Active Pharmaceutical Ingredient API News and Research

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Positron submits Drug Master File with FDA for production of API grade Sr-82

Positron Corporation, a leading molecular imaging healthcare company, is pleased to announce the submission of a Drug Master File (DMF), with the Federal Drug Administration (FDA), for the production of Active Pharmaceutical Ingredient (API) grade strontium-82, through its wholly owned subsidiary Manhattan Isotope Technology, LLC.

23 Aug 2012

Wockhardt receives final FDA approval for Felodipine ANDA to treat hypertension

Pharmaceutical and biotechnology major Wockhardt has received final approval from the United States Food & Drug Administration (US FDA) for marketing extended-release tablets containing 2.5mg, 5mg and 10mg Felodipine, which are used in treating hypertension.

22 Aug 2012

Meritage commences OBS Phase 2 clinical trial for eosinophilic esophagitis

Meritage Pharma, Inc. announced that it has initiated a Phase 2 clinical trial to evaluate oral budesonide suspension (OBS) for the treatment of adolescents and young adults with eosinophilic esophagitis (EoE), an allergic inflammatory condition of the esophagus. EoE is a chronic disease characterized by symptoms related to esophageal dysfunction and eosinophil-predominant inflammation.

13 Aug 2012

Mylan launches 18 antiretroviral products in India to treat HIV/AIDS

Mylan Inc., one of the world's leading generic and specialty pharmaceutical companies, today announced that its subsidiary, Mylan Pharmaceuticals Private Limited, has commenced commercial operations in India, starting with the launch of a comprehensive portfolio of 18 antiretroviral (ARV) products for the treatment of HIV/AIDS.

6 Aug 2012

New platform for detecting substandard and counterfeit medicines using microfluidics

A new platform for detecting substandard and counterfeit medicines using microfluidics has been recognized with a grant from Saving Lives at Birth's "Grand Challenge through Development." Dubbed PharmaCheck, the technology is a portable, field-based tool for assessing the quality of medicines in developing countries with increased accuracy, sensitivity and reliability.

27 Jul 2012

ScinoPharm to offer commercial manufacturing of topiramate API for VIVUS' Qsymia

ScinoPharm announced today that its Tainan, Taiwan Facility will provide commercial manufacturing of topiramate active pharmaceutical ingredient ("API") for VIVUS' Qsymia, a new drug for the treatment of obesity approved by the United States Food and Drug Administration on July 17, 2012.

19 Jul 2012

HIV and AIDS treatment: An interview with Charles Flexner, MD

The best estimates at the moment reckon that there are about 25 million people infected with HIV. Most of those are in resource-limited settings, including sub-Saharan Africa, South East Asia and India.

11 Jul 2012

Simple new procedure can remove impurities from pharmaceuticals

Scientists are reporting development of a simple new procedure for removing almost 98 percent of an important impurity that can contaminate prescription drugs and potentially increase the risk for adverse health effects in patients.

21 Jun 2012

FDA completes review of compounded hydroxyprogesterone caproate products and APIs

FDA (or the Agency) approved Makena (hydroxyprogesterone caproate) in February 2011 for the reduction of the risk of certain preterm births in women who have had at least one prior preterm birth. Beginning many years before Makena was approved, a version of the active ingredient of Makena has been available to patients whose physicians requested the drug from a pharmacist who compounded the drug.

18 Jun 2012

FDA approves RBI’s AppliGel-G for human testing

Royer Biomedical, Inc. (RBI) received FDA approval to proceed with Human Testing of AppliGel-G (Gentamicin) in management of Diabetic Foot Ulcers.

1 Jun 2012

Partnership between Molecular Profiles and GEA Process Engineering to demonstrate benefits of new technology

Molecular Profiles, a leading specialist contract research and manufacturing organisation, announces that it has entered into a strategic collaboration with GEA Process Engineering - the company behind the world-recognized GEA Niro spray drying technology.

29 May 2012

Teva first quarter net revenues increase 25% to $5.1 billion

Teva Pharmaceutical Industries Ltd. today reported results for the quarter ended March 31, 2012.

9 May 2012

MDGHA, CHAI and Mylan partner to fight childhood deaths caused by diarrhea

Mylan Laboratories Limited, the Indian subsidiary of Mylan Inc., today announced that it has entered into a partnership with the United Nation's Millennium Development Goals Health Alliance (MDGHA) and the Clinton Health Access Initiative (CHAI) to fight childhood deaths caused by diarrhea.

30 Apr 2012

Codexis receives FDA approval for sitagliptin manufacturing process

Codexis, Inc., a developer of industrial enzymes to enable the cost advantaged production of biofuels, bio-based chemicals, and pharmaceutical intermediates, today announced that the FDA has approved a new process co-developed by Codexis for the manufacture of sitagliptin, the active pharmaceutical ingredient in Merck's Januvia.

25 Apr 2012

Mylan receives FDA approval for generic Seroquel ANDA

Mylan Inc. today announced that its subsidiary Mylan Pharmaceuticals Inc. has received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Quetiapine Fumarate Tablets, 25 mg.

29 Mar 2012

eLink introduces Risk Services Connector application

Cloud solutions company eLink Business Innovations, Inc., today announced a new personnel management application that integrates with LexisNexis background check services to help simplify new employee screening.

27 Mar 2012

Endo acquires oxymorphone hydrochloride patent from Johnson Matthey

Endo announced today that it has acquired U.S. patent 7,851,482 B2 for oxymorphone hydrochloride, the key API in all formulations of OPANA, from Johnson Matthey plc.

23 Mar 2012

AB SCIEX introduces new triple quadrupole mass spectrometry instrumentation system

AB SCIEX, a global leader in life science analytical technologies, today announced the introduction of the AB SCIEX 4500 series, which is next-generation, mass spectrometry instrumentation that sets a new benchmark for routine quantitation and screening.

12 Mar 2012

Aptuit sells Clinical Trials Supply business to Catalent Pharma Solutions

Aptuit announces the completion of the sale of the Clinical Trials Supply business to Catalent Pharma Solutions on February 17, 2012. Timothy C. Tyson, Chairman and CEO of Aptuit, LLC stated that Aptuit will continue to deliver scientific and service excellence to provide integrated capabilities for the early to mid phase drug development markets.

18 Feb 2012