SMS Pharma successfully completes USFDA inspection at Telangana Central Laboratory Analytical Services
SMS Pharma successfully completes USFDA inspection at Telangana Central Laboratory Analytical Services
Telangana: SMS Pharma has announced the second successful completion of the United States Food and Drug Administration (USFDA) inspection at its Central Laboratory Analytical Services, located at, Gagillapur Village, Medchal Malkajgiri District, Hyderabad, Telangana.
The inspection, conducted from 23rd June 2025 to 25th June 2025, concluded with zero Form 483 observations.
An FDA Form 483 is issued to firm management at the conclusion of an inspection when an investigator(s) has observed any conditions that in their judgment may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts.
"The Company is committed to meeting the highest quality standards and is further committed to full compliance with CGMP & GLP regulations at all our manufacturing & Analytical facilities," SMS Pharma stated in a BSE filing.
The “Central Laboratory Analytical Services” is the company's independent testing laboratory.
Read also: SMS Pharma Visakhapatnam facility gets WHO Geneva prequalification
Established in 1990, SMS Pharmaceuticals Limited is a diversified and integrated pharmaceutical company specialising in API and intermediatesfor 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.
Read also: SMS Pharma gets one USFDA observation for Bachupally facility
