USFDA concludes inspection of Unichem Lab's Roha facility
The inspection was a post-approval inspection and successfully concluded.
FDA pulls up Aurobindo Pharma for 'repeated' failures in CGMP
The FDA recently issued a letter warning the drug- makers unit X1 in Srikakulam...
Indoco Remedies gets EIR from USFDA for 2 plants in Goa
"We are happy to receive the EIR in less than two months from the date of inspection,...
Audit of Laurus Labs completed by USFDA without objections
The maiden United States Food and Drug Administration (USFDA) audit for Laurus Labs was successfully completed without Form 483 .
Dr Reddy’s Labs down after USFDA observations
Will address observations comprehensively within the stipulated timeline, DRL said.
Unichem Laboratories gets USFDA nod for hypertension management drug
The approved product is a generic version of Hygroton tablets, 25 mg and 50 mg of Sanofi Aventis US, LLC.
USFDA issues 6 observations to Natco Pharma's API facility near Hyderabad
The United States Food and Drug Administration (USFDA) conducted inspection at Kothur facility between August 5-9, 2019.
Warning letter woes: Dr Reddy's expects FDA inspection of AP plant by year-end
USFDA had issued warning letter in November 2015 relating to Current Good Manufacturing Practice deviations at DR Reddy's API manufacturing facilities at Srikakulam.
USFDA issues 9 observations to Natco Pharma's Kothur facility
"At the end of the inspection, the facility received 9 observations, with no repeat observations and mostly procedural in nature," Natco Pharma said in a BSE filing.
Alembic Pharma gets USFDA nod for Parkinson's disease treatment drugs
Quoting IQVIA sales data, the company said the two products had an estimated market size of USD 24 million for 12 months ended December 2018.
Lupin's Goa facility may face regulatory action, says USFDA
The USFDA has stated that it may withhold approval of any pending applications or supplements in which this facility is listed," it added.
Alembic Pharma gets USFDA nod for overactive bladder treatment drug
The company has received approval from the USFDA for its abbreviated new drug application (ANDA) Solifenacin Succinate tablets in the strengths of 5 mg and 10 mg.
Swarms of bugs, missing data plague firms now making heart drug
Last month, the FDA posted a list of 43 versions of valsartan and similar drugs that don’t contain carcinogens.
Stock pick of the week: Jubilant Life Sciences offers long-term growth say analysts
Sharp stock price correction, strong growth rates, focus on the growing speciality pharma segment, a bouquet of niche products, among other things, have made it top pick.
Dr Reddy's launches generic testosterone gel in US market
The company's testosterone gel 1.62 per cent, which is a therapeutic equivalent generic version of AndroGel 1.62 per cent of AbbVie Inc, was approved USFDA.
Copyright © 2019 Bennett, Coleman & Co. Ltd. All rights reserved. For reprint rights: Times Syndication Service