溴芬酸

Ocular inflammation and postoperative pain are common clinical treatment needs in ophthalmology. Non-steroidal anti-inflammatory drugs (NSAIDs) have become the mainstream medication choice for such conditions due to their advantage of no hormone-related adverse reactions. Bromfenac is an arylpropionic acid class of NSAID, which reduces prostaglandin production by potently inhibiting the cyclooxygenase (COX) pathway, and its anti-inflammatory activity is 10 times that of diclofenac and 3 times that of ketorolac. Clinically, it is mainly used to treat ocular inflammations such as conjunctivitis and scleritis, as well as to relieve pain and inflammation after ophthalmic surgeries including cataract and glaucoma surgeries. It is suitable for adult and adolescent patients over 12 years old, with fast onset of effect after local administration and good ocular tolerance.

The global bromfenac market size was approximately USD 870 million in 2023, with a compound annual growth rate (CAGR) of 7.2% from 2019 to 2023. The growth momentum mainly comes from the increase in the volume of ophthalmic surgeries and the expansion of indications for dry eye disease accompanied by inflammation. The terminal sales of bromfenac in the Chinese market exceeded RMB 1.2 billion in 2023, with a CAGR of over 11% in the recent three years. At present, the domestic preparation market is dominated by the original research product, with fewer than 10 enterprises having received approval for generic drugs, and the number of manufacturers with mature and compliant qualifications on the API supply side is limited, so there is still a market gap.

The original research enterprise of bromfenac is Senju Pharmaceutical Co., Ltd. of Japan, with the original brand name "Pranopulin". Its Chinese compound patent expired in 2021. The main formulation approved for the original product is 0.1% bromfenac sodium hydrate eye drops, with a conventional specification of 5ml:5mg. It has been included in the *Catalogue of Reference Preparations of Chemical Drugs* issued by China NMPA, and is also listed in the FDA Reference Preparations Catalogue. According to the domestic API registration platform, nearly 10 enterprises have obtained A-status registration numbers for bromfenac APIs, and more than 8 domestic enterprises have received approval for bromfenac sodium eye drops. (Data as of June 2025, please refer to the official CDE website for the latest information)

CATO can provide a full set of bromfenac impurity reference standards, most of which are in stock. For in-stock products, orders placed before 16:00 will be shipped on the same day. All products fully comply with the regulatory requirements of the Chinese Pharmacopoeia, FDA and other regulations, and can provide stable reference standard support for the whole process of API R&D, quality research and declaration.