Homegrown pharma major Lupin Ltd on Monday announced the launch of generic version of its voriconazole tablets and oral suspension used for treatment of fungal infectinos in children.
Currently, Ocular is developing Seciera for treating dry eye disease, the city-based company said, adding the drug is currently in Phase-3 confirmatory clinical trials.
Claris Injectables manufactures and markets generic injectables across multiple delivery systems, markets and therapeutic segment including anesthesia, anti-infectives and others.
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.
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.