About Naproxen API
Therapeutic CategoryTratamiento del dolor
CAS Number
22204-53-1
API Technology
Synthetic
Dose Form
Suspension, Tablets
Dr Reddy's Development Status
Available
Available Regulatory Filing
USDMF, CEP Submitted, Brazil DMF, Canada DMF, Japan DMF, Korea DMF, Russia DMF, China DMF
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
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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.
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.
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Adults—550 milligrams (mg) for the first dose, then 550 mg every 12 hours or 275 mg every 6 to 8 hours as needed.
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We offer Polymorphic Form-I
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Meet with our product experts in one-on-one virtual sessions at https://api.drreddys.com/meet-api-experts or Write to us at [email protected].
Descargo de responsabilidad
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