Sep 19, 2014 at 17:04 | Source: CNBC-TV18
After this 11-day long audit, where the FDA just took a break just on Sunday; they are expected to wrap up its inspections by the end of the day.
Sep 17, 2014 at 13:53 | Source: PTI
Through an exclusive collaboration agreement in India and of South Asia, Apollo Hospitals would introduce the smartphone enabled, medical grade, FDA-cleared AliveCor Heart Monitor as part of its arrhythmia screening and stroke prevention programme providing patients access to this device, it said in a statement yesterday.
Sep 17, 2014 at 09:58 | Source: Moneycontrol.com
Amoxicillin for oral suspension is the generic equivalent to the reference listed drug product (RLD) of Teva and indicated in the treatment of infections due to susceptible Betalactamase-negative strains of the designated micro-organisms.
Sep 16, 2014 at 14:23 | Source: Moneycontrol.com
"Zydus Cadila has received tentative approval from the US Food and Drug Administration (US FDA) to market (anti-diabetic drug) Glipizide extended release tablets in the strength of 2.5 mg, 5 mg and 10 mg," said the company in its filing.
Sep 12, 2014 at 16:00 | Source: CNBC-TV18
Despite the recent run up in pharma stocks, this week, problems related to the US FDA have made a come back. Jagdish Malkani, member at BSE and NSE believes though the Indian pharmaceuticals industry is a great play, investors should not get carried away with it.
Sep 11, 2014 at 18:48 | Source: CNBC-TV18
The US drug regulator is conducting audits at Sun Pharma's Halol facility in Gujarat. Sun had recalled multiple products made in this facility. Could this spell further trouble for Sun Pharma? Pharma Asia News India bureau chief Vikas Dandekar spoke with CNBC-TV18s Senthil Chengalvarayan and Sonia Shenoy to discuss the development.
Sep 11, 2014 at 09:56 | Source: Moneycontrol.com
Sources say Sun Pharma was taken by surprise when a team of 5 inspectos of United States Food and Drug Administration (US FDA) walked in on Monday morning for inspection that is still ongoing.
Sep 10, 2014 at 21:48 | Source: CNBC-TV18
The US drug regulator is conducting a surprise audit at Sun Pharma Halol facility in Gujarat. The audit started on Monday and is still going on, sources told CNBC-TV18s Archana Shukla.
Sep 01, 2014 at 12:03 | Source: Moneycontrol.com
Wockhardt's New Drug Discovery Programme in Anti-Infective research received a major boost after two of its drugs, WCK 771 and WCK 2349, received the coveted Qualified Infectious Disease Product (QIDP) status from the US FDA.
Sep 01, 2014 at 11:06 | Source: CNBC-TV18
"Marketing partner in the USA, Mylan Inc has filed an abbreviated new drug application (ANDA) for a three-times-a-week generic Copaxone (glatiramer acetate injection, 40 mg/ml) and has been accepted by the US Food and Drug Administration (US FDA)," said the company in its filing.