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GLENMARK US FDA
USFDA issues import alert on Glenmark Pharma's Baddi plantThe US Food and Drug Administration inspected the facility in June 2022 and subsequently placed it under "Official Action Indicated" status.
Glenmark Pharma gets 7 observations from USFDA for Baddi unitGlenmark said its Baddi unit contributes approximately 10 per cent of the revenue of the US sales.
Glenmark gets US FDA nod for high blood pressure medicineGlenmark’s current portfolio consists of 119 products authorized for distribution in the US and 66 Abbreviated New Drug Approvals (ANDAs) p...
Glenmark's Ankleshwar plant gets EIR report from USFDA"The EIR is issued by the FDA only if it finds the facility to be deemed acceptable," the company said in a BSE filing.
Glenmark Pharma gets USFDA nod for two generic drugsQuoting IMS data, Glenmark Pharma said the approved product has an estimated market size of $74.1 million for the 12 months ended November ...
Dr Reddy's launches insomnia drug in US; Glenmark gets FDA nodThe company has started selling 1 mg, 2 mg and 3 mg tablets of Eszopiclone, a generic version of Lunesta, a sedative drug that is used for ...
Glenmark recalls three drugs from US marketGlenmark Generics is recalling multiple lots of three of its drugs from the US market due to "odd smell", according to US FDA.
- Glenmark receives ANDA approval for its contraceptive pills
Glenmark Generics Inc., USA, a subsidiary of Glenmark Glenmark on Monday announced they have been granted final approval for their abbrevia...
- Glenmark gets a boost in cholesterol drug battle with Merck
Glenmark Pharmaceuticals has gained the upper hand in a legal battle against Merck over a cholesterol control pill after a US court rejecte...
- Glenmark's NDA gets US FDA nod
Drug firm Glenmark on Wednesday said US Food and Drug Administration (FDA) has accepted its new drug application (NDA) for pain killer oxyc...
- Glenmark gets first nod for Zetia generic
Glenmark Pharmaceuticals has got tentative approval from the USFDA for the generic version of Schering Plough and MSP Singapore Company LLC...
- Glenmark confirms patent challenge of fluticasone lotion
Glenmark Generics Ltd's US subsidiary confirmed Nycomed US filed a patent infringement lawsuit on Dec 12, 2008, in the US District Court, E...
- Glenmark to start phase I clinical trials of GBR 500 in US
Drug firm Glenmark pharmaceuticals on Friday said it will file an application with American health regulator US Food and Drug Administrator...
- Glenmark confirms Abbott suit against Tarka generic
Glenmark Pharmaceuticals has confirmed that Abbott has filed a suit in the US District Court of New Jersey on December 7, seeking to preven...
- Glenmark gets US nod for drug trials
Ending a long wait for Glenmark Pharmaceuticals, the US Food and Drug Administration (FDA) finally gave its nod to the Indian drugmaker to ...
- Glenmark receives FDA nod to market epilepsy drug
Glenmark Pharma rose 1.6% to Rs 415 on receiving final approval from the US Food and Drug Administration for marketing Oxcarbazepine tablet...
- Glenmark gets nod to sell Zofran generic in US
Glenmark Pharmaceuticals has received final approval to market a generic version of GlaxoSmithKline’s popular anti-emetic drug Zofran, that...