Delivers up-to-date industry news on topics like drug approvals, product recalls, company expansions and acquisitions, market trends for all OSD forms, as well as excipients, packaging and supply chain issues. Monitors market trends in specific drug categories as well as in supplements/nutraceuticals. Provides updates on clinical trials. Includes alerts about new or upcoming regulatory issues.
Extractable and leachable (E&L) testing determines whether unwanted and potentially harmful compounds are pulled out of a product’s packaging, delivery system, or manufacturing surface under certain conditions (extractables) or passively migrate into a product over time (leachables). As part of the US FDA guidelines, all drug products in ...
read more
Daily intake of several minerals, including calcium, iron, copper, magnesium, manganese, and zinc as well as several other trace minerals, is necessary for the proper function, growth, and overall health of the human body. Increasing consumer interest and a willingness to spend more on mineral supplement products are expected to contribute to a ...
read more
Pfizer is recalling an additional four lots of Chantix 0.5mg/1 mg due to the presence of a nitrosamine, N-nitroso-varenicline, above the Pfizer established Acceptable Daily Intake (ADI) level.
read more
Lupin Pharmaceuticals Inc. is voluntarily recalling the below-mentioned batches of Irbesartan Tablets and Irbesartan and Hydrochlorothiazide Tablets to the consumer level. As part of Lupin’s ongoing assessment, analysis revealed that certain tested API batches (but not finished product batches) were above the specification limit for the impurity, N...
read more
USAntibiotics, the sole-licensed American maker of penicillin-based Amoxil® (amoxicillin) and Augmentin® (amoxicillin clavulanate), announced that it has relaunched production of the nation's only Amoxicillin manufacturing facility. When it reaches full production capacity in 2022, it will be able to produce enough Amoxicillin products to meet 100 ...
read more
Roquette, a provider of plant-based ingredients and naturally-derived pharmaceutical excipients, announced its plans to open a new Innovation Center in the US to further the advancement of prescription drugs – and beyond. Located in Pennsylvania, the new state-of-the-art facility aims to better serve Roquette’s global customer base by working ...
read more
Dr. Reddy’s Laboratories Ltd. announced the launch of Valsartan Tablets, USP, a therapeutic equivalent generic version of Diovan® (valsartan) Tablets approved by the U.S. Food and Drug Administration (USFDA).
read more
Dr. Reddy’s Laboratories Ltd. announced the launch of Venlafaxine ER Tablets which is therapeutically equivalent to Venlafaxine Extended-Release Tablets, 150 mg and 225 mg, of Osmotica Pharmaceutical US LLC approved by the U.S. Food and Drug Administration (USFDA).
read more
ANI Pharmaceuticals, Inc. announced that the Company received FDA approval for the Abbreviated New Drug Application for Rifabutin Capsules USP, 150 mg.
read more
Piramal Enterprises Limited's Pharma Solutions business, a Contract Development and Manufacturing Organization (CDMO), announced that the company has added development/commercial scale roller compaction technology to its Sellersville, Pennsylvania drug product facility.
read more
Virtual Pharma Expo, a digital event series for pharmaceutical equipment manufacturers looking to learn about the latest equipment technology, announced three events for 2022.
read more
Recro Pharma, Inc. announced the appointment of Eduardo Uribe as the company’s head of quality for Recro San Diego.
read more
Catalent, the global leader in enabling biopharma, cell, gene, and consumer health partners to optimize development, launch, and supply of better patient treatments across multiple modalities, today announced the launch of its new Xpress Pharmaceutics™ service, designed to accelerate the development of oral drugs through Phase 1 clinical studies. ...
read more
Ascletis Pharma Inc. ("Ascletis") (HKEX: 1672) today announces signing of the ritonavir tablet purchase agreement between Phokam Pharmaceutical Import-Export Co., Ltd (as buyer) of Laos and Ascletis Pharmaceuticals Co., Ltd. (as seller), a wholly-owned subsidiary of Ascletis Pharma Inc.
read more
Catalent announced that it has completed a $10 million expansion in state-of-the-art large-scale isolator units at its Malvern, Pennsylvania, and Dartford, U.K., facilities, to provide advanced containment capabilities for the micronization of highly potent drug compounds.
read more