Low-molecular-weight heparin products are being upgraded, and we’ll closely watch as the market landscape evolves.

2016-11-14

To date, cardiovascular and cerebrovascular diseases remain the leading cause of death worldwide. Currently, therapeutic drugs for heart and brain strokes primarily fall into three major categories: antithrombotic, anticoagulant, and antiplatelet agents. The 2009 edition of the National Medical Insurance Catalog lists 19 chemical entities in these three categories—among them, heparin, low-molecular-weight heparin, rivaroxaban, warfarin, and kinase-based drugs are the main ones used in clinical practice and play an irreplaceable and critical role. According to comprehensive data from the China Pharmaceutical Industry Information Center’s PDB database, the global pharmaceutical market for antithrombotic, anticoagulant, and antiplatelet agents remained stable in 2015, with demand driven by rigid market needs.

Who dominates the domestic 8-billion-Heparin market?

2016-09-29

The global economic outlook for 2016 is not optimistic. The weak external demand and the broader economic downturn have a significant impact on exports of sodium heparin APIs, an impact that cannot be underestimated. According to experts from Shanghai Shiyi Technology in the heparin field, in 2016, exports of low-molecular-weight heparin generally remained stable and showed a positive trend. Driven by robust demand for high-end products, the domestic market for heparin-based formulations continues to exhibit a sustained growth trajectory. With the introduction of national policies, it has become an inevitable trend to set high standards and stringent requirements for product quality. Following the implementation of the 2015 edition of the Chinese Pharmacopoeia, the assay methods for heparin potency have been comprehensively standardized.

A reporter from the U.S. magazine C&EN Chemical Engineering & News conducted an exclusive interview with Hubei Yinuorui Company.

2016-09-18

Recently, Hubei Enoray Biopharmaceutical Co., Ltd. was interviewed by Jean-François Tremblay, a Hong Kong-based Asia-Pacific correspondent for Chemical & Engineering News (C&EN), a publication in the U.S. pharmaceutical and chemical industry. This magazine is a weekly publication issued by the American Chemical Society. It focuses on the latest developments in the world of chemistry and reports on trends in research, industry, education, and other fields related to chemistry. The magazine is distributed to all members of the American Chemical Society as a...

Our company has successfully passed the on-site GMP certification inspection for the raw material of low-molecular-weight heparin calcium.

2016-09-12

From September 9 to September 11, 2016, the Technical Review and Inspection Center of the Hubei Provincial Administration for Food and Drug Supervision organized experts to conduct an on-site inspection of our company for the GMP certification of low-molecular-weight heparin calcium raw material drug. During the on-site inspection, the experts conducted a rigorous and meticulous review of every aspect of our company’s production and quality management processes for the low-molecular-weight heparin calcium raw material drug. They gave a positive evaluation of our company’s GMP management practices and put forward specific requirements for rectifying any identified deficiencies. Thanks to more than six months of diligent preparation and continuous improvement by all members of YinoRui’s production and quality management teams, this...

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.