PipelinePharma Logo

rebamipide Tablets, film coated 100 mg

Dossier type
CTD
Dossier status
Ready to file
Country of origin
India
GMP approvals
PICS
Manufacturer #31069

Established in 1981, this manufacturer specializes in developing, manufacturing, and marketing a diverse range of pharmaceutical products. As a CTD dossier owner and manufacturer, it holds GMP certifications from international regulatory authorities, including EU-GMP, WHO-cGMP, and approvals from Kenya and Uganda, ensuring compliance with stringent quality standards. The company operates two state-of-the-art manufacturing facilities, producing over 170 products across various therapeutic segments such as anti-hypertensives, anti-diabetics, lipid-lowering agents, anti-infectives, antibiotics, respiratory management, hematinics, anti-allergics, steroids, psychotropics, and vitamin supplements. As a CTD dossier owner and manufacturer, its products are distributed across multiple countries worldwide. With a dedicated R&D center recognized by the DSIR (Government of India), the manufacturer focuses on providing quality medicines with improved patient compliance through novel drug delivery systems.

 

Rebamipide

Rebamipide is an amino acid derivative of 2-(1H)-quinolinone. It is used for mucosal protection, healing of gastroduodenal ulcers, treatment of gastritis, Gastrointestinal ulcers, Dry eyes, peptic ulcer disease, and mouth ulcers. It is a mucosal protective agent. Rebamipide can also limit the damaging effects of NSAIDs on the GIT mucosa, the small intestine, however, it is not used for naproxen-induced gastric damage. Rebamipide accelerates and improves the quality of ulcer healing and reduces ulcer recurrence rate. Rebamipide is sold in Asian countries including Japan, South Korea, China, India, and Russia under the brand names Mucosta, Rebagen, Rebagit among others. Otsuka Pharmaceutical Co Ltd filed for the first patent for Rebamipide in 1983 and later renewed it in 2005, granted in 2010. In 2002, Hanmi Pharm Co Ltd filed for a different patent for an improved method for the preparation of Rebamipide. It is yet to approved by USFDA for sales in the USA.

Dosage and administration

Rebamipide is sold as a tablet. In the treatment of Gastric Mucosal Lesions, which includes Erosion, Bleeding, Redness, and Edema in Acute Gastritis and Acute Exacerbation of Chronic Gastritis among adults, the recommended Usual Dose is 1 tab, taken orally, three times a day. In the treatment of Gastric Ulcers, the recommended Usual adult Dose is one tablet, taken orally, three times a day.

The Price of Rebamipide

In Japan, the consumers have to pay USD 39, for a supply of 14 tablets of 100mg strength. In India, the consumer pays USD 1 for a supply of 10 tablets of 100mg.

How does it work?

Rebamipide actions increase prostaglandin synthesis, which improves the healing of the ulcer. In actions enhance mucosal defense, scavenge free radicals, and temporarily activate genes encoding cyclooxygenase-2. In the replacement of lost tissue, it works by increasing the expression of EGF and its receptors, through which it exerts angiogenesis. This increases the production of granulation tissue and epithelization of ulcer healing. Its key properties include stimulating the prostaglandin and mucus glycoprotein synthesis, inhibiting reactive oxygen species, inflammatory cytokines and chemokines, and inhibition of neutrophils activation. It has also been shown effective against gastric cancer growth, slowing it down.

Finding Rebamipide Manufacturers and Suppliers:

The process of finding trusted Rebamipide manufacturers and Rebamipide suppliers can be made quicker and more accessible by using Pipelinepharma's online platform, a B2B marketplace that lets you finalize the deals of pharmaceutical products in a matter of a few clicks. In addition, it is an easy to use online platform to grow your business opportunities. The robust search engine makes it convenient to search for manufacturers and suppliers of Rebamipide. The search can be further refined with industry-specific filters such as dossier type, country of origin, GMP approvals, and search criteria for Wholesaler, etc. helping to get in contact with the preferred manufacturer and supplier readily.