Certificates & Accrediations > About Us
Anek Prayog Pvt Ltd has been accredited by reputed international as well as national regulatory authorities in the past few years.
- First Asian company to receive a Certificate of Suitability (CEP) for our core product Trimetazidine Dihydrochloride. Current CEP Number: RO-CEP 2007-245-Rev 02.
- EU cGMP certificate for Trimetazidine Dihydrochloride. Audited and Approved by EU/EDQM authorities in 2013 & 2017.
- The Korean FDA (MFDS) audited and approved our organization twice for products, namely Felodipine and Nicorandil in 2009 and 2013 respectively.
- The US FDA has inspected and classified our manufacturing facility as acceptable, as per US FDA regulatory requirements in 2011.
- WHO GMP approval in 2004, and periodic inspections after every two years since then.
- State FDA GMP approval since 1979.
- A Written Confirmation Certificate issued by CDSCO is available for WHO-approved products.
- The Mexican Authority (COFEPRIS) audited and approved the facility in December 2014 for products namely Amlodipine Besilate and Felodipine.
- Our Research and Development Center (situated in Mumbai) has been recognized by the “Department of Scientific and Industrial Research” (DSIR) since 1981.
- ANVISA Brazil audited and approved the facility in September 2024. CBPF or ANVISA GMP is available for two products namely Trimetazidine Dihydrochloride and Dexchlorpheniramine maleate
