Active Pharmaceutical Ingredient API News and Research

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FDA approves Mylan's ANDA for ER Tablets

Mylan today announced that its subsidiary Mylan Pharmaceuticals Inc. has received final approval from the U.S. Food and Drug Administration for its Abbreviated New Drug Application for Nisoldipine Extended-release Tablets, 8.5 mg, 17 mg, 25.5 mg and 34 mg.

29 Jan 2011

Watson predicts $4.2 billion in revenues from Global Generics and Global Brand businesses

During an investor meeting held today in New York, NY, Watson Pharmaceuticals, Inc. provided an update on its Global businesses, including a detailed overview of its commercial operations and pipeline developments within its Global Generics and Global Brands businesses, and an update of achievements within its Global Operations. In conjunction with the meeting, the Company provided its preliminary 2011 financial and long term growth forecasts.

21 Jan 2011

Selcia's radiochemistry facility granted GMP certificate

Selcia Limited, a leading independent provider of Carbon-14 (C-14) radiolabelling services, is pleased to announce that its radiochemistry facility has been granted a Good Manufacturing Practice (GMP) certificate for the preparationand C-14 labellingofActive Pharmaceutical Ingredients (APIs)for clinical trials following a successful inspection by the UK's Medicines and Healthcare products Regulatory Agency (MHRA).

7 Dec 2010

NIA awards Aphios Phase I Fast Track SBIR grant for development of novel AD nanodrug

Aphios® Corporation today announced that it was awarded Phase I of a Fast Track SBIR grant from the National Institute of Aging (NIA), National Institutes of Health (NIH) for Developing a Novel Alzheimer's Disease Nanodrug.

30 Nov 2010

Nuance releases PowerScribe 360 radiology reporting and communications platform

Nuance Communications, Inc. today announced PowerScribe 360, an advanced radiology reporting and communications platform that combines the best capabilities of PowerScribe and RadWhere into a unified solution. PowerScribe 360 was designed based on feedback and the extensive experience from Nuance's growing list of radiology customers, which today accounts for more than one third of all radiologists in the United States.

29 Nov 2010

SMI launches high-speed remote eye tracker

Just in time for the SfN Neuroscience 2010 Conference in San Diego, USA, SMI launches the RED500. The RED500 is the world's first high-performance and high-speed remote eye tracker, with 500Hz sampling rate, binocular tracking and a large tracking range.

16 Nov 2010

Cyplasin selects Aurobindo Pharma to supply API component for Ribavirin drug

Cyplasin Biomedical is a product-oriented, specialty pharmaceutical company focused on developing products for the multi-billion dollar hepatitis C virus (HCV) market. The Company is pleased to announce that it has selected Aurobindo Pharma located in Hyderabad , India to supply the active pharmaceutical ingredient (API) component for its Ribavirin drug product called C-Virin.

15 Nov 2010

Evotec revenues increase 33% to € 38.8 m during first nine months of 2010

Evotec AG today reported financial results and a corporate update for the first nine months of 2010.

11 Nov 2010

Fake antimalarial medications uncovered across Ghana

Substandard and counterfeit versions of thirteen key antimalarial medicines were uncovered in multiple locations across Ghana by the Medicines Quality Monitoring surveillance program. Set up by the Ghana Food and Drugs Board (FDB) in collaboration with the U.S. Pharmacopeial Convention (USP) and the U.S. Agency for International Development (USAID), the program samples antimalarials across the public and private sectors.

9 Nov 2010

Gentium third quarter total revenues increase to EUR 5.91 million

Gentium S.p.A. today reported financial results for the quarter ended September 30, 2010. The Company reports its financial condition and operating results using U.S. Generally Accepted Accounting Principles (GAAP). The Company's financial statements are prepared using the Euro as its functional currency.

8 Nov 2010

Cambrex acquires 51% equity stake in Zenara for $20M

Cambrex Corporation announced today that it acquired a 51% stake in Zenara Pharma, a Hyderabad, India based pharmaceutical company focused on the formulation of final dosage form products.

3 Nov 2010

Perrigo first quarter revenue increases 21% to record $641 million

Perrigo Company today announced results for its first quarter ended September 25, 2010.

2 Nov 2010

Teva third quarter net sales increase 20% to $4.3 billion

Teva Pharmaceutical Industries Ltd. today reported results for the quarter ended September 30, 2010.

2 Nov 2010

BioCryst 2010 third quarter revenue increases from $10.5 million to $12.0 million

BioCryst Pharmaceuticals, Inc. announced financial results for the third quarter and nine months ended September 30, 2010.

28 Oct 2010

B. Braun initiates voluntary recall of heparin injection products

B. Braun Medical Inc. was recently notified by its supplier, Scientific Protein Laboratories LLC (SPL), of a nationwide recall of a lot of Heparin Sodium USP Active Pharmaceutical Ingredient (API) sold to B. Braun because additional testing of retained crude heparin samples used by SPL to manufacture this single API lot indicated a trace amount of oversulfated chondroitin sulfate (OSCS) contaminant.

From B. Braun Melsungen AG 28 Oct 2010

Francisco Partners to invest in Quantros

Quantros, Inc., a leading provider of healthcare software and services for data management, decision support analytics, and clinical business intelligence, today announced that Francisco Partners, one of the world's largest technology-focused private equity firms, has agreed to make a significant capital investment in the company.

26 Oct 2010

ATMI and Austar open new Chinese manufacturing facility

ATMI, Inc. today announced that it has further extended its global biopharma manufacturing footprint with the opening of a new Chinese manufacturing facility as part of a joint venture with Austar, a Hong Kong-based comprehensive service provider to the China pharmaceutical industry.

25 Oct 2010

Particle Sciences enters licensing, technology agreement with Solubest

Particle Sciences Inc. (PSI), a leading pharmaceutical CRO and SoluBest have entered into a licensing and technology development agreement. Under the agreement, Particle Sciences will be the exclusive contract research provider in the U.S. for SoluBest's Solumer technology.

20 Oct 2010

API Healthcare signs contract with healthcare clients

API Healthcare, the leading healthcare-focused workforce management technology provider, today announced it has recently signed contracts with more than 30 healthcare clients seeking to improve efficiencies, reduce costs and improve patient outcomes with their end-to-end human capital optimization solutions.

14 Oct 2010

FDA warns of harmful stimulant in Slimming Beauty capsules

The U.S. Food and Drug Administration today advised consumers who have Slimming Beauty Bitter Orange Slimming Capsules not to use the product. FDA warns that Slimming Beauty Bitter Orange Slimming Capsules contain the active pharmaceutical ingredient sibutramine, a prescription-only drug which is a stimulant. Sibutramine is not listed on the product label and could harm consumers, especially those with cardiovascular conditions.

11 Oct 2010