Pranoprofen

The anti-inflammatory and analgesic value of non-steroidal anti-inflammatory drugs has been widely recognized in ophthalmic clinical practice. Compared with steroidal drugs, they have the advantage of no hormone-related adverse reactions, which makes them more suitable for long-term or high-frequency use scenarios. As a representative variety of propionic acid non-steroidal anti-inflammatory drugs, pranoprofen reduces the biosynthesis of prostaglandins by inhibiting the activity of cyclooxygenase, and meanwhile stabilizes the cell membrane to exert triple effects of anti-inflammation, analgesia and antipyresis. At present, it is mainly used clinically for the symptomatic treatment of external eye and anterior segment inflammation, covering a variety of indications such as blepharitis, conjunctivitis, keratitis, scleritis and postoperative inflammation. The applicable population covers adult patients and children groups whose benefits are greater than risks after clinical evaluation, and it is a common basic drug for ophthalmic anti-inflammatory treatment.

The global market size of ophthalmic anti-inflammatory drugs maintains a steady growth trend. With clear clinical benefits, pranoprofen occupies the core track of non-steroidal anti-inflammatory ophthalmic drugs. In 2023, the sales volume of pranoprofen preparations at the terminals of domestic public medical institutions exceeded 1.4 billion yuan, with a compound growth rate of 7.2% in the past three years. At present, the domestic preparation market presents a competitive pattern of coexistence of original research and generic drugs. More than 10 enterprises have had their generic preparations passed the consistency evaluation. As the volume-based procurement policy extends to the field of specialty drugs, the demand of downstream preparation enterprises for high-quality and cost-effective APIs continues to rise, and the stability of upstream supply chains has become one of the core competitiveness of enterprises.

The original research enterprise of pranoprofen is Senju Pharmaceutical Co., Ltd. (Japan), with the original brand name of Pranopulin. The core compound patent expired in 2011. At present, the mainstream dosage form approved for the original research is ophthalmic preparation, with the specification of 0.1% (5ml:5mg). The original ophthalmic preparation has been included in the Catalogue of Marketed Drugs in China as a reference preparation. According to the data of the domestic API registration platform, more than 15 enterprises have obtained A-status registration numbers for their pranoprofen APIs, and more than 30 varieties of domestic pranoprofen eye drops have been approved, which can fully meet the domestic clinical drug demand. (Data as of October 2024, please refer to the official website of CDE for the latest information)

In response to the demand for impurity reference substances in the whole process of pranoprofen from process research and development to quality control, CATO can provide a full set of impurity reference standards for this API. Most products are in stock, and orders for in-stock products placed before 16:00 will be shipped on the same day. All reference substances comply with the regulatory requirements of the Chinese Pharmacopoeia, FDA and other regulations, and can directly support enterprises' method verification, stability research and registration declaration work.