Drug Approval | December 23, 2022
36.4% of patients with diabetic neuropathic pain in 2021 were completely treatment refractory and would benefit from new treatment options.
The acquired brands are well established and recognized among doctors and other members of the medical fraternity in Brazil for their reliability, safety, and trustworthiness
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
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
Paliperidone Extended-Release Tablets (RLD Invega) had estimated annual sales of US $112 million in the US
Availability of pharmaceutical-grade materials with broad API compatibility key to advancing drug delivery solutions
Mirabegron Extended-Release Tablets, 25 mg and 50 mg, had estimated annual sales of US $2.4 billion in US
Subscribe To Our Newsletter & Stay Updated
