Naproxen API
CAS Number: 22204-53-1
About Naproxen API
Therapeutic Category
Pain Management
API Technology
Synthetic
Dose Form
Oral Solids
Dr Reddy's Development Status
Available
Available Regulatory Filing
USDMF
Mechanism of Action
Naproxen has analgesic, anti-inflammatory, and antipyretic properties. ANAPROX DS (naproxen sodium) has been developed as a more rapidly absorbed formulation of naproxen for use as an analgesic.
The mechanism of action of naproxen, like that of other NSAIDs, is not completely understood but involves inhibition of cyclooxygenase (COX-1 and COX-2).
Naproxen is a potent inhibitor of prostaglandin synthesis in vitro. Naproxen concentrations reached during therapy have produced in vivo effects. Prostaglandins sensitize afferent nerves and potentiate the action of bradykinin in inducing pain in animal models. Prostaglandins are mediators of inflammation. Because naproxen is an inhibitor of prostaglandin synthesis, its mode of action may be due to a decrease of prostaglandins in peripheral tissues.
Indication
NAPROSYN Tablets, EC-NAPROSYN, and ANAPROX DS are non-steroidal anti-inflammatory drugs indicated for the relief of the signs and symptoms of:
- Rheumatoid arthritis
- Osteoarthritis
- Ankylosing spondylitis
- Polyarticular juvenile idiopathic arthritis
NAPROSYN Tablets and ANAPROX DS are also indicated for the relief of signs and symptoms of:
- Tendonitis
- Bursitis
- Acute gout the manage ment of
- Pain
- Primary dysmenorrhea
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 Naproxen 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 Naproxen 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.
Related Resources
Managing the Product Life Cycle: Naproxen API and formulations
Naproxen is a non-steroidal anti-inflammatory drug (NSAID) used in treating pain, menstrual cramps, and inflammatory diseases such as rheumatoid arthritis and fever.
SustainableSupply Chain
GlobalRegulatory Support
More than one decade of
Naproxen manufacturing> 1500metric tons per year
Trusted byleading pharmacompanies
Naproxen is a non-selective COX inhibitor and appears to exert anti-inflammatory action by reducing the production of inflammatory mediators like prostaglandins.
Naproxen was patented in 1967 and approved for use in the United States in 1976.
Naproxen by Dr. Reddy’s
The manufacturing of Naproxen and Naproxen Sodium has a long tradition at Dr. Reddy’s. We manufacture Naproxen for more than one decade at our cGMP site in Cuernavaca, Mexico. Today we are the 2nd largest manufacturer of Naproxen globally and reliably supply our global pharma customers with APIs and finished formulations.
Active Pharmaceutical Ingredient
- Naproxen Base and Naproxen Na
- Manufactured at our dedicated cGMP facility in Cuernavaca, Mexico
- Total capacity > 1500 MT
- Customized particle size
Finished Dosage Form
- Naproxen Na Rx
- Formulated at our cGMP manufacturing site in Hyderabad, India
Addressing the changing market demands in the product life cycles
Naproxen has become one of the focus products of Dr. Reddy’s and our teams are working on constant improvements an capacity expansion to meet the changing market needs. Some of our approaches include.
- Robust supply chain – most of our key starting materials are now backward integrated and we have diversified our raw material sourcing through long term contracts and sourcing efficiencies to facilitate sustainable supplies.
- Capacity expansion – we have been working consistently over last one year to increase our manufacturing capacity by 50%.
- Continuous improvement – during the API life cycle, we regularly improve process efficiency and quality.
- Product life-cycle management – on request we are able to provide new formulations such as Naproxen Na OTC
- Facilitating formulation needs – on request we are able to supply formulators with DC grade granules of Natproxen Na to facilitate faster formulation development and manufacturing.
Read More
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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.
FAQs
Pain relief from indications such as headache, muscle ache, tendonitis, dental pain, and menstrual cramps. Also reduces swelling, pain, and joint stiffness caused by arthritis, bursitis, and gout attacks.
Adults—550 milligrams (mg) for the first dose, then 550 mg every 12 hours or 275 mg every 6 to 8 hours as needed.
We offer Polymorphic Form-I
Meet with our product experts in one-on-one virtual sessions at https://api.drreddys.com/meet-api-experts or Write to us at api@drreddys.com.
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