Sun's generic of Takeda ulcer drug gets FDA nod

Generics |  Regulatory | By BioSpectrum Bureau  | 0 Comment | 16 Sep, 2013

Singapore: Indian pharmaceutical major, Sun Pharmaceutical Industries announced that the generic version of Prevacid by the company has received that final approval from the US FDA. The Am...Read more

Teva to pay $718 mn to apex tax body in Israel

Generics |  News | By BioSpectrum Bureau  | 0 Comment | 13 Nov, 2013

Singapore: Israel-based Teva Pharmaceutical is going to pay $718 million to Israel Tax Authority to pay for the release of trapped profits, settling tax assessments for the years 2005-07 an...Read more

Sandoz gets FDA nod for MS generic drug

Generics |  News | By BioSpectrum Bureau  | 0 Comment | 17 Apr, 2015

Singapore: Sandoz, a Novartis company, has recieved USFDA approval of Glatopa, a first generic version of Teva's Copaxone (glatiramer acetate injection) for multiple sclerosis therapy. "Sa...Read more

Drug shortage forces FDA to approve cancer generic

Generics |  News | By BioSpectrum Bureau  | 0 Comment | 06 Nov, 2013

Singapore: The US FDA has provided its approval for a generic version of cancer drug Doxil that has been facing shortage due to manufacturing deficiencies. This generic version of the drug...Read more

Hong Kong to host international TCM exhibition, conference

Generics |  News | By BioSpectrum Bureau  | 0 Comment | 12 Aug, 2013

Singapore: Hong Kong Trade Development Council (HKTDC) and Modernized Chinese Medicine International Association (MCMIA ) is organizing 12th International Conference and Exhibition of the M...Read more

Britain's MHRA recalls 16 Wockhardt medicines

Generics |  Regulatory | By BioSpectrum Bureau  | 0 Comment | 12 Jul, 2013

Singapore: UK's drug regulatory body, Medicines and Healthcare products Regulatory Agency (MHRA) has recalled 16 drugs manufactured by Wockhardt Ltd after identifying 'manufacturing deficie...Read more

Chinese planning agency to probe pharma prices

Generics |  Regulatory | By BioSpectrum Bureau  | 0 Comment | 05 Jul, 2013

Singapore: China's primary economic planning agency, the National Development and Reform Commission (NDRC) is in the process of investigating the costs and prices charged by drugmakers. Acc...Read more

Aurobindo recalls epilepsy drug lot in US

Generics |  Regulatory | By BioSpectrum Bureau  | 0 Comment | 25 Nov, 2014

Singapore: India-based Aurobindo Pharma in the US is recalling Gabapentin capsules, USP 300 mg 100-count bottles, at consumer level due to possible stashs of some empty capsules. USFDA has...Read more

Wockhardt restructures quality control team

Generics |  News | By BioSpectrum Bureau  | 0 Comment | 12 Sep, 2013

Singapore: After being rapped by the US FDA and Indian drug regulator for lapses in good manufacturing practices (GMP), Indian drug major Wockhardt has now restructured its quality control ...Read more

GSK officials under criminal investigation in China

Generics |  News | By BioSpectrum Bureau  | 0 Comment | 11 Jul, 2013

Singapore: The Chinese police who have been investigating allegations of bribery against senior executives working at UK's leading multinational pharmaceutical company GlaxoSmithKline in Ch...Read more

Pneumonia kills a 5-year-old child every 30 secs: UN

Generics |  News | By BioSpectrum Bureau  | 0 Comment | 14 Nov, 2013

Singapore: Pneumonia remains the single biggest killer of children under the age of five globally, claiming the lives of more than one million girls and boys every year. However, the good n...Read more

Sanofi files first-of-a-kind suit against FDA

Generics |  News | By BioSpectrum Bureau  | 0 Comment | 13 Nov, 2013

Singapore: Sanofi has filed a lawsuit against the US FDA in hopes of preventing the regulatory agency from releasing packaging information of its newly approved over-the-counter (OTC) aller...Read more

“Chinese generics market has no strategy for international players”

Generics |  Influencers | By BioSpectrum Bureau  | 0 Comment | 17 Nov, 2014

Singapore: In the last one year, Actavis has been aggressive in expanding its presence in Asia and the company was on an acquisition spree. Marking a direct presence in Asia, Actavis launch...Read more

US FDA imposes import alert on Ranbaxy drugs

Generics |  Regulatory | By BioSpectrum Bureau  | 0 Comment | 17 Sep, 2013

Singapore: The US FDA has issued an alert on import of Ranbaxy Laboratories drug products that are manufactured at its plant in Mohali, India. The firm will remain on the import alert unt...Read more

Apollo Pharmacy cautions against Ranbaxy drugs' use

Generics |  News | By BioSpectrum Bureau  | 0 Comment | 10 Jun, 2013

New Delhi: Spelling further problems for India's pharma giant Ranbaxy and its Japanese owners Daiichi Sankyo, Apollo Pharmacy has issued a 'cautionary advisory' against the use of all drugs...Read more

Asian generic companies focus more on market expansion

Generics |  News | By BioSpectrum Bureau  | 0 Comment | 25 Apr, 2015

Singapore: A Frost & Sullivan (F&S) analysis finds that the Asian generic market is expected to grow at a compound annual growth rate of 17-18 percent between 2014 and 2018. The tea...Read more

Taiwan's TWi to independently hit the US market

Generics |  News | By BioSpectrum Bureau  | 0 Comment | 26 Feb, 2015

Singapore: Taiwan-based TWi Pharmaceuticals has decided to sell its products in the US market through its own US subsidiary, instead of the original plan of selling through Teva Pharmaceuti...Read more

Comply or face action: US FDA tells Indian drugmakers

Generics |  News | By BioSpectrum Bureau  | 0 Comment | 29 Jul, 2013

Singapore: With increasing number of non-compliance issues being logged against Indian drugmakers by the US FDA, this time the American regulatory body has instructed the companies to eithe...Read more