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Results For "ANDA"

3110 News Found

Alembic Pharmaceuticals receives USFDA final approval for Lamotrigine Extended-Release Tablets
Drug Approval | October 03, 2024

Alembic Pharmaceuticals receives USFDA final approval for Lamotrigine Extended-Release Tablets

Lamotrigine extended-release tablets are indicated for adjunctive therapy for primary generalized tonic-clonic seizures and partial-onset seizures


Clariant to launch eight new high-performing excipients at the CPHI Milan 2024
News | October 03, 2024

Clariant to launch eight new high-performing excipients at the CPHI Milan 2024

Clariant is launching high-performing pharmaceutical ingredients to support the evolution of safe and effective medicines


Aurobindo Pharma receives USFDA approval for Cephalexin Tablets
Drug Approval | October 02, 2024

Aurobindo Pharma receives USFDA approval for Cephalexin Tablets

The product is expected to be launched in Q3FY25


SMS Pharma receives EDQM certification to supply Ibuprofen in Europe
Drug Approval | October 02, 2024

SMS Pharma receives EDQM certification to supply Ibuprofen in Europe

The inspection conducted by EDQM at its Visakhapatnam facility


Zydus receives tentative approval from USFDA for Enzalutamide Tablets
Drug Approval | October 02, 2024

Zydus receives tentative approval from USFDA for Enzalutamide Tablets

Enzalutamide Tablets will be produced at the Group’s manufacturing site at SEZ, Ahmedabad


Apitoria Pharma gets Form 483 with 10 observations from USFDA
Drug Approval | October 01, 2024

Apitoria Pharma gets Form 483 with 10 observations from USFDA

The observations are of procedural in nature and will be responded to within the stipulated time


Krsnaa Diagnostics and Medikabazaar to invest Rs. 300+ crore to set up imaging centers
News | October 01, 2024

Krsnaa Diagnostics and Medikabazaar to invest Rs. 300+ crore to set up imaging centers

The special financing terms offered by United Imaging and structured by Medikabazaar to Krsnaa Diagnostics underscore the strategic importance of this alliance


USFDA completes inspection at Biocon Biologics’ Insulins facility at Malaysia
Drug Approval | September 30, 2024

USFDA completes inspection at Biocon Biologics’ Insulins facility at Malaysia

The inspection concluded with the issuance of a form 483 with five observations


AbbVie submits Biologics license application to USFDA for Telisotuzumab Vedotin
Drug Approval | September 28, 2024

AbbVie submits Biologics license application to USFDA for Telisotuzumab Vedotin

Teliso-V is an investigational antibody-drug conjugate (ADC) for patients with previously treated nonsquamous non-small cell lung cancer (NSCLC) with c-Met protein overexpression


Zydus receives USFDA final approval for Enzalutamide Capsules, 40 mg
Drug Approval | September 28, 2024

Zydus receives USFDA final approval for Enzalutamide Capsules, 40 mg

Enzalutamide Capsules will be produced at the Group’s manufacturing site at Moraiya, Ahmedabad