Name: Famotidine IP/BP
Brand: OREX PHARMA PVT. LTD

08045815720

OREX PHARMA PVT. LTD
GST : 27AAACO0984E1ZJ

Product Details:

Color White to off-white
Solubility Slightly soluble in water, insoluble in ethanol and ether
Structural Formula (see image, contains a substituted thiazole ring connected to a sulfamoylpropamidine moiety)
Boiling point Not applicable (decomposes before boiling)
Shelf Life 5 years
Storage Store in a tightly closed container, protected from light and moisture
Molecular Weight 337.45 g/mol
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Famotidine IP/BP Price And Quantity

Minimum Order Quantity 100 Kilograms

Famotidine IP/BP Product Specifications

Chemical Name 3-[[[2-[(diamino-methyleneamino)thiazol-4-yl]methyl]thio]ethyl]thio]-N-sulfamoylpropanimidamide
Purity(%) 99%
Ph Level Neutral to slightly basic
Medicine Name Famotidine IP/BP
Particle Size Typically micronized/powdered form
Molecular Formula C8H15N7O2S3
Smell Odorless
Heavy Metal (%) NMT 0.001%
Melting Point ~163-167C
Poisonous Non-poisonous in therapeutic doses
Loss on Drying NMT 0.5%
Grade IP/BP
Storage Store in a tightly closed container, protected from light and moisture
Boiling point Not applicable (decomposes before boiling)
Shelf Life 5 years
Type API (Active Pharmaceutical Ingredient)
CAS No 76824-35-6
Physical Form Solid
Solubility Slightly soluble in water, insoluble in ethanol and ether
Appearance White to off-white crystalline powder
Color White to off-white
Structural Formula (see image, contains a substituted thiazole ring connected to a sulfamoylpropamidine moiety)
Usage Treatment of ulcers, gastroesophageal reflux disease (GERD), and conditions causing excessive stomach acid
HS Code 29349900
Molecular Weight 337.45 g/mol

Formulation Support Suitable for formulation of tablets and syrups
USP Reference USP-Famotidine
Microbial Limit Total aerobic microbial count: NMT 1000 cfu/g, Total yeast & mold count: NMT 100 cfu/g
Stability Stable under recommended storage conditions
Pharmacopoeial Compliance IP/BP/USP/EP
Packaging HDPE drums with double polyethylene bags, 25kg net weight
Related Substances NMT 0.5%
Identification IR & HPLC conforms to standard
pKa 7.1
Residue on Ignition NMT 0.1%
Packing Type Export worthy, as per customer requirement

Famotidine IP/BP Trade Information

Payment Terms Cash in Advance (CID)
Supply Ability 5000 Kilograms Per Month
Delivery Time 10 Days
Main Domestic Market All India

Product Description

Famotidine IP/BP is a medicine which is prescribed for stomach ulcers & intestine for the treatment of erosive esophagitis, gastroesophageal reflux disease, and Zollinger-Ellison Syndrome. It is a type of antihistamine that blocks the release of stomach acid. It is formulated by our professionals using exceptional grade ingredients that are procured from established vendors of the market. We provide this Famotidine IP/BP as per the requirement by our customers.

Pharmacopoeial-Grade Quality and Safety

Famotidine IP/BP features exceptional purity (99%) and complies with multiple pharmacopoeial standards (IP/BP/USP/EP), ensuring high safety and efficacy in pharmaceutical formulations. Each batch is meticulously analyzed for identity, impurities, and microbial limits, supporting reliable performance and regulatory acceptance for global markets.

Robust Packaging for Export and Storage

Delivered in 25kg net weight HDPE drums lined with double polyethylene bags, Famotidine is securely packaged to maintain stability and prevent contamination. The packaging is tailored to withstand international shipping and customizable according to specific customer requirements, ensuring product integrity throughout transport and storage.

FAQ's of Famotidine IP/BP:

Q: How is Famotidine IP/BP typically used in pharmaceutical formulations?

A: Famotidine IP/BP is primarily incorporated into the formulation of tablets and syrups for the treatment of ulcers, GERD, and other acid-related gastrointestinal disorders, owing to its superior purity and proven stability.

Q: What are the key quality specifications for Famotidine IP/BP?

A: This API meets rigorous standards, including a residue on ignition of NMT 0.1%, related substances NMT 0.5%, total aerobic microbial count NMT 1000 cfu/g, and more, with testing methods such as IR and HPLC confirming identity and purity.

Q: When and how should Famotidine IP/BP be stored for optimal shelf life?

A: Famotidine should be stored in tightly closed containers, protected from light and moisture, to ensure maximum stability and preserve its five-year shelf life.

Q: Where is Famotidine IP/BP manufactured and supplied from?

A: Famotidine IP/BP is manufactured, exported, and supplied from India by certified pharmaceutical companies adhering to international standards for APIs.

Q: What is the process for ensuring compliance with pharmacopoeial standards?

A: Manufacturers follow strict processes including identification by IR/HPLC, testing for limits on impurities, microbial counts, and heavy metals, all confirmed against IP/BP/USP/EP requirements to guarantee compliance and quality.

Q: Can Famotidine IP/BP packaging be customized for export?

A: Yes, packaging can be adjusted to meet customer requirements, with standard packaging being export-worthy HDPE drums equipped with double polyethylene liners for enhanced safety during transportation.

Q: What are the benefits of using Famotidine IP/BP from an accredited supplier?

A: Utilizing Famotidine IP/BP from an accredited supplier ensures high product purity, regulatory compliance, robust stability, and reliable supply, all critical for consistent and efficacious finished dosage forms.

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Contact Details

OREX PHARMA PVT. LTD
GST : 27AAACO0984E1ZJ

Pisal House, Stadium Road, Near CIDCO Bus StandThane - 400601, Maharashtra, India

Phone :08045815720

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