Shilpa Medicare Hyderabad division gets USFDA clearance
The USFDA clearance on the facility will enable the company to test and release batches into the US from this facility.
Karnataka: Shilpa Medicare has recently announced that the Company's Analytical Services Division situated at Nacharam, Hyderabad, Telangana, has received U. S. Food and Drug Administration (USFDA) clearance (EIR) for the inspection performed from 26 April 2022 to 29 April 2022.
This is the first US FDA inspection of this facility. The facility is identified as a testing laboratory in numerous Abbreviated New Drug Applications (ANDAs) filed by Shilpa Medicare Limited (Parent Organization) and its agreed parties.
The FDA clearance on the facility will enable the company to test and release batches into the US from this facility. This facility, after appropriate submissions, can also be used for testing and releasing batches into Europe and other markets of the world.
Medical Dialogues team had earlier reported that the U.S. Food and Drug Administration (USFDA) had issued four observations to Shilpa Medicare's Analytical Services Division, Hyderabad, after an inspection.
Read also: Shilpa Medicare gets 4 USFDA observations for Hyderabad division
The facility is involved in the analytical testing of drug products (Release & Stability), drug substances, raw materials & packing materials. It is also engaged in analytical method validations, method transfers, and conduct of other miscellaneous analytical studies.
Shilpa Medicare Limited started its operations as an API manufacturer in 1987 in Raichur, Karnataka- India.
Commercial production in the SML was started in November 1989. Today Shilpa Medicare Limited is a global brand in manufacturing and supplying affordable API and Formulation globally in different regulated markets.
Read also: Shilpa Medicare bags CDSCO nod for topical hemostatic spray of Tranexamic Acid
