countries, with facilities in Hyderabad and Vizag. The company is supported by in-house research and development capabilities and operates in a wide range of therapeutic categories.

Source:
SMS Pharmaceuticals Limited

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