Updates to Ph. Eur. include validated tests for N-nitrosamine impurities in sartan APIs. Vielle (EDQM): The new chapter ‘Test for bacterial endotoxins using recombinant factor C’ (2.6.32) describes a ...

As drug manufacturing and standards grow, pharmacopeias must adapt to meet new challenges. Pharmacopeias have historically provided collections of medical recipes intended to ensure accurate ...

"The inspection was focused on the application for certificate of suitability for the dossier of Cefaclor along with facility inspection for Quality Management Systems based on cGMP as laid under ...

The European Directorate for the Quality of Medicines & Health Care (EDQM) has granted a Certificate of Suitability (CEP) for ...

“EDQM may, therefore, block applications at receipt from May 2024 in case these are considered deficient to start the assessment process.” The directorate published the updated guideline days before ...

THANE, India, July 30, 2025 /PRNewswire/ -- Fermenta Biotech Limited ("Fermenta"), a pioneer in pharmaceutical and nutritional ingredients; one of the world's leading manufacturers of Vitamin D3, is ...

Pantoprazole Sodium Sesquihydrate are proton pump inhibitors used in drugs to suppress gastric acid secretion. The company started production of Pantoprazole Sodium Sesquihydrate in Q3 FY 2020 at its ...

EDQM began piloting real-time remote inspections, which it refers to by the abbreviation RTEMIS, in 2020 in response to travel restrictions. With the vast majority of the around 40 on-site inspections ...

Shilpa Medicare share price rose in the early trade on October 4 after the company's arm received certification from a European medical agency. At 09:24am, Shilpa Medicare was quoting at Rs 812.75, up ...