Vonoprazan API Manufacturers and Suppliers in India

Vonoprazan

Vonoprazan is used in form of the fumarate for the treatment of gastroduodenal ulcer (including some drug-induced peptic ulcers) and reflux esophagitis, and can be combined with antibiotics for the eradication of Helicobacter pylori.

Description

Name of the product: Vonoprazan API

Chemical Name : (S)-5-chloro-N-{[2-oxo-3-[4-(3-oxomorpholin-4-yl)phenyl]oxazolidin-5-yl]methyl}thiophene-2-carboxamide

Molecular weight: 461.46 g/mol

Molecular formula: C17H16FN3O2S

Category: Potassium-Competitive Acid Blocker (PCAB)

Therapeutic use:  Treatment of acid-related gastrointestinal disorders like GERD and ulcers.

Usage:  
☐ Dosage forms: Tablets or other suitable formulations.
☐ Administration: Oral.

Physical Form: Crystalline powder

Color: White to nearly white

Size of package: As per requirement

Synonyms: 1-[5-(2-fluorophenyl)-1-pyridin-3-ylsulfonylpyrrol-3-yl]-N-methylmethanamine, TAK-438

Solubility: Soluble in dimethyl sulfoxide, but has limited solubility in N,N-dimethylacetamide, N,N-dimethylformamide, methanol, and water
Melting point: 194.8 deg C

Vonoprazan API in Pharmaceutical

Vonoprazan Fumarate API is used mainly to cure gastroesophageal reflux disease and other forms of digestive disorders such as peptic ulcer disease, and zollinger-ellison syndrome. It is a proton pump inhibitor that functions by reducing the amount of acid generated in the stomach. Bio-synth is one of the leading suppliers of Vonoprazan in India, with a capacity to supply 750 kg/month. Bio-synth manufactures both intermediates of Vonoprazan, namely Pyridine 3-sulfonyl chloride and 5-(2-fluorophenyl)-1h-pyrrole-3-carbaldehyde, thereby assuring high quality and competitive prices.

Vonoprazan API Specification

The above mentioned Vonoprazan API specifications ensure that each batch of Vonoprazan meets global quality standards. As one of the top Vonoprazan API manufacturers in India, Bio-Synth adheres to strict guidelines to ensure product purity and properties. Bio-synth also manufactures the intermediates of Vonoprazan with the following specifications:

  1. Pyridine-3-sulfonyl chloride: Purity- not less than 99.0%; Total impurities- Not more than 1.0%; Unspecified impurity- Not more than 0.5%
  2. 5-(2-fluorophenyl)-1h-pyrrole-3-carbaldehyde: Purity- not less than 95.0%; Total impurities- Not more than 1.0%

Quality Standards and Manufacturing Excellence of Bio-Synth

Bio-Synth operates with an unwavering commitment to quality. Our manufacturing processes integrate:

☐ WHO-GMP (Good Manufacturing Practices) compliance

☐ ISO 9000:2015 certification

☐ Adherence to ICH guidelines and pharmacopeia standards 

Our facilities are equipped with cutting-edge technology and maintain strict adherence to GLP (Good Laboratory Practices), GDP (Good Documentation Practices), and cGMP (Current Good Manufacturing Practices). This results in consistent product quality, reinforcing Bio-Synth’s reputation for excellence.

Applications of Vonoprazan API

Vonoprazan is used to heal and maintain healing of erosive esophagitis (inflammation that causes damage to the tube that runs from the throat to the stomach) and help lessen symptoms of heartburn associated with erosive esophagitis in adults. Vonoprazan is also used in combination with clarithromycin and/or amoxicillin to eliminate Helicobacter pylori, a type of bacteria that causes ulcers (sores in the lining of the stomach or intestine).

Therapeutic Uses and Indications

Vonoprazan is in a class of medications called potassium-competitive acid blockers (PCAB). It works by decreasing the amount of acid made in the stomach. Vonoprazan API is used to treat GERD, peptic ulcers, H. pylori infection, Zollinger-Ellison syndrome, and NSAID-induced gastric damage, offering effective acid suppression.

