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Rabeprazole Sodium (Amorphous & Form Y)

Rabeprazole Sodium (Amorphous & Form Y) API

Rabeprazole Sodium (Amorphous & Form Y)-API

CAS Number: 117976-90-6

Therapeutic Category
Gastro-Intestinal - GI
API Technology
Synthetic
Dose Form
Oral Solids
Dr Reddy's Development Status
Available
Available Regulatory Filing
USDMF
CEP Granted
Brazil DMF
EUDMF
Canada DMF
Russia DMF
Innovator Brand (USA)
ACIPHEX
Plant
1005(CTO5)

Mechanism of Action

"Rabeprazole belongs to a class of antisecretory compounds (substituted benzimidazole proton-pump inhibitors) that do not exhibit anticholinergic or histamine H2-receptor antagonist properties, but suppress gastric acid secretion by inhibiting the gastric H+, K+ATPase at the secretory surface of the gastric parietal cell. Because this enzyme is regarded as the acid (proton) pump within the parietal cell, rabeprazole has been characterized as a gastric proton-pump inhibitor. Rabeprazole blocks the final step of gastric acid secretion. In gastric parietal cells, rabeprazole is protonated, accumulates, and is transformed to an active sulfenamide. When studied in vitro, rabeprazole is chemically activated at pH 1.2 with a half-life of 78 seconds. It inhibits acid transport in porcine gastric vesicles with a half-life of 90 seconds."

Indication

ACIPHEX delayed-release tablets is a proton pump inhibitor (PPI) indicated in adults for:

  • Healing of Erosive or Ulcerative Gastroesophageal Reflux Disease (GERD)
  • Maintenance of Healing of Erosive or Ulcerative GERD
  • Treatment of Symptomatic GERD
  • Healing of Duodenal Ulcers
  • Helicobacter pylori Eradication to Reduce Risk of Duodenal Ulcer Recurrence
  • Treatment of Pathological Hypersecretory Conditions, Including Zollinger-Ellison Syndrome
    In adolescent patients 12 years of age and older for:
  • Short-term Treatment of Symptomatic GERD

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 Rabeprazole Sodium (Amorphous & Form Y) 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 Rabeprazole Sodium (Amorphous & Form Y) 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.

Gastrointestinal API Products:

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Disclaimer

No information in this catalog - including any reference to any product or service - constitutes an offer for sale, or be construed as representing an offer for sale. Products protected under valid patents are not offered or supplied for commercial use. However, the research quantities of such products may be offered for the purpose of regulatory submissions, wherever such regulatory exemptions exist. The buyers should make their independent evaluation of the patent scenario for their respective markets and will be responsible for all patent related liabilities. Products protected under valid patents in India are not available for commercial use but would be available for Section 107A purposes.