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Results For "ANDA"

2121 News Found

Shilpa Pharma Lifesciences’ Unit 2 Raichur has cleared the ANVISA-Brazil GMP inspection
News | July 10, 2024

Shilpa Pharma Lifesciences’ Unit 2 Raichur has cleared the ANVISA-Brazil GMP inspection

The Unit has been issued GMP Certification from ANVISA-Brazil


Zydus receives final approval from USFDA for Sacubitril and Valsartan Tablets
Drug Approval | July 10, 2024

Zydus receives final approval from USFDA for Sacubitril and Valsartan Tablets

Sacubitril and Valsartan combination is used to treat chronic heart failure in adults


Biostar Pharma gets FDA clearance of the IND application for a Phase 2 study of Utidelone Injection
Drug Approval | July 09, 2024

Biostar Pharma gets FDA clearance of the IND application for a Phase 2 study of Utidelone Injection

Utidelone can penetrate BBB due to its unique physicochemical characteristics and insusceptibility to P-glycoprotein-mediated efflux


Aster Health Academy announces strategic partnerships with premier Hospitals across India
News | July 08, 2024

Aster Health Academy announces strategic partnerships with premier Hospitals across India

The academy has secured partnerships with 15 esteemed hospitals


GSK and CureVac restructure collaboration into new licensing agreement
News | July 05, 2024

GSK and CureVac restructure collaboration into new licensing agreement

CureVac receives €400 million upfront and up to an additional €1.05 billion in development, regulatory and sales milestone payments as well as tiered royalties; all previous financial considerations from the prior collaboration agreement replaced


Briefs: Alembic Pharmaceuticals  and Relonchem
Drug Approval | July 05, 2024

Briefs: Alembic Pharmaceuticals and Relonchem

Alembic Pharmaceuticals receives 11 USFDA product approval during Q1 FY2025


Urgent need to redefine pharma companies’ role on several issues of the industry: Dr. K. Nagaiah, Chief Scientist, CSIR - IICT, Hyderabad
Opinion | July 04, 2024

Urgent need to redefine pharma companies’ role on several issues of the industry: Dr. K. Nagaiah, Chief Scientist, CSIR - IICT, Hyderabad

The expiry date of almost all strips is rubber stamped vanish in a matter of 3 to 4 months, making the remaining tablets waste for subsequent use before expire date


Sipavibart EMA regulatory submission accepted under accelerated assessment for COVID-19 prevention
Drug Approval | July 03, 2024

Sipavibart EMA regulatory submission accepted under accelerated assessment for COVID-19 prevention

Submission based on positive SUPERNOVA Phase III trial data which demonstrated a statistically significant reduction in the incidence of COVID?19 in an immunocompromised patient population


Alembic Pharmaceuticals announces USFDA final approval for Doxycycline Capsules, 40 mg
Drug Approval | June 29, 2024

Alembic Pharmaceuticals announces USFDA final approval for Doxycycline Capsules, 40 mg

Doxycycline capsules are indicated for the treatment of only inflammatory lesions (papules and pustules) of rosacea in adult patients