Orchev Pharma Pvt. Ltd. is involved in the process of manufacturing quality Active Pharma Ingredients in accordance with GMP, USFDA and ICH Q7 guidelines. Our plant located at Rajkot is manufacturing. The plant has the following regulatory approvals for Ranitidine:
1) USFDA [August 2018]
2) EU-GMP (AEMPS – Spain) [June 15]
3) EDQM – COS [June 15]
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
