The Mumbai-based pharmaceuticals company said the US health regulator had conducted an inspection at the Ankleshwar facility from December 5 to December 9.
Alkem Laboratories said it will put together a detailed response with adequate corrective and preventive measures to address the FDA's observations and the same is proposed to be filed within the time line stipulated by the US regulator.
In August this year, Natco Pharma received a final approval for its abbreviated new drug application for generic versions of Tamiflu oral capsules from the US drug regulator.
Sun Pharma was earlier issued a warning letter by the USFDA for its Halol facility in December 2015.
For Wockhardt, decline in revenues from the US markets caused revenue growth to decline at a CAGR of 7.2 per cent over FY2013-16 and negative 9 per cent YoY in the first half of 2016-17.
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.