Zydus to commence supplies to US from facility at Ahmedabad SEZ

Receives approval for Doxycycline Capsules USP

In what can be termed a shot in the arm for Ahmedabad-based pharma major Zydus Cadila, it has received approval from the US drug regulator to market an anti-bacterial drug doxycycline capsules from its formulation facility at the Ahmedabad special economic zone (SEZ). This is the first product from the SEZ that received approval to be exported to the US.

In a press statement, the company said that Zydus Cadila has received approval from the US Food and Drug Administration (USFDA) to market doxycycline Capsules USP, 50 mg, 75 mg, and 100 mg. The drug falls in the anti-bacterials segment. With this first approval, the group will now commence supplies to the US market from its formulation manufacturing facility located at the SEZ in Ahmedabad.

 
The group now has 102 approvals and has so far filed over 280 abbreviated new drug applications (ANDAs) since the commencement of the filing process in FY04.
 

As such after the company's formulations site at Moraiya (near Ahmedabad) and active pharmaceutical ingredients (API) site Zyfine had received warning letters from the USFDA. While Zyfine was not supplying any API to the US, the Moraiya site accounted for nearly 60% of the company's US business.

Zydus had promptly initiated site transfers for several of its key products from the Moraiya site. It had mentioned that supplies to the US would commence soon from other facilities; its Baddi and Ahmedabad SEZ facilities are approved by the USFDA. Product approvals from the SEZ facility were expected.

Analysts feel that product approvals from the SEZ facility would be key to driving the company's US business (which is pegged at $500 million last fiscal). The company has already initiated transfers of generic filings as a risk mitigation strategy.