Drug Approval | November 08, 2022
Zydus receives EIR with VAI from USFDA for Moraiya facility
The USFDA has determined that the inspection classification of the facility is Voluntary Action Indicated (VAI)
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
Ketorolac Tromethamine is advised for the short-term management of moderately severe acute pain in adult patients
Mesalamine Extended-Release Capsules are indicated for the maintenance of remission of ulcerative colitis in adults.
This is the third major regulatory milestone for the vaccine candidate following acceptance of regulatory submissions in Europe and Japan
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.
This is the first injectable product approval from our General Sterile Facility (F-3) which was inspected in August, 2022.
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
Acetaminophen injection had annual sales of US $72 million in the United States according to IQVIA data
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