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
Glenmark’s Sodium Phenylbutyrate Tablets USP, 500 mg, will be distributed in the U.S. by Glenmark Pharmaceuticals USA.
This is the first injectable product approval from our General Sterile Facility (F-3) which was inspected in August, 2022.
The company has been ranked 8th on the list this year for three key attributes: ‘innovative leader in the industry’, ‘is socially responsible’ and ‘has loyal employees’
According to IQVIA sales data for the 12-month period ending September 2022, the Gilenya Capsules, 0.5 mg market achieved annual sales of approximately US $1.8 billion
The participants discussed the latest developments under ABDM that shall enable true interoperability in the health sector and how effective adoption of ABDM can pave the way towards Universal Health Coverage
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.
NFIL’s ambition is to reach revenues of US$100mn from CDMO by FY25.
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
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