– 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 Status “A”
– Famotidine DMF Filed with ANVISA – Brazil (DIFA # 25351441235202484)
– IL# 028647 & TDMF consolidated & approved by Taiwan FDA
– Famotidine DMF filed Korean FDA.
– Iran MOH Registration
– WHO-GMP, WC, DMF, Risk Assessments Reports, etc. are available with ORCHEV.

Famotidine installed production capacity of 150 MT/year, largest amongst Famotidine producers.

All key intermediates of Famotidine are manufactured in-house in our USFDA/EU-GMP approved facility, directly giving us better control of supply chain, quality, and cost.

ORCHEV – Best Famotidine Manufacturer:
– Largest producer of Famotidine with 150 MT/year capacity
– Fully backward integrated: In-house production of key intermediates
– Regulatory approvals: USFDA (June 2024 inspection, EIR received), CEP, WHO-GMP, China DMF, Korea DMF
– Top exporter in 2024
– Unique combination of global compliance and lowest pricing

Intermediates of Famotidine: We are offering commercial supplies of Famotidine intermediates as well. Intermediates being part of our DMF, customers are assured of full documentation, audit, and GMP controls for intermediates as well.

Famotidine is a histamine H2 receptor antagonist medication that decreases stomach acid production. It is used to treat peptic ulcer disease, gastroesophageal reflux disease, and Zollinger-Ellison syndrome. It is taken by mouth or by injection into a vein. It begins working within an hour.

Possible use of Famotidine in COVID-19 is being studied in the US. Few reputed medical journals have reported Famotidine use associated with improved outcomes in COVID-19 patients.

Fabricante da Famotidina fabricante de famotidina Famotidine Hersteller producent famotydyny فیموٹائڈائن مینوفیکچرر ফ্যামোটিডিন প্রস্তুতকারক Famotidine制造商 ファモチジンメーカー famotidine 제조업체 Nhà sản xuất Famotidine виробник фамотидину Производитель FAMOTIDINE تولید کننده فاموتیدین Produsen Famotidine

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Since the beginning of operations in 1989, Orchev Pharma Pvt. Ltd. has quickly emerged as a leading manufacturer of high-quality pharmaceutical raw material in the Gujarat State of India. What separates Orchev from other trusted manufacturers is not only that we manufacture excellent quality APIs and intermediates; provide excellent services to customers, which additionally includes small scale manufacturing of product for trial supply and full-scale manufacturing for commercial supply. Orchev employs chemists, chemical engineers, microbiologists of the highest caliber and maintains the quality assurance standard.

With the aim to manufacture high-quality Ranitidine, Famotidine, Telmisartan, and Levetiracetam, our organization has believed in continuous development and evaluation.

With our proven experience and expertise; Orchev manufactures under (fully complies with) the standards of USFDA, CEP and WHO-GMP. We have been audited & Approved by EDQM, AEMPS(Spain), Korean Food and Drug Administration (KFDA), and COFEPRIS – Mexican Health Authority.  Orchev Pharma Pvt. Ltd. is an ISO 9001:2015 company.  In August 2018, the USFDA inspected our manufacturing facility which was cleared with ZERO 483.

What’s new:

2023 a year of Events for API – Famotidine:

• ORCHEV’s US-DMF#036764 for Famotidine passed CA and the customer received approval of ANDA in October 2023.
• Received CEP 2022-307 for Famotidine in August 2023 from EDQM.
• Chinese DMF # Y20220000306 for Famotidine registration successful with IDL Status “A” in December 2023.

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Since September 2014, Orchev took the next step in its growth by setting up a separate R&D team. The team is headed by scientist have several years of experience in Pharma Research. R&D Teams’ main focus is to develop a process for the product of Orchev’s interest.

Our R&D team is working to add new products to our API portfolio.  Famotidine, Allopurinol, and Levetiracetam are the APIs our team has been working on since November 2019.

We now also pose capabilities to develop a process for custom synthesis for products of the client interest.  We are looking for customers and partners who can utilize our expertise in high vacuum distillation, API with regulatory documents, handling of Hazardous chemicals like Sodium thiomethoxide, and personalized services.

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Viren Patel

Director – Commercial

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Orchev have been an active member for construction of the community centre of Shapar village, where our facility is located. The Modern community centre offers cheap accommodation and highly affordable venue for hosting different occasions ranging from weddings to community gathering. Thus giving support and relief to local families.

Our MD Mr. Bhalodia has always understood the importance of giving back to society by supporting several activities like Earthquake relief work (2001 – Kutch), continuous support to community development work in Rajkot, providing employment and training opportunities to economically backward families, a donation to healthcare sector and many others.

Orchev management always participates in Shapar Industrial Association activities like road construction, sanitization, drinking water and other facilities.

Orchev being one of the very few chemical industry in city, we provide 6 months weekend based industrial training, 1 month industrial training, industrial visit, and know-how, etc. which is part of curriculum of Chemistry and Chemical engineering students.

Every year, we plant several trees in and around our facility.  Our Director Mrs. Kanchan Bhalodia has planted and grown around 750 trees in last 4 years at her Farm.

Repeating almost every year, around 100 new trees are planted on every World Environment Day (5^th  June) in association with neighboring units and Gujarat Pollution control board (Rajkot office) around our factory premises.

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