The company's current portfolio consists of 112 products authorised for distribution in the US marketplace and 63 ANDA pending approval with the US regulator.
Olmesartan Medoximil tablets, a generic version of Daiichi Sankyo's Benicar, are indicated for the treatment of hypertension, along with other anti-hypertensive agents to lower blood pressure, it added.
The National Drug Pricing Regulator has also fixed the retail prices of 29 formulations.
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.