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Natco Pharma received a Form 483 with seven observations from the USFDA after an inspection in Hyderabad. Conducted from June ...
Capricor Therapeutics (CAPR) announced the completion of the Food and Drug Administration’s pre-license inspection of its San Diego manufacturing facility for Deramiocel, the company’s lead cell ...
Capricor Therapeutics' rating was downgraded amid FDA inspection risks, regulatory uncertainty, and potential delays in approval for deramiocel. Read more on CAPR stock here.
"The U.S. Food and Drug Administration (FDA) had conducted an inspection at our Pharma Division located in Kothur, Hyderabad, ...
Hyderabad: Gland Pharma, a generic injectable & ophthalmic focused pharmaceutical company, has announced that the Company has ...
Sun Pharma said the US FDA issued a Form-483 with eight observations after inspecting its Halol facility from June 2–13.
NATCO Pharma said that the U.S. Food and Drug Administration (FDA) had conducted an inspection at the API manufacturing plant located in Mekaguda, Hyderabad, India, which was conducted from 09 to 13 ...
On Friday, BTIG reaffirmed its Buy rating and $10.00 stock price target for Humacyte (NASDAQ:HUMA) following the release of a Form 483 from the FDA.
HYDERABAD: Pharma major Dr Reddy’s Laboratories on Saturday said its active pharmaceutical ingredients manufacturing facility at Middleburgh in New York has been issued a Form 483 with two ...
Sun Pharma announced that the USFDA issued a Form 483 with eight observations after inspecting its Halol manufacturing plant ...
In the 2024 Form 483s, the FDA deemed certain of the company’s ... Integra Lifesciences Implements New Severance Program for ExecutivesIntegra LifeSciences assumed with an Underweight at ...
USFDA issued a Form 483 with seven observations to Natco Pharma's Hyderabad facility after an inspection. Natco Pharma is ...