Qilu Pharmaceutical's Pranoprofen Eye Drops Approved for Market Launch with Consistency Evaluation

Recently, Pranoprofen Eye Drops by Qilu Pharmaceutical Co., Ltd. has been approved by the National Medical Products Administration (NMPA) and is deemed to have passed the consistency evaluation. So far, Qilu Pharmaceutical has a total of 141 products that have passed the consistency evaluation, 54 of which are the first in China.

Ophthalmic inflammation mainly includes conjunctivitis, keratitis, uveitis, etc., with clinical manifestations such as a foreign body sensation, tearing, pain, and decreased vision. As people increasingly use electronic products like mobile phones and computers, the incidence of ocular inflammation caused by overuse of the eyes is also on the rise, making the treatment of ocular inflammation more important.

Pranoprofen is a non-steroidal anti-inflammatory drug that can block the synthesis of prostaglandins, with effects such as anti-inflammation, anti-allergy, and pain relief. It has fewer adverse reactions and is clinically safer than glucocorticoids. Its local application can prevent and treat various inflammation-related diseases caused by different reasons. Pranoprofen eye drops are suitable for symptomatic treatment of external ocular and anterior segment inflammations (blepharitis, conjunctivitis, keratitis, scleritis, episcleritis, iridocyclitis, postoperative inflammation). Due to its good efficacy and fewer adverse reactions, it has become a fundamental drug for treating ocular inflammation and relieving ocular pain.

In 2018, Qilu Pharmaceutical officially launched the research on Pranoprofen Eye Drops. Guided by the R&D concept of "quality by design," the researchers conducted comprehensive process studies and quality comparisons between the self-made product and the reference preparation, fully ensuring that the self-made product is equivalent in quality and consistent in clinical efficacy to the reference preparation. The production process of Pranoprofen Eye Drops is stable and controllable, utilizing imported precision filling equipment for accurate volume measurement, and passing micro-leakage seal testing to better ensure the product’s safety and sterility. The market launch of this product will provide a new domestically produced medication option for the clinical treatment of patients with ocular inflammation.

At present, the ophthalmic drugs of Qilu Pharmaceutical have covered major treatment areas such as ocular anti-infection, ocular inflammation, glaucoma, anti-allergy, and eye fatigue (dry eye syndrome). Qilu Pharmaceutical will continue to focus on unmet clinical medication needs, researching and producing high-quality domestically produced drugs that are accessible and affordable to the general public, continuously contributing to the growth and development of China's pharmaceutical industry.

Editor: Bai Ji

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