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About Nizatidine API

Product
  • Therapeutic CategoryGastro-Intestinal – GI

  • API Technology

    Synthetic

  • Dose Form

    Oral Solid/Capsules

  • Dr Reddy's Development Status

    Available (Commercial)

  • Available Regulatory Filing

    USDMF, CEP Submitted, Japan DMF, Korea DMF

Mechanism of Action

Nizatidine competes with histamine for binding at the H2-receptors on the gastric basolateral membrane of parietal cells. Competitive inhibition results in reduction of basal and nocturnal gastric acid secretions. The drug also decreases the gastric acid response to stimuli such as food, caffeine, insulin, betazole, or pentagastrin.

Indication

For the treatment of acid-reflux disorders (GERD), peptic ulcer disease, active benign gastric ulcer, and active duodenal ulcer.

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 Nizatidine 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 Nizatidine 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.

RFQ Form

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Related Resources

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FAQs

What drug class is nizatidine API ?
  • Nizatidine belongs to a class of drugs known as H2 blockers.

What is main purpose of using the nizatidine API ?
  • Inhibits stomach acid production, and is commonly used in the treatment of peptic ulcer disease and gastroesophageal reflux disease.

What is the safety guide for nizatidine API ?
  • Duodenal & Gastric Ulcer, Erosive Esophagitis and Gastroesophageal Reflux Disease- 300 mg orally (150mg twice).

What are Dr.Reddy's Offerings for Nizatidine API ?
  • We offer Crystalline form (No specific Polymorphic Form is claimed).

What is the process available for ordering nizatidine API ?
Disclaimer: Products under patent(s) are offered only for R&D purposes U/S 107A of the Patent Act (Bolar Exemption) and not for commercial sale.