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Results For "approval"

2608 News Found

Thermo Fisher receives AIFA’s GMP approval for manufacturing facility of RNA-based products in Italy
News | January 22, 2024

Thermo Fisher receives AIFA’s GMP approval for manufacturing facility of RNA-based products in Italy

GMP certification helps enable biotechnology customers to accelerate accessibility of new RNA-based therapies for patients


Shilpa Medicare receives Europe approval for Amifampridine Tablets, 10 mg
Drug Approval | January 20, 2024

Shilpa Medicare receives Europe approval for Amifampridine Tablets, 10 mg

This product has sales of about US$ 20 million in Europe


Lupin receives USFDA’s approval for Febuxostat Tablets
Drug Approval | January 19, 2024

Lupin receives USFDA’s approval for Febuxostat Tablets

Febuxostat Tablets (RLD Uloric) had estimated annual sales of US$ 27 million in the U.S. (IQVIA MAT November 2023)


Zydus receives USFDA’s approvals for Pimavanserin Capsules, 34 mg and Pimavanserin Tablets,10 mg
Drug Approval | January 18, 2024

Zydus receives USFDA’s approvals for Pimavanserin Capsules, 34 mg and Pimavanserin Tablets,10 mg

Pimavanserin is an atypical antipsychotic indicated for the treatment of hallucinations and delusions associated with Parkinson disease psychosis


Unichem receives ANDA approval for Doxazosin Tablets
Drug Approval | January 11, 2024

Unichem receives ANDA approval for Doxazosin Tablets

Doxazosin tablets are indicated for the treatment of hypertension, to lower blood pressure


Lupin receives tentative approval from USFDA for Dapagliflozin and Saxagliptin tablets
Drug Approval | January 04, 2024

Lupin receives tentative approval from USFDA for Dapagliflozin and Saxagliptin tablets

Dapagliflozin and Saxagliptin Tablets (RLD Qtern) had estimated annual sales of US $5 million in the US


Alembic Pharmaceuticals received 8 USFDA approvals in Q3FY24
Drug Approval | January 03, 2024

Alembic Pharmaceuticals received 8 USFDA approvals in Q3FY24

The company has received five final approvals


Venus Remedies secures marketing approval from Israel, Colombia for two oncology drugs
News | December 30, 2023

Venus Remedies secures marketing approval from Israel, Colombia for two oncology drugs

The company has received marketing authorisation for docetaxel from Israel and cytarabine from Colombia


Lupin receives USFDA approval for Loteprednol Etabonate Ophthalmic Suspension, 0.2%
Drug Approval | December 27, 2023

Lupin receives USFDA approval for Loteprednol Etabonate Ophthalmic Suspension, 0.2%

Loteprednol Etabonate Ophthalmic Suspension, 0.2%, is indicated for the temporary relief of the signs and symptoms of seasonal allergic conjunctivitis