The first quarter of the calendar year 2016 has turned out to be a good one for Cadila Healthcare as far as drug approvals for the US market goes. The company today said that it has received the final approval from the US drug regulator to market an anti-viral drug Acyclovir capsules (200 mg). This would be the third drug approval for the US markets for the Group this year apart from a tentative approval.
The drug would be produced at the formulations manufacturing facility at the Ahmedabad special economic zone (SEZ). The group now has more than 100 approvals and has so far filed over 280 ANDAs since the commencement of the filing process in FY03-04.
Earlier during this year, the company had received tentative approval from the US Food and Drug Administration (USFDA) to market Clofarabine Injection (20mg/20ml vials) in March. Zydus had received another final approval from the USFDA in March itself, for anti-diabetics drug Glyburide and Metformin Hcl tablets. This, however, would be manufactured at its Baddi site. In February Zydus' anti-bacterial drug doxycycline capsules had received nod from the US regulator.This was the first product from the SEZ that received approval to be exported to the US.
After the company's formulations site at Moraiya and API site Zyfine had received warning letters from the USFDA in the beginning of the year, the company had promptly initiated site transfers for several of its key products from the Moraiya site.