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Beilu Pharma's Dyclonine Hydrochloride Chemical Active Pharmaceutical Ingredient (API) Approved by NMPA

2026/05/14


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Recently, Beilu Pharma received the "Notification of Approval for Marketing Application of Chemical API" for Dyclonine Hydrochloride approved and issued by the National Medical Products Administration (NMPA).


Dyclonine Hydrochloride possesses local anesthetic, analgesic, antipruritic, and bacteriostatic effects. Its mechanism of action involves blocking the conduction of nerve impulses, inhibiting nerve ending receptors, and reducing the sensitivity of peripheral nerve endings, thereby exerting surface anesthetic, analgesic, and antipruritic effects. Clinical applications include local anesthesia for endoscopic examination, relief of pain and itching on skin and mucous membranes, and reduction of skin sensitivity. The API can be used in topical preparations such as Dyclonine Hydrochloride solutions, cream, gels, and mucilage products.


The acquisition of the "Notification of Approval for Marketing Application of Chemical API" for Dyclonine Hydrochloride indicates that this API has met the relevant national technical standards for API evaluation. After complying with the Good Manufacturing Practice (GMP) requirements, it can be manufactured and sold in the domestic market, further enriching Beilu Pharma's product line and enhancing the market competitiveness of its products. Beilu Pharma will actively prepare for the launch of the new product and push it to the market as soon as possible.


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