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The decision comes two months after ET reported how payment delays and regulatory hurdles had forced companies such as Cipla to stop production of these drugs.
An ANDA contains data that provides for the review and ultimate approval of a generic drug product by the United States Food and Drug Administration (USFDA).
"The company's manufacturing facility at Baddi has received an Establishment Inspection Report from the USFDA", Cadila Healthcare said in a BSE filing today.
Zydus Cadila has received final approval from the US Food and Drug Administration (USFDA) to market the Mirtazapine orally disintegrating tablets USP in strengths 15mg, 30mg and 45mg, the company said in a BSE filing.
The Gujarat group has more than 115 approvals and has so far filed over 300 abbreviated new drug applications (ANDAs) since it commenced filings in 2003-04.
By utilising the network of SastaSundar, Rohto will be expanding its presence in India, which is a key emerging market for the company, Lekh Raj Juneja said.
Neksium was launched in India in the year 2006 and has developed strong equity with prescribers as a leading, high quality product in the Anti-Peptic Ulcerant space.
SastaSundar.com has been built upon the online to offline model of healthcare delivery. Having a GMV of 151 crores as of March 2017, Sasta Sundar delivered close to 17 lacs orders.
"The formulations facility in Bangalore was recently inspected by the US FDA. The company has been issued a Form 483 with 3 observations," Strides Shasun said in a BSE filing.
Several pharma cos including some of the leading ones have over the years steadily transferred most of their IPs outside India and reduced their tax burden in the country.
Quoting IMS sales data, Strides Shasun said the US market for memantine hydrochloride tablets USP, 5mg and 10 mg is approximately USD 60 million.
The 59-year old global health leader said that there were several "pre-qualified" generic medicine companies in India producing quality medicines.
The FDA filing acceptance follows the acceptance of the regulatory filing of tildrakizumab by the European Medicines Agency (EMA) in March 2017.
The drug will be produced at the group's formulation manufacturing facility at the pharma SEZ in Ahmedabad, it added.
Greg Jefferys, 62, is a Hepatitis C survivor and has become a Ron for several who suffer from the potentially fatal viral infection.
IHH is competing with a private equity consortium of TPG and General Atlantic to acquire controlling stakes in both Fortis Healthcare and Fortis Malhar.
| Company Name | Latest | Change | %Change | Volume |
|---|---|---|---|---|
| Nifty Pharma | 9174.6 | -55.15 | -0.59 | 0 |
| Ranbaxy Laboratories | 859.8 | 45.8 | 5.63 | 5415702 |
| Sun Pharmaceutical Industries | 504.3 | -8.5 | -1.66 | 4813209 |
| Brabourne Enterprises Ltd.[Amalgamated] | 10.05 | 0 | 0 | 8896 |
| Lupin | 1151 | -5.2 | -0.45 | 1352183 |
| Cadila Healthcare | 489.5 | -1.1 | -0.22 | 1941829 |
