Successful completion of USFDA inspection at SMS Pharmaceuticals Ltd's Hyderabad facility

SMS Pharmaceuticals Limited (SMS Pharma) (NSE: SMSPHARMA; BSE:532815) is pleased to announce the successful completion of a US Food and Drug Administration (USFDA) inspection at its Active Pharmaceutical Ingredient (API) manufacturing facility situated at Bachupally, Hyderabad, Telangana.

The inspection, conducted from March 17 to March 21, 2025, concluded with one observation in Form 483. The observation is procedural in nature and does not relate to data integrity or product quality. The Company will provide the necessary response to USFDA within the stipulated period.

The Hyderabad facility has a 120 KL manufacturing capacity for niche small-volume and high-value molecules. It has multiple regulatory approvals, including USFDA, EU GMP, KFDA, ANVISA, PMDA and CDSCO.

Commenting on this achievement, Mr. P. Vamsi Krishna, Executive Director, stated: "The successful completion of the USFDA inspection underscores our commitment to quality, compliance and global regulatory standards. This is the 6th USFDA inspection for this facility, reflecting our team's dedication to maintaining the highest manufacturing practices. This milestone further strengthens our reputation as a trusted partner in the pharmaceutical industry, ensuring an uninterrupted supply of high-quality APIs to key international markets."

Shares of SMS Pharmaceuticals Limited was last trading in BSE at Rs. 217.90 as compared to the previous close of Rs. 213.30. The total number of shares traded during the day was 17715 in over 615 trades.

The stock hit an intraday high of Rs. 219.20 and intraday low of 212.90. The net turnover during the day was Rs. 3823483.00.

Source : Equity Bulls

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SMSPharmaceuticals INE812G01025 USFDA Inspection SuccessfulCompletion