Citing IMS MAT September 2016 data, the company said MS Contin ER tablets had sales of USD 282.9 million in the US market.
US President-elect Donald Trump on Wednesday said pharmaceutical companies are "getting away with murder".
Last year, the USFDA had put the company's Ratlam-based active pharmaceutical ingredients(API) facility under import alert.
Lankau has over 30 years of management experience in developing and commercialising pharmaceutical products.
Last month, the US regulator had made five observations after inspection of the company's manufacturing plant at Visakhapatnam.
Aurobindo Pharma on Saturday said it has inked a binding agreement, through its wholly-owned subsidiary Agile Pharma BV Netherlands, to acquire Generis Farmaceutica SA from Magnum Capital Partners for a total consideration of 135 million euros.
Natco and Breckenridge filed their ANDA with a Paragraph IV certification on the first-to-file date and expect to share 180-day exclusivity with other ANDA first filers,
USFDA has already banned import of products from the facility into the US market since August 5, 2016.
At day's high, Jubilant Life Sciences shares recorded gains of more than 13 per cent in two trading sessions.
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.