Drug Approval | January 10, 2023
Fesoterodine Fumarate Extended-Release Tablets, 4 mg and 8 mg, (RLD Toviaz®) had estimated annual sales of USD 177 million in the U.S. (IQVIA MAT September 2022).
The estimated national burden of asthma in India is at 17.23 million with an overall prevalence of 2.05% and out of this, approximately 30 lakh patients can be classified under “inadequately controlled”
The expansion in Indore is well-aligned with Lupin Diagnostics’ commitment to improving access to high-quality, reliable, and advanced testing centres and home collection facilities at an affordable price
Diclofenac Sodium Topical Solution, 2% w/w (RLD PENNSAID) had estimated annual sales of US $509 million in the US (IQVIA MAT October 2022)
Spiro will be responsible for the overall strategy, implementation and growth of Lupin’s U.S. Generics business
Natco Chlorantraniliprole (CTPR) Process does not infringe FMC's Indian Patent 298645.
The joint venture will help both the parties to further develop the high-margin service business
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
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