Pharmaceutical Manufacturing News and Research

RSS

Seward highlights effectiveness of Stomacher technique and sponge swabs for hygiene monitoring

Seward Ltd., manufacturers of the world leading range of Stomacher paddle blenders and Stomacher® accessories used in sample preparation for microbiological analyses, have highlighted the highly effective use of its Stomacher technology in combination with sponge swabs for hygiene monitoring and biosecurity applications.

28 Jan 2014

New method allows for large-scale generation of human embryonic stem cells

A new method allows for large-scale generation of human embryonic stem cells of high clinical quality. It also allows for production of such cells without destroying any human embryos.

27 Jan 2014

NextSource BioTechnology announces product re-launch, market availability of Lomustine in U.S.

NextSource BioTechnology, LLC, (NSB), an emerging Specialty Pharmaceutical Manufacturing and Marketing Company focused on Consolidating, Re-Branding and Launching "Matured & Orphan Drugs," has announced its most recent product Lomustine (CCNU), formerly known as CeeNu® by Bristol-Myers Squibb (BMS), which has officially been removed from the U.S. Food & Drug Administration (FDA) Drug Shortage List.

27 Jan 2014

Cantrell Drug Company amends FDA registration to include 503B compounding outsourcing facility

Cantrell Drug Company today announced amendment of its U.S. Food and Drug Administration (FDA) registration to include the new 503B "compounding outsourcing facility" designation established under the recently passed Drug Quality and Security Act so that it can continue to serve patients nationwide with sterile medications that meet the most exacting quality standards.

25 Jan 2014

FDA completes inspection of LSNE's medical device manufacturing facility in Manchester

Lyophilization Services of New England, a New Hampshire based contract manufacturing organization is pleased to announce that the Food and Drug Administration recently completed an inspection of their Manchester manufacturing facility.

8 Jan 2014

ScinoPharm constructs Changshu plant in China

ScinoPharm today announced that the company has completed construction of its Changshu plant on a 16-acre (6.5-hectare) site.

12 Dec 2013

Rensselaer professors team up to develop innovative biomanufacturing technology

Two chemical engineering professors at Rensselaer Polytechnic Institute are contributing to a collaboration among academia, industry, and the federal government to develop a method for rapidly manufacturing biologic drugs.

4 Dec 2013

New diagnostic products from Avantor™ Performance Materials featured at MEDICA 2013

Avantor™ Performance Materials will display its capabilities as a trusted collaborator and provider of high-quality diagnostic solutions at MEDICA 2013, November 20-23 at the Dusseldorf Fairgrounds in Germany.

12 Nov 2013

FDA proposes rule to speed dissemination of new safety information about generic drugs

A proposed U.S. Food and Drug Administration rule would speed the dissemination of new safety information about generic drugs to health professionals and patients by allowing generic drug makers to use the same process as brand drug manufacturers to update safety information in the product labeling.

11 Nov 2013

First generic versions of Aciphex delayed-release tablets get FDA approval for GERD treatment

The U.S. Food and Drug Administration today approved the first generic versions of Aciphex (rabeprazole sodium) delayed-release tablets, used to treat gastroesophageal reflux disease in adults and adolescents (ages 12 and up).

10 Nov 2013

MIT investigators receive DARPA grant to develop new technologies for BioMOD program

Investigators from MIT's Biomanufacturing Research Program (BioMAN) have received a $10.4 million grant from the Defense Advanced Research Projects Agency (DARPA) to develop new technologies for DARPA's Biologically-derived Medicines On Demand (BioMOD) program.

5 Oct 2013

Metabolic enzymes in opium poppy are used to produce valuable painkilling drugs

University of Calgary scientists have discovered metabolic enzymes in the opium poppy that play "widespread roles" in enabling the plant to make painkilling morphine and codeine, and other important compounds.

5 Oct 2013

Federal judge passes consent order against Shamrock Medical for distributing mislabeled drugs

The U.S. Food and Drug Administration announced today that federal judge Algenon L. Marbley of the Southern District of Ohio has approved a consent decree of permanent injunction against Shamrock Medical Solutions Group, LLC, of Lewis Center, Ohio, and four of its corporate officers and employees for continued drug manufacturing and labeling violations that resulted in the distribution of mislabeled drugs.

19 Sep 2013

FDA issues import alert on drug products manufactured at Ranbaxy's facility in Mohali, India

The U.S. Food and Drug Administration today issued an import alert under which U.S. officials may detain at the U.S. border drug products manufactured at Ranbaxy Laboratories, Ltd.'s facility in Mohali, India.

17 Sep 2013

First generic version of Xeloda gets FDA approval for breast and colorectal cancers

The U.S. Food and Drug Administration today approved the first generic version of Xeloda (capecitabine), an oral chemotherapy pill used to treat cancer of the colon or rectum (colorectal cancer) that has spread to other parts of the body (metastatic), and metastatic breast cancer.

17 Sep 2013

Dakota Laboratories banned from manufacturing and distributing drugs

Dakota Laboratories LLC and its president, Charles L. Voellinger, Sr., are prohibited from manufacturing and distributing drugs until they correct their ongoing violations of the drug manufacturing laws.

4 Sep 2013

Arrays of nanoscale sensors detect flaws in drugs and help improve production

MIT chemical engineers have discovered that arrays of billions of nanoscale sensors have unique properties that could help pharmaceutical companies produce drugs - especially those based on antibodies - more safely and efficiently.

17 Aug 2013

Sugar offers noninvasive way to precisely image tumors through new imaging technology

A natural form of sugar could offer a new, noninvasive way to precisely image tumors and potentially see whether cancer medication is effective, by means of a new imaging technology developed at UC San Francisco in collaboration with GE Healthcare.

16 Aug 2013

AMRI receives a Form 483 from the FDA for Burlington pharmaceutical manufacturing facility

As previously disclosed, Albany Molecular Research, Inc. ("AMRI" or "the "Company") (NASDAQ: AMRI) received a warning letter, dated August 17, 2010, from the U.S. Food and Drug Administration (FDA) in connection with the FDA's inspection of the Company's pharmaceutical manufacturing facility located in Burlington, Massachusetts.

23 Jul 2013

Roche introduces new metabolite tests for cell fermentation analytics

Roche today announced the launch of new metabolite-testing reagent sets to determine the concentration of iron and phosphate, two parameters relevant for cell growth and productivity during fermentation processes.

4 Jul 2013