Establishment Inspection Report is provided Upon completion of an inspection with details of inspectional findings.
scPharmaceuticals Inc is a United States-based pharmaceutical company developing a portfolio of transformative pharmaceutical products for subcutaneous delivery.
The Department of Pharmaceuticals has in a notification put bare metal stents and drug eluting stents (DES) in the Schedule I of DPCO 2013.
The $32-billion generic-driven Indian pharma industry is eyeing a sea of opportunities as global demand for safe and quality drugs rises.
Sun Pharma Advanced Research Company today said the US health regulator has not approved its new drug application for Xelpros, a preservative-free eye drop.
Odomzo was approved by the USFDA in July 2015. It is indicated for the treatment of adult patients with locally advanced basal cell carcinoma.
Jubilant Cadista Pharmaceuticals Inc, part of the Jubilant Group, is recalling over 1,500 bottles of glucocorticoid Methylprednisolone tablets in the US market due to incorrect labelling.
As per the FDA, a class III recall is initiated in "a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This transaction gives the company access to local manufacturing capability across multiple dosage forms in Russia,
"Tricor tablets and generic equivalents had US sales of approximately $307 million for the 12-month period ending October 2016, according to IMS Health," Cipla said.
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.
Itraconazole capsules had an estimated market size of $42 million for twelve months ending December 2015.
Claris Injectables manufactures and markets generic injectables across multiple delivery systems, markets and therapeutic segment including anesthesia, anti-infectives and others.
Lupin said it has received final approval to market its Desoximetasone ointment USP, 0.05 per cent, from the US health regulator.
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.