Drug Approval | August 17, 2021
Caplin Point Lab's subsidiary receives nod from Brazil's ANVISA for sterile injectable manufacturing site
The approval allows it to market its products in the country
The approval allows it to market its products in the country
Immediate U.S. launch planned for Farxiga®-equivalent diabetes drug; opportunity pegged at $10.2 billion in annual market size
Immediate U.S. launch planned for dapagliflozin-metformin ER tablets; addressable market estimated at $514 millionannually
Wholly owned subsidiary KIMS Swastha signs hospital management and sub-lease deal for 210-bed facility, with option to acquire majority stake later
Rs 66 lakh acquisition will support DNA engineering and novel cell-gene therapy alternatives to conventional chemotherapy
ANDA approval for 100 mg and 150 mg capsules targeting idiopathic pulmonary fibrosis opens access to a $3.76 billion market in USA
The trial, dubbed MALBEC, marks the first in a broader late-phase development push for MK-8748, with a second NVAMD study expected to begin later this year
Certification by TÜV SÜD Product Service GmbH reinforces the company's commitment to globally benchmarked standards in safety, quality, and performance
Lonza will take on technology transfer, process optimization, and cGMP manufacturing, leveraging its global network and expertise in highly potent compounds
The inspection is now closed, and no regulatory action has been recommended
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