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 ...
The European Directorate for the Quality of Medicines and Healthcare (EDQM) has published a new general chapter (2.6.32) in the European Pharmacopoeia (Ph. Eur.) supplement 10.3. The European ...
Smruthi Organics Limited has received an "Attestation of Inspection" from the European Directorate for the Quality of Medicines & HealthCare (EDQM), Council of Europe, following the inspection ...
"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 ...
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 ...
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 ...
EDQM analyzed a random sample of 30 deficiency letters sent after carrying out initial evaluations of new CEP applications. The top deficiency was a lack of details or poor description of the ...
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 ...
Some results have been hidden because they may be inaccessible to you
Show inaccessible results