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About Vonoprazan Fumarate API

Product
  • Therapeutic Category胃肠道 – GI

  • API Technology

    Small molecule

  • Dose Form

    Oral Solid/Tablets

  • Dr Reddy's Development Status

    Available (Commercial)

  • Available Regulatory Filing

    USDMF, Brazil DMF

Mechanism of Action

Vonoprazan fumarate is a proton pump inhibitor that works by reducing the amount of acid produced in the stomach. It does this by blocking the activity of the enzyme H+/K+ ATPase, which is responsible for producing gastric acid.

The mechanism of action of vonoprazan fumarate involves the inhibition of the final step of acid secretion, which is the transport of hydrogen ions into the gastric lumen. This leads to a decrease in the production of gastric acid and therefore reduces the amount of acid that is available to cause damage to the esophagus, stomach, or duodenum.

Vonoprazan fumarate has a rapid onset of action and provides sustained acid suppression for 24 hours with a single daily dose, making it an effective treatment for a variety of acid-related conditions such as gastroesophageal reflux disease (GERD), peptic ulcer disease (PUD), and Zollinger-Ellison syndrome.

Indication

Vonoprazan fumarate is indicated for the treatment of various acid-related conditions, including:

Gastroesophageal Reflux Disease (GERD): Vonoprazan fumarate is used to relieve symptoms of GERD, such as heartburn, regurgitation, and chest pain.

Peptic Ulcer Disease (PUD): Vonoprazan fumarate is used to treat PUD, which is caused by the formation of sores or ulcers in the stomach or duodenum.

Zollinger-Ellison Syndrome: Vonoprazan fumarate is used to treat Zollinger-Ellison syndrome, a rare condition in which the stomach produces too much acid.

It is important to note that vonoprazan fumarate should be used only under the supervision of a healthcare provider, and the dose and duration of treatment should be based on the individual's medical condition and response to therapy.

Dr. Reddy's Expertise

Headquartered in Hyderabad, India, Dr. Reddy's Laboratories is one of the leading Active Pharmaceutical Ingredients (API) manufacturers and suppliers globally for Vonoprazan Fumarate API. Dr. Reddy's API business is a preferred partner to pharma companies across the US, Europe, Brazil, Latin America, Japan, China, Korea, Middle East and other emerging markets.

Dr. Reddy's API business thrives on the deep technical strengths established over the last 30+ years in the development and manufacture of complex APIs such as steroids, peptides, complex long chain molecules and highly potent APIs (HPAPIs / oncology drugs). This expertise is complemented by our prowess in intellectual property and regulatory affairs which helps us consistently meet and exceed regulatory standards. Dr. Reddy's Vonoprazan Fumarate API is the outcome of the extensive expertise in R&D, IP, and Regulatory.

A key component in helping our customers be first to market is a responsive supply chain. We achieve this by making sure that all our facilities are operating efficiently and to the latest standards of quality, safety, and productivity. A strong interconnect between business and factories allows for a quick reaction to dynamic market changes, so that we can avert shortages and meet sudden surges in demand.

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FAQs

What is Vonoprazan Fumarate API used for?
  • Treats erosive esophagitis, GERD, and peptic ulcers
    Used with antibiotics for Helicobacter pylori eradication

What is the dosage form and strength currently available for Vonoprazan Fumarate?
  • Available as oral tablets: 10 mg, 20 mg

What are the benefits of Vonoprazan Fumarate API?
  • Potent acid suppression
    Rapid symptom relief
    Effective in H. pylori eradication
     

How do you store Vonoprazan Fumarate API?
  • Store at 20°C to 25°C (68°F to 77°F), protect from moisture and light

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