The drug will be manufactured at the group’s formulation manufacturing facility at Ahmedabad SEZ, India
Doxycycline Capsules (RLD Oracea) had estimated annual sales of US $215 million in the US
The acquisition is for an enterprise value of Rs. 218 crores
The USFDA has determined that the inspection classification of the facility is Voluntary Action Indicated (VAI)
Drospirenone Tablets (RLD Slynd) had estimated annual sales of US $141 million in the US
API platform to comprise of RA Chem Pharma, ZCL Chemicals and Avra Laboratories
The voluntary program is the first time the FDA will allow excipient manufacturers to obtain review of certain novel excipients prior to their use in drug formulations.
The company is committed to addressing the observations at the earliest, and gaining approval for injectable manufacturing for the US
The company currently supplies one product to the US market that contributes low- single digit revenue to Jubilant Pharmova revenue
Ketorolac Tromethamine Tablets are indicated to relieve moderately severe pain, usually after surgery.
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