News | June 17, 2023
USFDA completes inspection at Dr Reddy's Laboratories' Bollaram API unit
The inspection closed with zero observations
The inspection closed with zero observations
The company will submit its comprehensive response on these observations to the US FDA
Granules now has a total of 58 ANDA approvals from US FDA
Total investments could reach €70 million, of which approximately 15% in R&D and 85% in capex, that would be deployed from 2026
Diclofenac Sodium and Misoprostol Delayed Release Tablets USP, 50mg/200 mcg and 75mg/200 mcg had annual sales of USD 13 mn in the United States
Metoprolol Succinate ER Tablets are indicated for the treatment of hypertension in order to lower blood pressure.
The application is in line with Innocan's strategy to expand the scope of its combined magnesium and cannabis topical solution
UTD2 is the world's first oral epothilone microtubule inhibitor
Ministry of Health, Labour and Welfare to evaluate zolbetuximab as treatment option for patients with advanced gastric and gastroesophageal cancers
Application being reviewed under the FDA Project Orbis framework, which enables concurrent reviews among US, Australia, Canada, Switzerland, Singapore and United Kingdom health authorities
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