November 24, 2014 14:40 (IST)
Dr Reddy's Abbreviated New Drug Application (ANDA) is approved by the United States Food & Drug Administration (USFDA), DRL said in a statement today.
November 23, 2014 16:17 (IST)
The government is working on bringing various departments and agencies dealing with the pharmaceuticals sector under a single authority for better coordination and effectiveness.
November 18, 2014 19:59 (IST)
The FDA told Ranbaxy this month that it believed its decisions to grant the company tentative approvals for copies of Nexium and Roche AG's antiviral Valcyte were "in error", after it found that Ranbaxy's plants at the time were not compliant with the FDA's manufacturing quality standards.
November 17, 2014 18:22 (IST)
As per the information available on the USFDA website, Sun Pharma Global Inc, a unit of the company, is recalling the drug for failing "dissolution specification".
November 14, 2014 15:08 (IST)
The Competition Commission of India (CCI) is likely to take the final decision in the $4-billion Sun Pharma-Ranbaxy deal by the end of this month, the fair trade watchdog's chairman, Ashok Chawla, has said.
November 12, 2014 21:42 (IST)
As countries are increasingly focusing on affordable healthcare, Indian pharmaceutical firms are well positioned for global growth, according to a report by global rating agency Standard & Poor's (S&P).
November 12, 2014 12:15 (IST)
Cadila Pharmaceuticals is the latest Indian drugmaker to face US regulatory rebuke, as the FDA intensifies its scrutiny of the generic drugmakers.
November 12, 2014 10:47 (IST)
Aurobindo said the deal with Chatsworth, California-based Natrol, which sells vitamins and supplements as well as diet and weight management products, will help the company expand its over-the-counter products business in the United States.
November 12, 2014 08:04 (IST)
India's $15 billion pharmaceutical industry, which has been hit by a spate of regulatory sanctions in the past year due to concerns about production processes, supplies about 40 per cent of generic and over-the-counter drugs to the United States.
November 11, 2014 22:49 (IST)
Drug firm Venus Remedies has received approval from the Swiss drug authority - Swissmedic - to market in the country its generic injectable antibiotic meropenem used for treating infections.
November 10, 2014 22:54 (IST)
The Commerce and Industry Ministry has circulated a draft Cabinet note for inter-ministerial comments on liberalising foreign direct investment (FDI) policy in medical devices.
November 06, 2014 21:31 (IST)
The government on Thursday said it is seeking to increase sales of India's ayurvedic and other traditional therapies in the estimated $100-billion global market for alternative medicine and plans to set up a new quality control regulator.
November 06, 2014 16:57 (IST)
The US Food and Drug Administration (FDA) has revoked a tentative approval for Ranbaxy Laboratories to make a cheap copy of AstraZeneca's heartburn drug Nexium, after its Indian plants were banned over quality control issues.
November 06, 2014 14:35 (IST)
The Competition Commission of India (CCI) is likely to finalse this month its decision on the $4-billion Sun Pharma-Ranbaxy deal - the first M&A (merger and acquisition) transaction to have gone through public scrutiny amid concerns of its adverse impact on fair competition in the market.
November 05, 2014 16:41 (IST)
Glenmark Generics Inc (GGI) has been granted the final abbreviated new drug approval (ANDA) from the United States Food and Drug Administration (USFDA) for Omeprazole Delayed Release Capsules, their generic version of Prilosec by AstraZeneca, a company statement said.
November 03, 2014 23:43 (IST)
Drug firm Lupin Ltd on Monday said it has received approval from the US Food and Drugs Administration (FDA) to market a generic version of GD Searle LLC's Celebrex capsules, used to treat arthritis, in the American market.
November 03, 2014 19:32 (IST)
The company's consolidated net profit for the quarter ended September was Rs 3.63 crore, compared with a profit of Rs 139 crore a year earlier. Net sales fell 21 percent to Rs 948 crore.
November 02, 2014 19:37 (IST)
The Commerce and Industry Ministry is looking into the merit of Cipla's demand for revocation of patents of Swiss drug major Novartis for respiratory drug Indacaterol citing the need for public health access.
November 02, 2014 17:32 (IST)
Drug maker Dr Reddy's Laboratories has said it may file two new drug applications (NDA) with the FDA by the end of next year.
October 31, 2014 17:11 (IST)
Drug firm Pfizer Inc on Friday said the Bombay High Court has approved the amalgamation of Wyeth Ltd with the company.