The company is recalling the affected lot due to "CGMP Deviations", the US Food and Drug Administration (USFDA) said in its latest Enforcement Report. The recall is due to "presence of N-Nitroso ...

The company is recalling the affected lot due to "CGMP Deviations", the US Food and Drug Administration (USFDA) said in its latest Enforcement Report. The recall is due to "presence of N-Nitroso ...

New Jersey-based Glenmark Pharmaceuticals Inc, USA is recalling the made-in-India product in strengths ranging from 10 mg to 100 mg, USFDA stated.

Granules India Ltd’s Gagillapur facility receives Warning Letter from US FDA after an inspection in August 2024. The Warning Letter is dated February 26, 2025 and the facility continues to ...

Emcure Pharmaceuticals announced that the United States Food and Drug Administration (USFDA) had conducted a current Good Manufacturing Practices (cGMP) inspection of Company's API manufacturing ...

(Reuters) -The U.S. Food and Drug Administration confirmed on Thursday that a meeting of its independent advisory panel to discuss the composition of this year's flu vaccine had been canceled and ...

"We are addressing the observations comprehensively and will respond to the USFDA within the stipulated time frame, Emcure Pharmaceuticals said. As per the USFDA, Form 483 is issued to a firm's ...

Rafsha Marine Services Private Limited is an Indian Non-Government Company. It's a private company and is classified as'company limited by shares'. Company's authorized capital stands at Rs 1.0 lakhs ...

Chennai: Caplin Steriles Limited, a Subsidiary Company of Caplin Point Laboratories Limited, has been granted final approval by the United States Food and Drug Administration (USFDA) for its ...

Meeting of US FDA Vaccine Advisers Canceled, Committee Member Says By Dan Levine and Michael Erman (Reuters) -A meeting of a committee which advises the U.S. Food and Drug Administration on ...

(Reuters) -A meeting of a committee which advises the U.S. Food and Drug Administration on vaccine policy has been canceled, a committee member told Reuters, the second such disruption to a federal ...