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Laurus Labs has received Form 483 with zero observations for Unit 2 (the formulations unit).
The United States Food and Drug Administration (USFDA) has successfully completed the audit, without any observations .i.e Zero 483 for its Unit 2. This inspection was carried out from February 23-March 1, 2018.
Further, the company has also received its maiden approval from USFDA, for Tenofovir Disoproxil Fumarate tablets 300mg. This tablet is used for treating HIV-1 infection in adults and pediatric patients 2 years of age and older.
