By: IPP Bureau
Last updated : December 06, 2025 10:52 am
Ipca Laboratories receives three observations from USFDA for API facility at Tarapur
IOL Chemicals & Pharmaceuticals receives EDQM CEP certificate for Minoxidil
European Directorate for the Quality of Medicines & Health Care (EDQM) has granted a Certificate of Suitability for IOL Chemicals & Pharmaceuticals Ltd's API product "MINOXIDIL" on 4th December 2025. Minoxidil is primarily used as a topical treatment for hereditary hair loss.
Ipca Laboratories receives three observations from USFDA for API facility at Tarapur
Ipca Laboratories Limited has announced that the US FDA conducted the inspection of the company's Active Pharmaceutical Ingredients (APIs) manufacturing facility situated at Tarapur, Palghar, Maharashtra from 1st December, 2025 to 5th December, 2025. At the conclusion of the inspection, US FDA has issued a Form 483 with three observations. The company will submit its comprehensive response on these observations to the US FDA within the stipulated time and shall work closely with the agency to resolve these issues at the earliest.
Anuh Pharma granted CEP from EDQM for Sulfadimethoxine
Anuh Pharma Limited has been granted the Certificate of Suitability (CEP) from the European Directorate for the Quality of Medicines & HealthCare (EDQM) for Sulfadimethoxine. This approval reinforces Anuh Pharma's commitment to delivering high-quality Active Pharmaceutical Ingredients that adhere to the most stringent global regulatory standards. The CEP for Sulfadimethoxine will enable expanded access to regulated markets and support our customers with enhanced reliability, compliance, and supply security.