August 8th 2024
Biopharmaceutical production faces the challenge of ensuring the quality of raw materials due to a lack of specific guidelines. By implementing effective risk assessment strategies and working with reliable, selected solution providers, biopharmaceutical manufacturers can minimize these challenges and improve product quality.
Merck Forms Joint Venture with Sun Pharmaceutical
April 14th 2011Merck & Co. has formed a joint venture with the Mumbai-based specialty pharmaceutical company Sun Pharmaceutical Industries to develop, manufacture, and commercialize new combinations and formulations of branded generic drugs in emerging markets.
SOCMA and EFCG Urge for Reform in FDA Inspections of Foreign Drug-Manufacturing Facilities
March 17th 2011The Bulk Pharmaceutical Task Force (BPTF) of the Society for Chemical Manufacturers and Affiliates (SOCMA) and the European Fine Chemicals Group (EFCG) of the European Chemical Industry Council (CEFIC) are calling on FDA to mandate inspections of foreign active pharmaceutical ingredient (API) manufacturing sites with the cost borne by those sites being inspected. Both organizations have indicated a willingness to pay fees for these inspections when performed on their member-owned facilities that are located outside the United States.
Drug Development for Government, Nonprofit, and Developing-World Markets
March 2nd 2011This article is Part I of a three-part series on biopharmaceutical issues in public health, government, and developing-world markets. Part 1 focuses on drug-development. Part II, which examines manufacturing, appeared in the April 2011 of Sourcing and Management. Part III, which analyzes distribution and administration,appeared in the May 2011 issue.
SOCMA Urges Congressional Action on Chemical-Site Security Standards
February 24th 2011The Society of Chemical Manufacturers and Affiliates (SOCMA), in a statement submitted to the US House Subcommittee on Cybersecurity, Infrastructure Protection and Security Technologies, called for Congressional action to pass a three-to-five year authorization of current Chemical Facility Anti-Terrorism Standards (CFATS), which are scheduled to expire Mar. 4, 2011.
SOCMA Issues Statement to US Senate Subcommittee on TSCA Reform
February 10th 2011The Society of Chemical Manufacturers and Affiliates (SOCMA), in a statement submitted to the US Senate Subcommittee on Superfund, Toxic and Environmental Health, provided support for a bipartisan review of the Toxic Substances Control Act (TSCA) as that subcommittee considers reforming the chemical control law.