This CTD dossier owner and manufacturer boasts a strong track record spanning several decades, with a focus on developing innovative products for various markets. Operating in North America, Europe, the Middle East, Africa, and Asia-Pacific, they demonstrate a global presence. Their key product lines include prescription and over-the-counter medications, medical devices, and food supplements. While they have expertise in numerous therapeutic areas, their current focus is on nasal comfort, joint health, and dry mouth solutions. This company embraces a lean and agile approach, prioritizing customer needs and developing new solutions in partnership with a sister company. They maintain a robust network of partners and boast EU and US GMP-compliant production lines. While specific patent information is not readily available, their commitment to innovation and development speaks volumes about their dedication to producing high-quality products.
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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.
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