ORCHEV Pharma is from leading manufacturers of Famotidine located in India. Famotidine is manufactured in USFDA, EU-GMP and COFEPRIS approved facility. Famotidine US-DMF # 36764 & GDUFA DMF Fees Paid, customer ANDA approval received. CEP 2022-307 from EDQM Chinese DMF # Y20220000306 registration successful with IDL Status “A” IL# 028647 & TDMF consolidated & approved by Taiwan FDA Famotidine DMF filed…
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 US-DMF # 36764, Completeness Assessment (CA) Passed.Chinese DMF # Y20220000306 with IDL Status “A“IL# 028647 & TDMF consolidated & approved by Taiwan FDADMF filed with Korean FDA WHO-GMP, WC, DMF Risk Assessments Telmisartan ARBs (Blood pressure) Commercial GMP Levetiracetam Antiepileptic Samples…