Regulatory Approvals

Orchev Pharma Pvt. Ltd. is involved in the process of manufacturing quality Ranitidine Hydrochloride in accordance with GMP, USFDA and ICH Q7 guidelines. Our plant located at Rajkot is manufacturing only one API, i.e., Ranitidine Hydrochloride. The plant has following regulatory approvals:



1) WHO GMP

2) EDQM - COS (CEP 2007 / 320)

3) Korean Food and Drug Administration (KFDA)

4) COFEPRIS - Mexican Health Authority

5) Written Confirmation for EU

6) Ranitidine registered with RUSSIAN - State registration of medicinal products

7) ISO 9001:2008 issued by TUV SUD

8) DMF filed with TPD - Canada