– 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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Active Pharmaceutical Ingredients

Other Products

• Sodium methyl mercaptide – CAS # 5188-07-8
• Sodium thiomethoxide – CAS No. 5188-07-8
• Sodium methylthiolate – CAS # 5188-07-8
• Methyl Mercaptan Sodium Salt – CAS # 5188-07-8
• Sodium Methanethiolate CAS No. 5188-07-8
• 1-methylthio-2-propanone – CAS # 14109-72-9
• 3-Bromothioanisole  – CAS # 33733-73-2

Custom Manufacturing

Based on long term agreements, we are serving some prestigious clients for both contract manufacturing and Custom Manufacturing.

What makes ORCHEV the ideal choice for Custom Manufacturing is our US-FDA/EU-GMP approved facility and small team, whereby we are able to provide personalized attention on the smallest requirement of customers, ensuring credible analytical results and high quality & GMP norms.  If the process is not available with the customer, we have been able to develop our manufacturing process quickly to ensure the fastest supply to clients.

Our US-FDA and EDQM approved site is available for API and intermediate contract manufacturing.

> Concentration Range: 10% to 97% Purity > Production Capacity: Over 55 Metric Tons (MT) per month.

OLED

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