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About Esomeprazole Magnesium Trihydrate API

Product
  • Therapeutic CategoryGastro-Intestinal - GI

  • API Technology

    Synthetic

  • Dose Form

    Oral Solid/Capsules, Suspension

  • Dr Reddy's Development Status

    Available (Commercial)

  • Available Regulatory Filing

    USDMF, CEP Submitted, EUDMF, Canada DMF, China DMF, Brazil DMF

Mechanism of Action

Esomeprazole is a proton pump inhibitor that suppresses gastric acid secretion by specific inhibition of the H+/K+-ATPase in the gastric parietal cell. The S-and R-isomers of omeprazole are protonated and converted in the acidic compartment of the parietal cell forming the active inhibitor, the achiral sulphenamide. By acting specifically on the proton pump, esomeprazole blocks the final step in acid production, thus reducing gastric acidity. This effect is dose-related up to a daily dose of 20 to 40 mg and leads to inhibition of gastric acid secretion.

Indication

NEXIUM is a proton pump inhibitor indicated for the following:

  • Treatment of gastroesophageal reflux disease (GERD)
  • Risk reduction of NSAID-associated gastric ulcer.
  • H. pylori eradication to reduce the risk of duodenal ulcer recurrence.
  • Pathological hypersecretory conditions, including Zollinger-Ellison syndrome.

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 Esomeprazole Magnesium Trihydrate 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 Esomeprazole Magnesium Trihydrate 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 Esomeprazole Magnesium Trihydrate API used for
  • Treats GERD, ulcers, and Zollinger-Ellison syndrome

What is the dosage form and strength currently available for Esomeprazole Magnesium Trihydrate?
  • Available as delayed-release capsules (20 mg, 40 mg)

How do you store Esomeprazole Magnesium Trihydrate API?
  • Store at 20°C to 25°C (68°F to 77°F), in a cool, dry place

What food you should avoid when taking Esomeprazole Magnesium Trihydrate?
  • Take on an empty stomach, at least 1 hour before meals

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.