How Vonoprazan API Works (Mechanism of Action)

Vonoprazan inhibits the gastric proton pump, also known as the H+, K+-ATPase enzyme, by reversibly binding to it. This reversible binding allows vonoprazan to act more quickly and maintain acid suppression longer than proton pump inhibitors (PPIs)

Why Choose Bio-Synth for Vonoprazan API

Bio-Synth adheres to stringent quality protocols to ensure that each batch of Vonoprazan meets comprehensive global quality standards. Our robust quality control practices confirm the purity, potency, and safety of our products, ensuring reliable therapeutic results. Our 120kL WHO-GMP, ISO certified facility has a capacity to manufacture 0.75 MT of Vonoprazan per month. Bio-synth manufacturers all intermediates of Vonoprazan in-house, ensuring superior quality, price, and delivery schedules. With over 8 decades of experience in the international and domestic markets, Bio-synth is one of the most trusted and reputed API manufacturers.

Advantages and Key Features of Vonoprazan API

1. Acid suppression: Vonoprazan is more potent than PPIs at suppressing acid secretion, especially at night. It also has a longer half-life than PPIs, allowing for once-daily dosing.
2. Rapid onset: Vonoprazan starts working quickly and has a rapid onset of action.
3. Stability: Vonoprazan is stable in acidic environments and gastric juice.
4. Safety: Vonoprazan has a comparable or better safety profile than PPIs, with fewer drug interactions.
5. Efficacy: Vonoprazan is effective in treating a variety of acid-related diseases, including GERD, PUD, and H. pylori infection.
6. Long-lasting: Vonoprazan’s effects are long-lasting, and it can suppress both active and inactive proton pumps.
7. No hepatic toxicity: Vonoprazan doesn’t have the hepatic toxicity that some previous P-CABs have.
8. Independent of CYP2C19: Vonoprazan undergoes metabolic elimination independently of cytochrome P450 (CYP) 2C19 polymorphism.

Vonoprazan API Suppliers and Manufacturers in India

With 81 years of experience manufacturing APIs and intermediates, Bio-synth supplies high-quality products in India and internationally. Bio-Synth adheres to stringent quality protocols to ensure that each batch of Vonoprazan meets comprehensive global quality standards. Our robust quality control practices confirm the purity, potency, and safety of our products, ensuring reliable therapeutic results. Bio-synth manufacturers all intermediates of Vonoprazan in-house, ensuring superior quality, price and delivery schedules.

Vonoprazan API Price in India

We provide highly competitive pricing designed to meet your bulk order needs, ensuring exceptional value for your investment. Our pricing structure is flexible and can be customized to align with your specific requirements. For a personalized quote or to discuss pricing options, feel free to get in touch with us today.

Frequently asked questions

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    Vonoprazan API is the active pharmaceutical ingredient used in medications to treat acid-related disorders like GERD and peptic ulcers, acting as a potassium-competitive acid blocker (P-CAB) to reduce stomach acid production

    Vonoprazan is used in form of the fumarate for the treatment of gastroduodenal ulcer (including some drug-induced peptic ulcers) and reflux esophagitis, and can be combined with antibiotics for the eradication of Helicobacter pylori.

    Bio-synth is one of the leading manufacturers of Vonoprazan and its intermediates. Bio-synth has more than 80 decades of experience manufacturing APIs for the global and domestic markets.

    Bio-Synth stands out as a trusted Vonoprazan API manufacturer in India due to its strict adherence to global standards, such as WHO-GMP and ISO 9000:2015 certifications. We focus on high-quality, reliable production, offering competitive pricing and customizable solutions. Our robust quality control and consistent supply make Bio-Synth a dependable partner for pharmaceutical companies needing top-quality Vonoprazan API

    Bio-synth is one of the leading manufacturers of Vonoprazan in India. Please reach out with your bulk order needs to avail high quality product at competitive prices

    Our facilities are equipped with cutting-edge technology and maintain strict adherence to GLP (Good Laboratory Practices), GDP (Good Documentation Practices), and cGMP (Current Good Manufacturing Practices). This results in consistent product quality, reinforcing Bio-Synth’s reputation for excellence.

    To place an order for Vonoprazan API, contact Bio-Synth through the provided customer service details or fill out the contact form for sample requests and further information. We are one of the leading Vonoprazanl API manufacturers in India and ensure timely delivery to meet your needs.

    Delivery time will depend on required quantity and specifications. Please reach out via the provided customer service details to learn more.

    Vonoprazan API intermediate is a precursor compound used in the synthesis of Vonoprazan, an acid-suppressing drug. It plays a crucial role in the production of the final therapeutic product.

    India offers competitive pricing, high-quality standards, and reliable supply chain management. We provide essential raw materials for the production of Vonoprazan in the pharmaceutical industry.