Active Pharmaceutical Ingredient API News and Research

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Elsevier launches new version of BrainNavigator online research tool

Elsevier, the leading publisher of scientific, technical and medical information products and services, today announced a new version of its online research tool BrainNavigator.

6 Oct 2010

SAFC expands fermentation capabilities in Israel facility

SAFC, a member of the Sigma-Aldrich® Group (Nasdaq: SIAL), today announced the completion of its state-of-the-art expansion of its Jerusalem, Israel facility. The additional capacity expands SAFC's contract manufacturing capabilities in large molecule recombinant proteins and small molecule Active Pharmaceutical Ingredients (APIs) through fermentation, including High Potent APIs (HPAPIs) and secondary metabolites.

6 Oct 2010

FDA grants Matrix tentative approval under PEPFAR for Atazanavir Sulfate Capsules ANDA

Mylan Inc. today announced that its subsidiary Matrix Laboratories Limited has received tentative approval from the U.S. Food and Drug Administration (FDA) under the President's Emergency Plan for AIDS Relief (PEPFAR) for its Abbreviated New Drug Application (ANDA) for Atazanavir Sulfate Capsules, 150 mg and 300 mg. This product will be eligible for purchase outside the U.S. in certain developing countries.

5 Oct 2010

Covance, sanofi-aventis enter definitive agreement for R&D partnership

Covance Inc. today announced the signing of definitive agreements with sanofi-aventis for Covance to become sanofi-aventis' R&D partner. Over the next ten years, Covance expects to provide drug development services to sanofi-aventis, with estimated payments ranging from approximately $1.2 billion to $2.2 billion.

30 Sep 2010

Santarus, Cosmo announce positive results from budesonide MMX Phase III study in ulcerative colitis

Santarus, Inc. and Cosmo Pharmaceuticals S.p.A. today announced positive top-line results from the Phase III clinical study conducted in the U.S. and India to evaluate the safety and efficacy of budesonide MMX® for the induction of remission of mild or moderate active ulcerative colitis. The study results show that budesonide MMX 9 mg taken once daily met the primary endpoint of superiority to placebo.

30 Sep 2010

Perrigo receives FDA approval to manufacture, market Imiquimod Cream, 5%

Perrigo Company announced it received FDA approval from the U.S. Food and Drug Administration to manufacture and market Imiquimod Cream, 5%. Perrigo will vertically integrate this product with their own API.

8 Sep 2010

DSM Pharma launches InnoSyn route scouting services for pharmaceutical customers

DSM Pharma Chemicals, a business unit of DSM Pharmaceutical Products, today announced the launch of InnoSyn™ route scouting services. In response to the increasing interest of pharmaceutical customers to outsource the development of robust low-cost manufacturing routes, DSM is offering focused and flexible stand alone route scouting services.

7 Sep 2010

RIFM publishes special issue on safety assessment of unsaturated alcohols

The Research Institute for Fragrance Materials, Inc. (RIFM) has now published on the RIFM web site, in the Publications section, a special issue of Food and Chemical Toxicology, Volume 48, Supplement 3, on the RIFM Human Health Group Summary, A Safety Assessment of Non-cyclic Alcohols with Unsaturated Branched Chain when used as Fragrance Ingredients.

4 Sep 2010

ScinoPharm announces investment with Tanvex Biologics

ScinoPharm, a leading active pharmaceutical ingredient (API) developer and manufacturer headquartered in Taiwan, today announced an investment into Tanvex Biologics, Inc., a United States company registered in the State of Delaware. ScinoPharm's investment was in the form of tangible assets, intellectual properties, as well as cash.

2 Sep 2010

IriSys signs business alliance agreement with Xcelience

IriSys and Xcelience have entered into a business alliance agreement to advance the ability to streamline access to CMC and regulatory expertise for North American pharmaceutical and biotechnology companies.

30 Aug 2010

Ricerca Biosciences completes purification of an API under cGMP controls

Ricerca Biosciences, a uniquely integrated preclinical contract research organization (CRO) providing services to the biopharmaceutical industry, is pleased to announce the successful completion of the purification of an active pharmaceutical ingredient (API) under current good manufacturing practices (cGMP) controls.

27 Aug 2010

Lotus Pharmaceuticals second-quarter net income increases 32% to $6.3 million

Lotus Pharmaceuticals, Inc., a growing developer, manufacturer and seller of medicine and drugs in the People's Republic of China, reported today its financial results for the quarter and six months ended June 30, 2010.

16 Aug 2010

NeoStem second-quarter revenues increase 26% to $19.4 million

NeoStem, Inc. an international biopharmaceutical company with product and service revenues, global research and development capabilities and operations in three distinct business units, U.S. adult stem cells, China adult stem cells, and China pharmaceuticals is today providing results of its second quarter 2010.

16 Aug 2010

AMRI selected as inaugural winner of Pfizer Route Design Innovation Award

AMRI announced today that it has been selected as the inaugural winner of the Pfizer Route Design Innovation Award, beating out 40 companies who were invited to share innovative ideas for process chemistry and large scale Active Pharmaceutical Ingredient production. Pfizer will present the company with the award at the AMRI 2010 Integrated Drug Discovery Symposium to be held in Albany NY, October 13-14. AMRI will also receive an honorarium for its win.

16 Aug 2010

Gentium second-quarter total revenues increase to EUR 7.55 million

Gentium S.p.A. today reported financial results for the first half of 2010 and for the quarter ended June 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.

12 Aug 2010

Perrigo fourth-quarter fiscal 2010 net sales up 22%

Perrigo Company today announced results for its fourth quarter and full year ended June 26, 2010.

12 Aug 2010

Evotec revenues for first-half of 2010 increase 33% to € 25.0 m

Evotec AG today reported financial results and corporate updates for the first half of 2010.

12 Aug 2010

Synthetech first-quarter fiscal 2011 revenue decreases 56% to $2.0 million

Synthetech, Inc. today announced financial results for the first quarter of fiscal 2011, which ended June 30, 2010. Revenue for the quarter was $2.0 million, a 56% decrease compared to revenue of $4.7 million in the first quarter of fiscal 2010. The operating loss for the current quarter was $727,000, compared to operating income of $1.0 million for the same period last year. The net loss for the current quarter was $763,000, or $0.05 per basic share, compared to last year's first quarter net income of $969,000, or $0.07 per basic share.

7 Aug 2010

BioCryst second-quarter total revenues increase to $7.6 million

BioCryst Pharmaceuticals, Inc. announced financial results for the second quarter and six months ended June 30, 2010.

5 Aug 2010

Optimer second-quarter net loss decreases to $10.4 million

Optimer Pharmaceuticals, Inc. today reported financial results for the second quarter ended June 30, 2010. Optimer reported a net loss for the second quarter of 2010 of $10.4 million, or $0.27 per share, which was in line with the Company's expectations. This compares to a net loss for the second quarter of 2009 of $12.4 million, or $0.37 per share. The decrease in net loss was primarily due to lower research and development expenses offset by an increase in general and administrative expenses.

5 Aug 2010