Tag: Generics

A generic drug is a pharmaceutical drug that is equivalent to a brand-name product in dosage, strength, route of administration, quality, performance, and intended use. The term may also refer to any drug marketed under its chemical name without advertising, or to the chemical makeup of a drug rather than the brand name under which the drug is sold.

EC and UK OECD Stressed Importance of Generics and Biosimilars for Healthcare Systems

A joint report has been issued by the European Commission (EC) and the UK Organisation for Economic Co-operation and Development (OECD) on healthcare in the EU, highlighting the importance of generics...

Hikma Submitted Response for Advair® to FDA

hikma
Hikma Pharmaceuticals PLC, the multinational pharmaceutical company, announces that it has submitted to the US Food and Drug Administration (FDA) its response to deficiencies in its abbreviate...

FDA Approved Glenmark Generic Version of Glumetza®

Glenmark Pharmaceuticals Inc., USA (Glenmark) has been granted final approval by the United States Food & Drug Administration (U.S. FDA) for Metformin Hydrochloride Extended-Release Tablets USP, 5...

Absorption Systems Got FDA Contract to Conduct Testing of Effects of Excipients on Oral Drug Absorpt...

generics
Absorption Systems has been awarded a 2-year contract for a total amount of approximately $300,000 by the U.S. Food and Drug Administration (FDA). The funding mechanism is a Broad Agency Announcement ...

Oakrum and SunGen Launch Generic Methylprednisolone

drugs quality control
Oakrum Pharma, LLC,  in collaboration with SunGen Pharma, LLC, announced the U.S. launch and commercial shipment of a generic version of Medrol® (Methylprednisolone) in 4 mg tablets. It is ...

FDA Approved Glenmark’s Abiraterone Acetate Tablets

Glenmark Pharmaceuticals Inc., USA (Glenmark) has been granted final approval by the United States Food & Drug Administration (U.S. FDA) for Abiraterone Acetate Tablets USP, 250 mg, a generic vers...

FDA Update on Patient Access to High-Quality, Low-Cost Generics Enhancement

fda
Affordable access to medicines is a public health concern and more generic drug competition can help reduce prices, improve access and benefit the public health. Safe, effective and high-quality gener...

Sun Pharma Launched Drizalma Sprinkle™ in the U.S.

Sun Pharmaceutical Industries Ltd. announced that one of its wholly owned subsidiaries has launched Drizalma Sprinkle™ (duloxetine delayed-release capsules) in the U.S. for oral use. Drizalma Sprin...

FDA Approved Dimethyl Fumarate Delayed-Release Capsules

glenmark
Glenmark Pharmaceuticals Inc., USA (Glenmark) has been granted tentative approval by the United States Food & Drug Administration (U.S. FDA) for Dimethyl Fumarate Delayed-Release Capsules, 120 mg ...

MedicaSafe Announced Partnership with Amneal Pharmaceuticals

partnership
MedicaSafe, Inc. announced a partnership with Amneal Pharmaceuticals, Inc.to provide Amneal’s generic version of Suboxone® (buprenorphine and naloxone) as part of MedicaSafe’s data-generating medicati...

Eisai and Nichi-Iko Entered Collaboration Agreement for Generics in China

generic
Eisai Co., Ltd. and Nichi-Iko Pharmaceutical announced that they have entered into a comprehensive collaboration agreement for the generic pharmaceutical business in China. The Chinese pharmaceutic...

Astellas and FibroGen’s Evrenzo® Approved in Japan

astellas
Astellas Pharma Inc. and FibroGen, Inc. announced that Japan’s Ministry of Health, Labour and Welfare (MHLW) approved Evrenzo® (generic name: roxadustat) for the treatment of anemia associated with ch...

Mylan Announced U.S. Launch of Generic Fulvestrant Injection

mylan
Mylan N.V. announced the U.S. launch of Fulvestrant Injection, 250 mg/5 mL (50 mg/mL) per single-dose prefilled syringe, a generic version of AstraZeneca's Faslodex® Injection. Mylan received final...

Daiichi Sankyo Launched Oxycodone Extended Release Tablets NX “Daiichi Sankyo” in Japan

Daiichi Sankyo Company Limited announced it has launched a new generic formulation of oxycodone hydrochloride hydrate extended release tablets for sustained cancer pain treatment in Japan: Oxycodone E...

Biocon Signed Agreement with Subsidiary of CMS for Three Generic Formulation Products

biocon
Biocon Ltd, Asia’s premier biopharmaceuticals company, announced that it has signed a License and Supply Agreement with a subsidiary of China Medical System Holdings Ltd. (CMS) for three Generic Formu...

Strides to Acquire Majority Stake in Fairmed

Strides Pharma Science Limited has announced its acquisition of majority stake in Fairmed Healthcare AG. Strides Pharma Global Pvt Ltd (SPG) is a step down subsidiary of Strides Pharma Science Limi...