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Caplin Steriles Gummidipoondi facility gets zero USFDA observations
![Caplin Steriles Gummidipoondi facility gets zero USFDA observations Caplin Steriles Gummidipoondi facility gets zero USFDA observations](https://medicaldialogues.in/h-upload/2024/03/09/750x450_233940-usfda-inspection-50-2.webp)
Mumbai: Caplin Point Labs has announced that the United States Food and Drug Administration (US FDA) has concluded an unannounced inspection with zero observations at Caplin Steriles' injectable and ophthalmic manufacturing facility located at Gummidipoondi.
The inspection was conducted between August 5th and 9th, 2024.
"This is to inform you that the United States Food and Drug Administration (US FDA) conducted an unannounced inspection of Caplin Steriles’ injectable and ophthalmic manufacturing facility located at Gummidipoondi. The inspection was conducted between August 5th and 9th, 2024 and concluded with zero observations," the Company stated in a BSE filing.
Read also: USFDA nod to Caplin Steriles Timolol Maleate Ophthalmic Solution
Caplin Steriles Limited, a Subsidiary of Caplin Point Laboratories Limited, is a sterile product manufacturing company that is approved by several regulatory agencies such as US FDA, EU-GMP, ANVISA and INVIMA. Caplin Steriles Limited, has developed and filed 42 ANDAs in USA on its own and with partners, with 30 approvals so far. The Company is also working on a portfolio of 40+ simple and complex Injectable and Ophthalmic products, that it intends to file over the next 4 years. The company also has multiple products filed with several approvals in non-US markets such as Mexico, Australia, Canada, South Africa etc
Read also: USFDA nod to Caplin Steriles Timolol Maleate Ophthalmic Solution
Ruchika Sharma joined Medical Dialogue as an Desk Editor for the Business Section in 2019. She covers all the updates in the Pharmaceutical field, Policy, Insurance, Business Healthcare, Medical News, Health News, Pharma News, Healthcare and Investment. She has completed her B.Com from Delhi University and then pursued postgraduation in M.Com. She can be contacted at editorial@medicaldialogues.in Contact no. 011-43720751
Dr Kamal Kant Kohli-MBBS, DTCD- a chest specialist with more than 30 years of practice and a flair for writing clinical articles, Dr Kamal Kant Kohli joined Medical Dialogues as a Chief Editor of Medical News. Besides writing articles, as an editor, he proofreads and verifies all the medical content published on Medical Dialogues including those coming from journals, studies,medical conferences,guidelines etc. Email: editorial@medicaldialogues.in. Contact no. 011-43720751