What is Granules India's Naproxen Sodium API?
Granules India manufactures Naproxen Sodium Active Pharmaceutical Ingredient (API) [1]. Naproxen sodium is a nonsteroidal anti-inflammatory drug (NSAID) used to relieve pain, fever, and inflammation [2].
What makes Granules India's Naproxen Sodium API notable?
Granules India is a significant producer of Naproxen Sodium API, positioning itself as a key supplier in the global market [1]. The company's manufacturing capabilities and quality standards contribute to its standing in the pharmaceutical industry.
How is Naproxen Sodium API regulated?
APIs like Naproxen Sodium are subject to stringent regulatory oversight by health authorities worldwide, such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). Manufacturers must adhere to Good Manufacturing Practices (GMP) to ensure product quality, safety, and efficacy [3].
When does the patent for Naproxen Sodium expire?
Naproxen sodium is a well-established drug, and its primary patents have long expired. This allows for the production of generic versions by multiple manufacturers, including Granules India [4].
Who are Granules India's competitors in Naproxen Sodium API?
The market for Naproxen Sodium API includes various global manufacturers. Companies that also produce naproxen sodium API compete with Granules India. Specific competitor names are not provided in the given information.
What are the applications of Naproxen Sodium?
Naproxen sodium is used to treat a range of conditions characterized by pain and inflammation. This includes symptoms associated with arthritis, such as rheumatoid arthritis and osteoarthritis, as well as menstrual cramps, gout, and general pain relief [2].
What are the potential risks or side effects of Naproxen Sodium?
Like other NSAIDs, naproxen sodium carries potential risks, including gastrointestinal issues such as ulcers and bleeding. Cardiovascular risks and kidney problems can also occur. Patients should use it under the guidance of a healthcare professional to monitor for adverse effects [5].
How does Naproxen Sodium API manufacturing impact drug pricing?
The availability of multiple API manufacturers, like Granules India, and the expiration of patents contribute to competitive pricing for naproxen sodium finished drug products. Generic competition generally leads to lower costs for consumers and healthcare systems [4].
Where can I find more information on drug patents and APIs?
DrugPatentWatch.com provides comprehensive information on drug patents, including patent expiration dates, ANDA filings, and API manufacturers [6].
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Sources:
1. Granules India official website (as cited in provided context, no direct URL given for this specific product information)
2. National Institutes of Health. (n.d.). Naproxen. MedlinePlus. https://medlineplus.gov/druginfo/meds/a681020.html
3. U.S. Food and Drug Administration. (n.d.). Good Manufacturing Practice (GMP). https://www.fda.gov/medical-devices/device-advice-compilations/good-manufacturing-practice-gmp
4. DrugPatentWatch.com (General knowledge about patent expirations for established drugs).
5. Mayo Clinic. (n.d.). Naproxen (Oral Route). https://www.mayoclinic.org/drugs-supplements/naproxen-oral-route/side-effects/drg-20071309
6. DrugPatentWatch.com. https://drugpatentwatch.com/