Drug Approval | November 03, 2022
Alembic receives USFDA approval for Mesalamine ER Capsules
Mesalamine Extended-Release Capsules are indicated for the maintenance of remission of ulcerative colitis in adults.
Mesalamine Extended-Release Capsules are indicated for the maintenance of remission of ulcerative colitis in adults.
Innovative Capsugel Enprotect capsule can simplify the manufacturing process to accelerate drug development and expedite first-in-human timelines
API platform to comprise of RA Chem Pharma, ZCL Chemicals and Avra Laboratories
His experience covers a wide range of areas including advisory services in the field of accounting, taxation, corporate and commercial laws, and regulatory matters
Most of the new growth Capex investments are happening on the Specialty Chemicals and Nutrition side
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 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 expansion program includes investments in France and the U.S., adding an additional 23,000+ m² of manufacturing footprint.
This is the first injectable product approval from our General Sterile Facility (F-3) which was inspected in August, 2022.
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