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Results For "USFDA"

1205 News Found

Aurobindo Pharma receives USFDA approval for Fingolimod Capsules, 0.5 mg
Drug Approval | March 02, 2024

Aurobindo Pharma receives USFDA approval for Fingolimod Capsules, 0.5 mg

The product will be launched in March 2024


Piramal Pharma gets Form 483 with 2 observations from USFDA for Lexington, USA facility
Drug Approval | February 26, 2024

Piramal Pharma gets Form 483 with 2 observations from USFDA for Lexington, USA facility

The observations do not pose any risk to site's compliance standards or its business continuity


Orchid Pharma's 'Exblifep' receives USFDA approval
Drug Approval | February 24, 2024

Orchid Pharma's 'Exblifep' receives USFDA approval

Orchid is the first company from India, ever to have invented a product which has received a New Drug Approval (NDA) from USFDA


Lupin receives approval from USFDA for Minzoya
Drug Approval | February 17, 2024

Lupin receives approval from USFDA for Minzoya

Minzoya Tablets are indicated for use by females of reproductive potential to prevent pregnancy


Zydus receives USFDA approval for Isosorbide Mononitrate Extended-Release, Tablets USP
Drug Approval | February 17, 2024

Zydus receives USFDA approval for Isosorbide Mononitrate Extended-Release, Tablets USP

Isosorbide mononitrate is used to prevent chest pain (angina) in patients with a certain heart condition (coronary artery disease)


Aparna Group forays into pharma business; Receives USFDA clearance for manufacturing unit
News | February 15, 2024

Aparna Group forays into pharma business; Receives USFDA clearance for manufacturing unit

The company is strongly committed to enhancing customer satisfaction and catering to the discerning needs of renowned pharmaceutical companies


Zydus receives Tentative Approval from the USFDA for Dexamethasone Tablets USP, 1 mg
Drug Approval | February 10, 2024

Zydus receives Tentative Approval from the USFDA for Dexamethasone Tablets USP, 1 mg

Dexamethasone is used to treat conditions such as arthritis, blood/hormone disorders, allergic reactions


Zydus receives USFDA’s final approval for Gabapentin Tablets, 300 mg and 600 mg
Drug Approval | January 26, 2024

Zydus receives USFDA’s final approval for Gabapentin Tablets, 300 mg and 600 mg

Gabapentin is indicated for the management of Postherpetic Neuraligia


Strides receives USFDA approval for Pregabalin Capsules
Drug Approval | January 26, 2024

Strides receives USFDA approval for Pregabalin Capsules

The Pregabalin capsules has a market size of ~US$248 mn per IQVIA