Drug Approval | December 23, 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
Formulation revenue decreased by 7.6% YoY to Rs. 4,770 crore whereas in Q2 FY23, API business posted a growth of 24.2% YoY with revenue of Rs. 969.4 crore
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's long-term strategy is on science, technology and innovation and the company's strategy relating to this is on track
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
Sildenafil for Oral Suspension (RLD Revatio) had estimated annual sales of US $64 million in the US
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