Drug Approval | November 04, 2022
Alembic receives USFDA approval for Ketorolac Tromethamine Injection
Ketorolac Tromethamine is advised for the short-term management of moderately severe acute pain in adult patients
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
The observation is procedural in nature and the company will address the observation within stipulated timelines.
Ketorolac Tromethamine Tablets are indicated to relieve moderately severe pain, usually after surgery.
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