SMS Pharma gains after Hyderabad facility completes USFDA inspection

SMS Pharmaceuticals rose 1.79% to Rs 221.80 after company announced that it has successfully completed a US Food and Drug Administration (USFDA) inspection at its API manufacturing facility located in Bachupally, Hyderabad, Telangana.

According to an exchange filing, the inspection was conducted from 17 March to 21 March 2025 and concluded with one observation in Form 483. The observation was 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 manufacturing capacity of 120 KL, specializing in niche small-volume and high-value molecules. It holds multiple regulatory approvals, including USFDA, EU GMP, KFDA, ANVISA, PMDA, and CDSCO.

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.”

The official announcement was made on Friday, 21 March 2025, after market hours.

SMS Pharmaceuticals is a diversified and integrated pharmaceutical company specializing in APIs and intermediates for global customers. The company operates two state-of-the-art manufacturing facilities in Hyderabad and Vizag, with capacities of 120 KL and 3,000 KL, respectively. The company has a proven track record of delivering quality products across a diversified portfolio of therapeutic segments, serving as a trusted partner to a global customer base in over 70 countries.

The companys consolidated net profit surged 58.9% to Rs 18.24 crore in Q3 FY25 as against Rs 11.48 crore recorded in Q3 FY24. Revenue from operations rose 7.4% to Rs 173.35 in the quarter ended 31 December 2024.

Related Posts

Three arrested after liquor bottles found at pharma firm

Patna: Three people were arrested and sent to jail after a large quantity of liquor bottles was found at Cellulas Pharma Private Limited in Kankarbagh during a raid by the…

NEXUS 2026 brings pharma experts together to explore next generation analytical technologies

Anton Paar India hosted the first day of NEXUS 2026 at Ramada by Wyndham, Navi Mumbai, bringing together leading experts, scientists, researchers and industry professionals from the pharmaceutical sector for…

Leave a Reply

Your email address will not be published. Required fields are marked *

You Missed

Three arrested after liquor bottles found at pharma firm

Three arrested after liquor bottles found at pharma firm

NEXUS 2026 brings pharma experts together to explore next generation analytical technologies

NEXUS 2026 brings pharma experts together to explore next generation analytical technologies

National Formulary of India 2026 Lists Unapproved Drugs; DCGI Seeks Urgent Explanation from IPC Over Regulatory Discrepancy

National Formulary of India 2026 Lists Unapproved Drugs; DCGI Seeks Urgent Explanation from IPC Over Regulatory Discrepancy

Six leading mental health organisations unite to launch ‘Humanising Medicine India Initiative’ on World Mental Health Day

Six leading mental health organisations unite to launch ‘Humanising Medicine India Initiative’ on World Mental Health Day

Cancer Drug Prices May Fall By Up To 70% As Government Caps Trade Margins: Sources

Cancer Drug Prices May Fall By Up To 70% As Government Caps Trade Margins: Sources

Gujarat FDCA cracks down on four firms for illegal drug sale; cancels licences of two

Gujarat FDCA cracks down on four firms for illegal drug sale; cancels licences of two