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Leuprolide Acetate Injection Depot contains 22.5 mg of leuprolide acetate for 3- month administration given as a single dose injection.
The drug will be manufactured at the group's injectable manufacturing facility at Jarod, near Vadodara, India
Government of India has granted a patent for invention entitled "An improved safe process for the preparation of Sartan drugs of Formula I".
Famotidine Injection is indicated to treat ulcers of the stomach and intestines and to prevent intestinal ulcers from coming back after they have healed
The company had responded to the agency and carried out the required corrective actions.
Doxycycline Capsules (RLD Oracea) had estimated annual sales of US $215 million in the US
The drug will be manufactured at the group’s formulation manufacturing facility at Ahmedabad SEZ, India
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
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.
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