The government of India has started conducting inspections at drug manufacturing units across the country to prevent the production of low-quality drugs and medicines in India. Typically, inspections are conducted by state authorities, while central agencies largely confine themselves to checking quality of final products put up on store shelves. However, in the last few […]
Alembic Pharmaceuticals Ltd said it received approval from the United States Food & Drug Administration for its abbreviated new drug application for Telmisartan and Amlodipine tablets for hypertension. The Telmisartan and Amlodipine Tablets are equivalent to the Twynsta tablets of Boehringer Ingelheim Pharmaceuticals, Inc. An Abbreviated New Drug Application (ANDA) is an application for a […]
Marksans Pharma Limited, an Indian pharmaceutical company, said it has received approval from the USFDA for the sale sale of its Loratadine Liquid Filled Capsules 10 mg in the US market. Loratadine is an antihistamine that reduces the effects of natural chemical histamine in the body and is used to treat sneezing, runny nose, watery […]
Dr. Reddy’s Laboratories Ltd said it launched Paricalcitol Injection, a therapeutic equivalent generic version of Zemplar injection in the United States market approved by the US Food & Drug Administration (USFDA). The Zemplar brand and generic had US sales of approximately $22.5 million for the most recent twelve months ending in July 2016 according to […]
Glenmark Pharmaceuticals, Inc., USA said it has entered into a strategic Development, License and Commercialization Agreement with Particle Sciences, Inc. to develop and market a generic version of Celgene’s Abraxane, used for cancer treatment. As per the terms of the agreement, Glenmark has obtained global exclusive marketing and distribution rights of the product upon commercialization. Particle […]
Pharma Major Lupin Limited (Lupin) announced that it received tentative approval from the United States Food and Drug Administration (FDA) for selling Silodosin capsules, a generic version of Allergan Sales’ Rapaflo capsules. Silodosin capsules are indicated for the treatment of the signs and symptoms of benign prostatic hyperplasia, or the enlargement of tissue due to […]
Pharma Major Lupin Limited announced that its US subsidiary, Gavis Pharmaceuticals LLC., received tentative approval for selling a generic version of Pfizer Inc.’s Zithromax oral suspension from the US FDA. Lupin had earlier received final approval for its Azithromycin Tablets and Azithromycin for Oral Suspension, filed from its Goa plant. Azithromycin per bottle are the […]
