The portfolio consists of liquids and immediate release solid orals which are in the therapeutic segment to treat infections associated with UTIs
The FDA issued Form 483 with one observation related to building and facility management
The Subsidiary has received one inspectional observation in Form 483
This partnership encompasses dossier licensing, bulk product supply, and the licensing of ZIM Labs’ proprietary Oral Thin Film technology platform, ThinOral
Dr Reddy’s said scheme of amalgamation was carried with adherence to all the legal requirements including tax laws
Dimethyl Fumarate Modified Release Capsules are indicated for the treatment of relapsing forms of multiple sclerosis
Alkem Medtech to acquire 100% stake of Bombay Ortho
This termination of Agreement will not have any significant impact on the company and/or its subsidiaries or its financials
The company will provide the necessary response on these observations to USFDA within stipulated 15 days
The basket acquired, comprises of 13 ANDAs, which are approved by the USFDA and 1 ANDA, which is pending approval from the USFDA
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