Drug Approval | December 23, 2022
Diclofenac Sodium Topical Solution, 2% w/w (RLD PENNSAID) had estimated annual sales of US $509 million in the US (IQVIA MAT October 2022)
The inspection of the facility resulted in issuance of a Form-483 with eight observations each for the Drug Product facility and API facility at the site
Nikon’s newly launched product AXR Point scanning confocal microscope provides “World’s largest Field of View” of 25mm in one single shot
Doxycycline Capsules (RLD Oracea) had estimated annual sales of US $215 million in the US
Drospirenone Tablets (RLD Slynd) had estimated annual sales of US $141 million in the US
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
Paliperidone Extended-Release Tablets (RLD Invega) had estimated annual sales of US $112 million in the US
Mirabegron Extended-Release Tablets, 25 mg and 50 mg, had estimated annual sales of US $2.4 billion in US
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