ORCHEV Pharma is largest manufacturers of Famotidine located in India with full regulatory approvals like USFDA, CEP, WHO-GMP, WC, etc. – Last US-FDA Inspection in June2024, EIR received in September 2024 – Famotidine US-DMF # 36764 approved, GDUFA DMF Fees Paid & customer ANDA approval received. – CEP 2022-307 from EDQM – Chinese DMF # Y20220000306 registration successful with IDL…
Orchev Pharma Pvt. Ltd. is involved in the process of manufacturing quality Active Pharma Ingredients and Intermediates in accordance with GMP, USFDA and ICH Q7 guidelines. Our plant located at Rajkot has the following regulatory approvals for Ranitidine:
Active Pharmaceutical Ingredients Product Therapeutic Category Status Ranitidine HCl Antiulcer WHO-GMP, WC DMF, Risk Assessment Famotidine Antiulcer CEP 2022-307 USFDA Inspected (June24), US-DMF # 36764 Reviewed & ANDA Approved Chinese DMF # Y20220000306 with IDL Status “A“IL# 028647 & TDMF consolidated & approved by Taiwan FDADMF Filed with ANVISA – Brazil (DIFA # 25351441235202484)DMF filed with Korean FDA WHO-GMP, WC,…