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About Naproxen API

Product
  • Therapeutic CategoryPain Management

  • 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

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 ChainGlobalRegulatory SupportMore than one decade ofNaproxen manufacturing> 1500metric tons per yearTrusted byleading pharmacompaniesNaproxen 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’sThe 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 IngredientNaproxen Base and Naproxen NaManufactured at our dedicated cGMP facility in Cuernavaca, MexicoTotal capacity > 1500 MTCustomized particle sizeFinished Dosage FormNaproxen Na RxFormulated at our cGMP manufacturing site in Hyderabad, IndiaAddressing the changing market demands in the product life cyclesNaproxen 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 OTCFacilitating formulation needs – on request we are able to supply formulators with DC grade granules of Natproxen Na to facilitate faster formulation development and manufacturing.
Disclaimer: Products under patent(s) are offered only for R&D purposes U/S 107A of the Patent Act (Bolar Exemption) and not for commercial sale.