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First new chemical entity discovered by Indian scientists gets USFDA approval

First new chemical entity discovered by Indian scientists gets USFDA approval
Rhizen has retained commercialisation rights for India while also being the manufacturing and supply partner for Umbralisib. Alembic owns 50 per cent stake in Rhizen
PB Jayakumar | February 9, 2021 | Updated 12:10 IST
Umbralisib receives USFDA approval
Umbralisib, a novel cancer drug discovered and out-licensed by India s Alembic Pharmaceuticals and its associate drug discovery company Rhizen Pharmaceuticals, has received the drug regulatory approval for sales in the US market. The drug is touted to be the first new chemical entity (NCE) discovered by Indian scientists to secure a US Food and Drug Administration (FDA) approval. ....

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Cadila Healthcare Ltd Q3FY21 consolidated net profit higher at Rs. 527.2. crore

Cadila Healthcare Ltd Q3FY21 consolidated net profit higher at Rs. 527.2. crore
Posted On:
CADILA HEALTHCARE LTD. has reported financial results for the period ended December 31, 2020.
Financial Results (Q3 FY20-21) - QoQ Comparison
The company has reported total income of Rs.3823.1 crores during the period ended December 31, 2020 as compared to Rs.3847.5 crores during the period ended September 30, 2020.
The company has posted net profit / (loss) of Rs.527.2 crores for the period ended December 31, 2020 as against net profit / (loss) of Rs.473.4 crores for the period ended September 30, 2020.
The company has reported EPS of Rs.5.15 for the period ended December 31, 2020 as compared to Rs.4.62 for the period ended September 30, 2020. ....

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USFDA Grants Orphan Drug Designation To Zydus Cadila s Saroglitazar Mg

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USFDA Grants Orphan Drug Designation To Zydus Cadila s Saroglitazar Mg
The United States Food and Drug Administration (USFDA) has granted ODD to Saroglitazar Mg, Cadila Healthcare said in a regulatory filing.
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Zydus Cadila on Thursday said the US health regulator has granted orphan drug designation (ODD) to its Saroglitazar Mg used for the treatment of patients with Primary Biliary Cholangitis (PBC), a liver disease.
The United States Food and Drug Administration (USFDA) has granted ODD to Saroglitazar Mg, Cadila Healthcare said in a regulatory filing.
Zydus Cadila, which is a part of Cadila Group, said orphan drug designation provides eligibility for certain development incentives, including tax credits for qualified clinical testing, prescription drug user fee exemptions and seven-year marketing exclusivity upon USFDA approval. ....

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Zydus granted Orphan Drug Designation by the USFDA for Saroglitazar in the treatment of patients with Primary Biliary Cholangitis (PBC)

Zydus granted Orphan Drug Designation by the USFDA for Saroglitazar in the treatment of patients with Primary Biliary Cholangitis (PBC) ....

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Zydus Group: USFDA grants orphan drug designation to Zydus Cadila's Saroglitazar Mg

Synopsis
Zydus Cadila, which is a part of Cadila Group, said orphan drug designation provides eligibility for certain development incentives, including tax credits for qualified clinical testing, prescription drug user fee exemptions and seven-year marketing exclusivity upon USFDA approval.
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New Delhi: Zydus Cadila on Thursday said the US health regulator has granted orphan drug designation (ODD) to its Saroglitazar Mg used for the treatment of patients with Primary Biliary Cholangitis (PBC), a liver disease. The United States Food and Drug Administration (USFDA) has granted ODD to Saroglitazar Mg,
Cadila Healthcare said in a regulatory filing.
Zydus Cadila, which is a part of Cadila Group, said orphan drug designation provides eligibility for certain development incentives, including tax credits for qualified clinical testing, prescription drug user fee exemptions and seven-year marketing exclusivity upon USFDA appr ....

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