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Results For "USFDA"

1134 News Found

Granules India Q3 FY25 PAT drops 6% to Rs 118 Cr
News | January 27, 2025

Granules India Q3 FY25 PAT drops 6% to Rs 118 Cr

The company said it voluntarily paused production at the Gagillapur plant in September 2024 for risk assessment on account of the USFDA observations


Dr Reddy’s Labs Q3 FY25 profit up 2% YoY at Rs. 1,413 Cr
News | January 23, 2025

Dr Reddy’s Labs Q3 FY25 profit up 2% YoY at Rs. 1,413 Cr

The revenue from operations in Q3 FY25 is Rs. 8,358.6 crore, up 16% YoY


Briefs: Cipla and IOL Chemicals and Pharmaceuticals
News | January 21, 2025

Briefs: Cipla and IOL Chemicals and Pharmaceuticals

Mesalazine is used to treat inflammatory bowel disease


Glenmark Life Sciences rebranded as Alivus Life Sciences
News | January 19, 2025

Glenmark Life Sciences rebranded as Alivus Life Sciences

The change is reflective of the company’s evolving vision aimed at further strengthening its global presence and a commitment to providing innovative solutions in the API and CDMO space


Datroway approved in the US for patients with previously treated metastatic HR-positive breast cancer
Drug Approval | January 18, 2025

Datroway approved in the US for patients with previously treated metastatic HR-positive breast cancer

Datroway is the eighth new medicine of the 20 AstraZeneca has set out to deliver by 2030


FDA issues five observations to Jubilant Pharmova’s Salisbury facility in USA
Drug Approval | January 17, 2025

FDA issues five observations to Jubilant Pharmova’s Salisbury facility in USA

Jubilant Cadista will submit an appropriate action plan to the USFDA on these observations


Bayer’s pharma growth strategy progressing well as pipeline advances
News | January 15, 2025

Bayer’s pharma growth strategy progressing well as pipeline advances

Regulatory filings underway for a third indication for darolutamide in prostate cancer, for finerenone in a common form of heart failure, and acoramidis in transthyretin amyloid


Senores receives ANDA approval for marketing Metoprolol Tartrate and Hydrochlorothiazide Tablet USP
Drug Approval | January 13, 2025

Senores receives ANDA approval for marketing Metoprolol Tartrate and Hydrochlorothiazide Tablet USP

Metoprolol Tartrate and Hydrochlorothiazide Tablet is the combination tablet of metoprolol tartrate, a beta adrenoceptor blocker and hydrochlorothiazide (HCTZ), a thiazide diuretic, indicated for the treatment of hypertension, to lower blood pressure


Biocon Biologics embarks on a three-stage strategic journey
News | January 08, 2025

Biocon Biologics embarks on a three-stage strategic journey

Successfully transformed the organization from a two-country operation focused on development and manufacturing to a fully integrated company with a strong commercial engine bringing us closer to patients in over 120 countries


Zydus inks agreement with CVS Caremark to add Zituvio, Zituvimet and Zituvimet XR to its template formulary
News | January 07, 2025

Zydus inks agreement with CVS Caremark to add Zituvio, Zituvimet and Zituvimet XR to its template formulary

These three NDAs of Sitagliptin (base) and combination franchise have been approved by the USFDA earlier through the 505(b)(2) route