Understand the FDA cGMP 483 Analysis in One Article

2016-11-14

The FDA 483 report, also known as the on-site inspection report, is prepared by U.S. FDA inspectors following current U.S. laws and regulations after conducting an on-site inspection of a company. It summarizes any areas found to be non-compliant with cGMP requirements and is issued to the company. The company must immediately address and rectify all identified non-compliance issues and, within 15 working days of receiving the 483 report, submit a response to the relevant FDA division detailing the corrective actions taken for the non-compliant items. If the FDA determines that the company’s response is appropriate and meets the requirements of applicable laws and regulations, the company will avoid receiving an FDA warning letter. Each fiscal year, the FDA...

The CFDA is stepping up its game—after self-inspections, it will launch rigorous, no-holds-barred spot checks!

2016-11-14

The General Administration Office is publicly soliciting comments on the “Notice on Conducting Verification of Pharmaceutical Manufacturing Processes (Draft for Comments).” To further standardize the management of pharmaceutical manufacturing processes and ensure public drug safety, the State Administration for Market Regulation—Food and Drug Administration has drafted the “Notice on Conducting Verification of Pharmaceutical Manufacturing Processes (Draft for Comments)” and is now openly soliciting public input. Please submit any proposed revisions via email to the Drug and Cosmetic Registration Management Division of the State Administration for Market Regulation—Food and Drug Administration by September 10, 2016. Contact: Xue Yanjiu; Email: yhzcszhc@

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.

The U.S. to Release New Standards for Heparin Products; Pharmaceutical Companies Face Further Cost Pressures

2011-10-28

The U.S. will release new standards for heparin products.