Cadila Healthcare has received US Food and Drugs Administration approval for an antibacterial injection from its Moraiya plant, indicating an end to its regulatory problems.
With no regulatory overhang, the drug maker expects approvals to 40 products, including some high-value speciality drugs in the US in FY18. The US market contributes around 40 per cent to the company's revenue. The Moraiya plant, which contributes around 60 per cent to its US sales, was served a warning letter in December 2015 which delayed product approvals and cut earnings estimates.
The company successfully cleared an FDA audit in February with zero adverse