The United States Food and Drug Administration (USFDA) inspected the Halol facility from November 17, 2016 through December 1, 2016, Sun Pharma said in a BSE filing.
The company manufactures active pharmaceutical ingredients (APIs) and intermediates for generics among others at the manufacturing plant.
The latest notice, a Form 483, was issued to Sun after the FDA completed an inspection of the Halol plant on December 1, the company said.
The latest notice, a Form 483, was issued to Sun after the FDA completed an inspection of the Halol plant on December 1.
The tablets are generic version of Allergan Sales LLC's Norco tablets in the same strengths and the product will be launched shortly, Lupin said.
The tablets are indicated for acute treatment of migraine in adults.
Shares of Strides Shasun were trading at Rs 1,077 apiece, up 0.13 per cent, from its previous close on the BSE
Lupin had earlier collaborated with Lilly in July, 2011 to promote and distribute Lilly's Huminsulin range of products in India and Nepal.
The company has also decided to discontinue the manufacturing of current Corex cough syrup formulation.
Actelion Pharmaceuticals Ltd makes high blood pressure medicines that treat arteries in the lung and around the heart.
Aurobindo Pharma has inked a pact to acquire select commercial products in France from Teva for an undisclosed amount.
Moody's findings are part of a report titled "Indian Pharmaceutical Companies -- A Deep Dive", co-authored by Chaubal and Beketova.
Pharma major Lupin has received tentative approval for its Abacavir Sulfate and Lamivudine tablets from the USFDA to market generic version of ViiV Healthcare company's Epzicom tablets.
Bupropion Hydrochloride extended release tablets USP (XL) in the strength of 300 mg is indicated for the treatment of major depressive disorder.
There will be no change in the shareholding pattern as business is transferred to a wholly owned subsidiary for cash consideration of Rs 69.3 crore, Cadila Healthcare said.
New Delhi: In line with global trends in thepharmaceuticals sector, the focus of domestic drug firms on acquisitionsto consolidate their position will limit deleveraging for thetime being, rating agency Fitch has said. "The ongoing focus of the top Indian pharma companies' onselective acquisitions to limit deleveraging over the shortterm," Fitch said in '2017 Outlook: Indian Pharmaceuticals'. These acquisitions will help the companies to consolidate their positioning, with deleveraging likely only over the medium term as the acquired businesses contribute incremental earnings, it added. "Many firms (including Sun, Dr Reddy's, Lupin and Cipla) have actively pursued acquisitions...in order to augment their existing drug portfolios and solidify their presence in both existing and new geographies," Fitch said. It pointed out that domestic pharma market would continue to grow on account of higher consumer spending, urbanisation, improving access to medical facilities and health insurance, and the growing prevalence of lifestyle diseases. According to Fitch, the regulatory compliance remains the keyfor growth and it "expects pharma companies with a strongregulatory compliance track record to benefit from a fasterpace of Abbreviated New Drug Application (ANDA) approvalsunder GDUFA in the US market". "Drug approval by USFDA to Indian drug companies hasalmost doubled to over 200 in FY15-FY16 over the prior period,and Indian pharma companies now represent about 30 per cent(by volume) and 10 per cent (value) of the $70 billion -80 billion US generics market," Fitch said. Furthermore, the US drug regulator aims to implement the GDUFA IIframework from October 2017, which gives some guidance on afurther reduction in approval timeframes. "This will benefitIndian pharma companies in boosting their presence in the US,"it added.
FDEC-India has been established by Sun Pharma as part of its corporate social responsibility initiative.
Both US presidential candidates have argued in favour of allowing the US government's Medicare programme, which accounts for over 20 per cent of total US drug spend, to directly negotiate drug prices with manufacturers.
The product has been launched in four strengths 5mg20mg, 5mg40mg, 10mg20mg and 10mg40mg, Ajanta Pharma said.