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 is the eighth new medicine of the 20 AstraZeneca has set out to deliver by 2030
Jubilant Cadista will submit an appropriate action plan to the USFDA on these observations
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
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
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
These three NDAs of Sitagliptin (base) and combination franchise have been approved by the USFDA earlier through the 505(b)(2) route
The inspection, which is a routine part of the FDA's regulatory oversight, evaluates compliance with Good Manufacturing Practices and other regulatory requirements.
India's bio economy has experienced remarkable growth, skyrocketing from $10 billion in 2014 to over $130 billion in 2024, with projections to reach $300 billion by 2030
FDC Ltd has received final approval from USFDA for the company's Abbreviated New Drug Application (ANDA) for Cefixime 400 mg Tablets
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