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BAHEAL Pharmaceutical Passes FDA's cGMP Inspection with Zero Defects and Envisions Top Position in China's Generics Manufacturing

Published: 2017-03-20 16:23

BAHEAL Pharmaceutical Passes FDA's cGMP Inspection with Zero Defects and Envisions Top Position in China's Generics Manufacturing


BAHEAL Pharmaceutical Co. Ltd. has lately passed the on-site inspection of FDA's cGMP and PAI (Pre-approval Inspections) with zero defects. Thus it becomes one of the Chinese generics manufactures to enter the international market, which will help to elevate China's generics industry to the international level in the future.


The Opinions on Carrying Out Quality and Efficacy Conformity Evaluation of Generics publicized by the General Office of the State Council on March 5 this year marks the full swing of the evaluation of the generics on the Chinese market. A set of documents issued by the CFDA (China Food and Drug Administration) further promoted the efforts. These documents directly focus on the curative effect between Chinese generics and brand-name drugs. New drugs must contain originality, while generics must be identical to the brand-name drugs in terms of clinical efficacy. The unqualified generics shall not be authorized to enter the market. The evaluation will promote the restructuring in the domestic pharmaceutical industry, thus changing the fact that 80% of medical drugs sold in major hospitals are brand-name drugs. Consequently, the evaluation will improve the industry's competitiveness and phase out outdated production.


BAHEAL Pharmaceutical occupies a land area of 56,000 square meters. The production base is designed by the world-renowned pharmaceuticals designer NNE and is equipped with advanced preparation production facility, equipment and analyzing instrument. The company also has a team of preparation R&D, production and quality control which is characterized by its internationalization. The company takes technology innovation of preparations and compliance of cGMP as the core, featuring R&D of controlled-release solid preparations and drugs. Facing domestic and overseas markets, such as Europe and the U.S., the company is committed to being an international manufacturing platform of generics. At present, preparation products have been gradually developed and declared to the U.S. and Chinese market.


BAHEAL Pharmaceutical is targeting the R&D and production of high-end generics. In October 2016, the company passed FDA’s cGMP on-site inspection with zero defects, which has laid a solid foundation for the internationalization of preparations. In fact, passing the inspection with zero defects also means that BAHEAL Pharmaceutical can provide patients with medicines that are the same as brand-name drugs in terms of quality and curative effect, and have the ability of going into the international market. At the same time, it will accelerate the process of the products' coming into the market and enjoy preferential policies for those that have passed the evaluation.


BAHEAL Pharmaceutical not only pays attention to the construction of quality system by passing the cGMP inspection, but also focuses on technical innovation of preparations and talent introduction and cultivation, with the core competence featuring R&D and production of the controlled release technology.


Among chemical medicines, the controlled release preparation faces rather difficult technology with the most technical contents and high added values. Since the construction of the new plant, BAHEAL Pharmaceutical has obtained the facilities, equipment and technical capacities of producing release-controlled solid preparations, such as osmotic pumps, coated pellets, sustained release tablets and so on.


In the future, BAHEAL Pharmaceutical will make unremitting efforts to build an international manufacturing platform for generics. It will continue to develop high-end generics for therapeutic equivalents and provide quality medicines and preparations for China and the rest of the world.

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