Shilpa Medicare Analytical Services Division gets 2 minor observations from USFDA

Published On 2023-03-11 08:30 GMT   |   Update On 2023-03-11 08:30 GMT
Advertisement

Karnataka: Shilpa Medicare has announced that the US Food and Drug Administration (USFDA) has closed the inspection with two minor observations at the company's Analytical Services Division situated at Unit 7, Nacharam, Hyderabad, Telangana. This is a full GMP inspection.

The unit has been inspected by US FDA from 08 March 2023 to 10 March 2023.

"The Company will be submitting the responses to US FDA observations within stipulated timeline and will work towards implementing the corrective actions to address the observations," Shilpa medicare stated in a recent BSE filing.
Advertisement

"The inspection is closed with 2 minor observations, which are related to improvements in existing procedures and are addressable," the company added.

This is the second US FDA inspection on the site.
The initial inspection was done during April 2022, for which the GMP clearance (EIR) was issued in July 2022.
The facility is involved in analytical testing of drug products, drug substances, raw materials & packing materials. It is also engaged in analytical method validations, method transfers and conduct of other miscellaneous studies. This facility is involved in the testing of US/EU & other markets commercial batches.

Read also: Shilpa Medicare Hyderabad division gets USFDA clearance

Shilpa Medicare Limited started its operations as API manufacturer way back in 1987 at Raichur, Karnataka- India. The commercial production in the SML was started in November 1989. Today Shilpa Medicare Limited is a global brand in manufacturing and supplying of affordable API and Formulation globally in different regulated markets.

Read also: Shilpa Medicare Bengaluru facility gets registered with Ministry of Health, UAE

Tags:    

Disclaimer: This website is primarily for healthcare professionals. The content here does not replace medical advice and should not be used as medical, diagnostic, endorsement, treatment, or prescription advice. Medical science evolves rapidly, and we strive to keep our information current. If you find any discrepancies, please contact us at corrections@medicaldialogues.in. Read our Correction Policy here. Nothing here should be used as a substitute for medical advice, diagnosis, or treatment. We do not endorse any healthcare advice that contradicts a physician's guidance. Use of this site is subject to our Terms of Use, Privacy Policy, and Advertisement Policy. For more details, read our Full Disclaimer here.

NOTE: Join us in combating medical misinformation. If you encounter a questionable health, medical, or medical education claim, email us at factcheck@medicaldialogues.in for evaluation.

Our comments section is governed by our Comments Policy . By posting comments at Medical Dialogues you automatically agree with our Comments Policy , Terms And Conditions and Privacy Policy .

Similar News