US FDA completes audit of Dr Reddy’s Louisiana-based facility
No Form 483 was issued at the end of the inspection, the company said in a regulatory filing, the company said
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US FDA
Aurobindo Pharma net surges 39.5 per cent to Rs 636 crore
Revenues stood at Rs 5,444.6 crore against Rs 4,250.3 crore and witnessed a strong growth of 28.1 per cent
Aurobindo Pharma has…
Roche says Tecentriq prevents disease worsening or death in patients with advanced bladder cancer
Roche is evaluating treatment in combination with other medicines for early, advanced forms of disease
Granules India receives US FDA approval for Amphetamine Sulfate tablets
The product is generic version of Arbor Pharmaceuticals LLC's Evekeo tablets in similar strength
Natco Pharma receives EIR from US FDA
The EIR was issued for its Kothur facility in Telangana
Lupin gets EIR from USFDA for Aurangabad facility
The facility was inspected by the US Food and Drug Administration (US FDA) between May 6-15, 2019, Lupin said in a BSE filing
Warning letter woes: Dr Reddy’s expects FDA inspection of AP plant by year-end
The company's API plant at Miryalaguda was given an Establishment Inspection Report (EIR) in 2017 resolving the earlier warning…
Alembic Pharma gets tentative nod from USFDA for glycemic control drug
Quoting IQVIA sales data, the company said, Dapagliflozin Tablets, have an estimated market size of USD 1.7 billion for 12 months,…
Zydus Cadila launches insomnia drug in the US market
The drug will be manufactured at group's formulations manufacturing facility at SEZ, Ahmedabad
US FDA completes inspection of Strides Pharma Bengaluru plant
The company's facility in Bengaluru underwent a United States Food and Drug Administration (US FDA) inspection that ended on May…