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Baheal Pharma's New High-end Generic Drug Duloxetine Capsules Approved for Marketing


Qingdao Baheal Pharmaceutical Co. Ltd. (hereinafter referred to as "Baheal Pharma") announced that its Duloxetine Hydrochloride Enteric Capsules have been approved by the National Medical Products Administration (NMPA) with the approval numbers H20203674, H20203675 and H20203676. Duloxetine was granted marketing authorization by the FDA in April 2019, and this time it has received the drug approval certificate in China, which means that the product has passed the consistency evaluation - the quality, efficacy and safety of the high-quality domestic drug will be consistent with the imported drug, and it also marks that the "Baheal-made Duloxetine" can be reported and sold in the same way in China and the United States, bringing a new choice of medication for patients with depression and anxiety.


According to the NMPA official website, among the 60 drug approvals released, Baheal Pharma's Duloxetine capsules are deemed to have passed the consistency evaluation with the new registration classification. Duloxetine is mainly used for the treatment of depression and generalized anxiety disorder, especially for depressed patients with pain and other physical symptoms. Baheal Pharma is mainly engaged in the research, development, production and sales of slow and controlled release solid dosage form products, and has passed the US FDA approval with zero defects, laying a solid foundation for the internationalization of the formulation.


Duloxetine has been widely accepted by the clinical community because of its good tolerability, significant efficacy and fast onset of action, as well as its simple dosing regimen and low side effects. The Duloxetine hydrochloride enteric coated capsule approved by Baheal Pharma belongs to the enteric micro-pill coating process (including drug layer, barrier layer and enteric layer), which is a complex production process and poses a great challenge to the drug formulation technology.


At present, metformin hydrochloride extended-release tablets (III) Nida, duloxetine hydrochloride enteric capsules and celecoxib capsules under Baheal Pharma have been approved for marketing by FDA and NMPA. The company has so far established 13 high-end generic drugs, and will continue to develop and market high-end generic drugs that meet the therapeutic equivalence in the future to provide excellent quality pharmaceutical preparations for China and other countries in the world.