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The USFDA placed Glenmark's Baddi unit under an import alert 66-40 in October last year.
The United States Food & Drugs Administration has granted an exception to Glenmark Pharma's Baddi facility for the supply of Atovaquone Oral Suspension USP 750mg / 5 to the US market.
Atovaquone is used in the treatment of Pneumocystis Pneumonia in adults and children aged 13 or older, who cannot tolerate other medicines. The drug is sold under the brand name Mepron.
Glenmark's Baddi unit has been granted an exception as the USFDA placed it under an import alert 66-40 in October last year. An import alert 66-40 is issued when the company is not operating in conformity with current Good Manufacturing Practices (GMP).