Glenmark Pharmaceuticals is asking back to about 1.5 million bottles of a generic drug in the US market, which is used in the treatment of concentration and the treatment of over -activation disorder (ADHD). The US health regulator gave this information. Glenmark Pharmaceuticals Inc., USA, a Mumbai -based drug manufacturer, is asking back to about 14.76 lakh bottles of several atomoxetine capsules.
The US Food and Drug Administration (USFDA) said in its latest enforcement report that the company is asking back to the affected consignment due to “CGMP deviation”. The decision was taken due to the N-Nitroso Atomoxetine impurities being found more than the USFDA’s fixed limit. The drug regulator stated that Glenmark Pharmaceuticals Ink in New Jersey, USA is asking back to the product made in India with a capacity of 10 mg to 100 mg.
Read Business Standard’s December 2024 report
Business Standard reported in its report in December 2024 that according to the US health regulator, drug manufacturers Arbindo Pharma, Glenmark and Zidas are calling back products in the US market due to manufacturing issues.
American subsidiary of Glenmark Pharmaceuticals is calling back around 90,000 bottles of DILTIAZEM Hydrochloride Extended-Release Capsules (multiple powers) in the US market.
The US health regulator said that Glenmark Pharmaceuticals Inc. in New Jersey, USA “GMP Devilations: The interim limit recommended by FDA: The presence of N-Nitroso-Dasthal-Diltiazem impurities” than the interim limit recommended by FDA. Used to be.
How were the results of the second quarter of Glenmark
The integrated net profit of Glenmark Pharmaceuticals was Rs 354.49 crore in the second quarter ended September of the current financial year. The net profit of the company was Rs 180.3 crore in the same quarter of the last financial year.
Glenmark Pharmaceuticals said in a notice sent to the stock market that its operational income in the quarter was Rs 3,433.8 crore, which was Rs 3,207.37 crore in the same quarter of the previous financial year. The company’s total expenditure in the September quarter was Rs 3,000.64 crore, which was Rs 3,008 crore in the same quarter of the previous financial year.
In February 2025, the Settlement Agreement of $ 7 Million was announced
On February 24, 2025, Glenmark Pharmaceuticals rose 2.71% to Rs 1,335.50, when the company announced a $ 7 million settlement agreement. This edge by the company Humana Inc., Center Corporation and Kaiser Foundation Health Plan, Inc. With a $ 7 million settlement reached the agreement with it.
These cases were based on allegations of competition involving cholesterol-reducing drug Zetia and combination drug Vytorin. The cases filed in the Eastern District Court of Virginia (US) alleged that Glenmark signed an anti-effective agreement with Shering Corporation and MSP Singapore Company LLC in 2010, belonging to the patent of Azetimibe, an active component of Zetia. In this case Glenmark and MRCK & Co., Inc. He was defendant and accused of violation of antitrust and consumer protection laws.
Glenmark had already signed a compromise with other plaintiffs in 2023, but these three companies (Humana, Cennene and Kaiser) remained out at that time. Glenmark agreed to an agreement of $ 7 million to avoid long legal process and end the dispute. However, the company clarified that the agreement is not to accept any responsibility or wrongdoing and it rejects all the allegations.
Glenmark pharmaceuticals profile
Glenmark Pharmaceuticals is a global innovation-based pharmaceutical company that works in specialty, generic and OTC (over-the-counter) business. The company’s 11 state -of -the -art manufacturing units extend over 4 continents and operate in more than 80 countries.
(With agency input)
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First Published – March 2, 2025 | 5:15 PM IST
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