The registration documents for heparin sodium active pharmaceutical ingredient have been successfully submitted and accepted domestically.

2016-07-18

After more than six months of joint efforts by the Pharmaceutical Administration Department and all members of the Production Quality System, the company has completed all preparatory work for the initial preparation of the domestic registration documents for its sodium heparin active pharmaceutical ingredient. Recently, these documents were formally submitted to the Hubei Provincial Administration for Market Regulation of Food and Drugs, and the company has received a notice of acceptance.

U.S. FDA prosecutors conducted an unannounced inspection of our company.

2015-01-12

On January 12, 2015, without prior notice, Ms. Susan and one other FDA inspector from the U.S. Food and Drug Administration conducted a two-day unannounced, walk-in inspection of our company’s crude heparin sodium production facility. Thanks to our company’s consistently robust quality control measures and the enthusiastic, confident attitude of our management team during the inspection, the inspectors were deeply impressed by our company’s well-established crude heparin quality system and advanced hardware facilities, and they delivered a highly positive and favorable assessment. At the conclusion of the inspection, Ms. Susan warmly invited our management team to take a commemorative group photo together.

Governor Wang Guosheng visited our company for research and inspection.

2013-04-01

On April 1, Governor Wang Guosheng visited Xiaochi in Huangmei to accelerate the advancement of county-level economic and social development. He made a special trip to our company to inspect and provide guidance on our work.

Secretary Li Hongzhong, Secretary of the Provincial Party Committee, visited our company to inspect and provide guidance.

2012-12-27

On December 27, Li Hongzhong, Secretary of the Provincial Party Committee, and Wang Xiaodong, a member of the Standing Committee of the Provincial Party Committee and Executive Vice Governor, conducted a special research visit to accelerate the opening-up and development of Xiaochi in Huangmei. They made a special trip to our company to inspect and provide guidance. Secretary Li Hongzhong visited the company’s exhibition hall, quality inspection center, and API raw material pharmaceutical workshop one after another. Upon learning about our company’s goal of “building the largest heparin-based biochemical drug base in China and creating a 10-billion-yuan industrial park,” he encouraged our company to seize the opportunities presented by Xiaochi’s opening-up and development, strengthen scientific and technological R&D, attract top talent, and become a flagship enterprise within the park.

Our company has been approved to obtain a drug production license issued by the Hubei Provincial Administration for Market Regulation of Food and Drugs.

2011-06-08

Today, our company officially obtained the Drug Production License issued by the Hubei Provincial Administration for Market Regulation of Food and Drugs. The scope of permitted production includes: active pharmaceutical ingredients (sodium heparin, calcium heparin, enoxaparin sodium, dalteparin, nadroparin calcium).

Hubei Enoray Biopharmaceutical Co., Ltd. has been officially established and registered with the industrial and commercial authorities.

2010-10-17

On October 17, 2010, Hubei Enoray Biopharmaceutical Co., Ltd. was officially established after being registered with the Huangmei County Administration for Industry and Commerce. A biopharmaceutical enterprise specializing in the heparin industry—focused on the R&D and production of heparin, graded low-molecular-weight heparin APIs, and novel antithrombotic drugs—was born in Xiaochi, Huangmei, Hubei. Today, starting from this very place and guided by a grand blueprint, it is destined to step out of China and reach the entire world!