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) USFDA [August 2018]

2) EU-GMP (AEMPS Spain) [June 15]

3) EDQM - COS (R1- CEP-2007-320- Rev 02)

4) WHO GMP (local)

5) Written Confirmation for EU

6) Korean Food and Drug Administration (KFDA)

7) COFEPRIS - Mexican Health Authority [May 2013]

8) Ranitidine HCl registered with RUSSIAN - State registration of medicinal products

9) ISO 9001:2015 issued by TUV SUD

10) DMF filed with TPD Canada

11) Registration in Ukraine

12) Registration in Uzbekistan