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About Ranbaxy
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Ranbaxy Established 1937
A List of Drugs Manufactured at the Dewas and Paonta Sahib Facilities
of Ranbaxy Laboratories, Ltd. (Revised September 24, 2008)
FDA has inspected those facilities and, to date, they have met U.S. cGMP requirements for drug manufacturing.
(Good Manufacturing Practice (cGMP)
Ranbaxy is to provide value through pioneering work, research & development and
quality pharmaceuticals across the globe.
Products
Using the finest R&D and Manufacturing facilities, Ranbaxy Laboratories Limited manufacture and markets generic pharmaceuticals, value added generic pharmaceuticals, branded generics, active Pharmaceuticals (API) and intermediates.
The Company remains focused on ascending the value chain in the marketing of pharmaceutical substances and is determined to bring in increased revenues from dosage forms sales.
Ranbaxy's diverse product basket of over 5,000 SKUs available in over 125 countries worldwide, encompasses a wide therapeutic mix covering a majority of the chronic and acute segments. Healthcare trends project that the chronic treatment segments will outpace the acute treatment segments, primarily driven by a growing aging population and dominance of lifestyle diseases. Our robust performance in
Cardiovasculars, Central Nervous System, Respiratory, Dermatology, Orthopedics, Nutritionals and Urology segments, clearly indicates that the Company has strengthened its presence in the fast-growing chronic and lifestyle disease segments. Ranbaxy's top 20 products, ranging from
Anti-infectives to Dermatologicals, account for revenues of over US $ 600 Mn.
Acyclovir
Amoxicillin
Amoxicillin and Clavulanate Potassium
Carbidopa and Levodopa
Cefaclor
Cefadroxil
Cefpodoxime Proxetil
Cefprozil
Cefuroxime Axetil
Cephalexin
Ciprofloxacin HCl
Clarithromycin
Fenofibrate
Fluconazole
Fosinopril Sodium
Fosinopril Sodium and Hydrochlorothiazide
Gabapentin
Ganciclovir Sodium *
Glimepiride
Isotretinoin
Loratadine (OTC)
Metformin HCl
Nefazodone HCl
Nitrofurantoin; Nitrofurantoin and Macrocrystalline
Ofloxacin
Pravastatin Sodium
Ranitidine
Terazosin HCl
Valacyclovir HCl
Zidovudine
RANBAXY TO MARKET US FDA APPROVED DRUG, FOR TREATMENT OF BRAIN TUMOR, IN INDIA
Signs exclusive Licensing agreement with BioPro Pharmaceutical, Inc., USA
Gurgaon (Haryana), India, December 3, 2008: Ranbaxy Laboratories Limited (Ranbaxy) today announced that the Company has received import permission for marketing the US FDA approved product
GLIADEL® (polifeprosan 20 with carmustine implant) Wafer for the treatment of newly diagnosed high-grade malignant gliomas & recurrent glioblastoma
multiforme. Ranbaxy has signed an exclusive licensing agreement with BioPro Pharmaceutical, Inc.,
(BioPro) USA to promote and market Gliadel® Wafer in India.
Commenting on the development, Mr. Sanjeev I. Dani, Senior Vice President & Regional Director, Asia & CIS, Ranbaxy said, "We are pleased to bring this lifesaving, high technology product to Indian patients. We are working with BioPro to create a productive relationship by complementing each other’s strengths. The licensing agreement, and subsequent launch approval, should enable Ranbaxy to further strengthen its position in the Oncology Segment.”
“We are pleased with the professional and rapid processing of our regulatory application of
Gliadel® by the Drug Controller General India’s Office,” reported Peter Huang, Chairman and CEO of
BioPro. “We have an excellent product in Gliadel® and excellent partners in Eisai Inc. and Ranbaxy India. Now, so many brain cancer patients in India will have access to an excellent therapy option.”
Gliadel® Wafer is indicated in newly diagnosed patients with high-grade malignant glioma as an adjunct to surgery and radiation. It is also indicated in recurrent glioblastoma multiforme patients as an adjunct to surgery.
Gliadel® is the only FDA-approved chemotherapeutic implant for use during surgical resection, providing localized delivery of chemotherapy directly into the cavity created when a brain tumor is removed during surgery.
Gliadel® is an off-white to pale yellow, roughly dime-sized wafer made up of a biocompatible polymer that contains the chemotherapeutic drug, carmustine
(BCNU). After a neurosurgeon removes a high-grade malignant glioma, up to eight wafers are implanted along the walls and floor of the cavity where the tumor was previously located. Once implanted,
Gliadel® slowly dissolves, releasing high concentrations of BCNU into the tumor site, which minimizes drug exposure to other areas of the body.
The product is manufactured by MGI Pharma and BioPro retains the marketing rights in some Asian countries including China, Hong Kong, Taiwan, Korea, Singapore, Indonesia, the Philippines, Malaysia, Thailand, and India.
Gliadel® is approved in a number of countries globally including USA, many countries of Europe, Australia, Canada, South Africa, Israel, Korea, Taiwan, Hong Kong, Singapore, Malaysia and Thailand.
Though there is very limited data available on the incidence of brain tumors in India, according to unofficial sources, the estimated prevalence of CNS tumors in India is 2-5 new cases per 100000 per year. Another source estimates the total number of cases to be around 21,000 per year. Glioblastoma multiforme constitutes about 60-65% of these primary brain tumors.
BioPro Pharmaceutical is an oncology specialty biopharmaceutical company focused on the commercialization of products in the Pan Asian pharmaceutical markets. BioPro Pharmaceutical has subsidiary operations in greater China, including Beijing, Hong Kong and Taipei, as well as in Korea and works closely with Distributors in Southeast Asia. The company’s expertise is in providing creative pharmaceutical solutions to US and European companies, simultaneously addressing the pharmaceutical needs of the Asia region. BioPro Pharmaceutical combines its expertise in the development and commercialization of innovative drug therapies with many years successful experience in the promotion, sales and marketing of pharmaceutical products in Asia.
Ranbaxy Laboratories Limited, India's largest pharmaceutical company, is an integrated, research based, international pharmaceutical company producing a wide range of quality, affordable generic medicines, trusted by healthcare professionals and patients across geographies. Ranbaxy’s continued focus on R&D has resulted in several approvals in developed markets and significant progress in New Drug Discovery Research. The Company’s foray into Novel Drug Delivery Systems has led to proprietary "platform technologies," resulting in a number of products under development. The Company is serving its customers in over 125 countries and has an expanding international portfolio of affiliates, joint ventures and alliances, ground operations in 49 countries and manufacturing operations in 11 countries.
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