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Results For "ANDA"

2123 News Found

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


India releases revised operational guidelines of non-alcoholic fatty liver disease
Policy | September 28, 2024

India releases revised operational guidelines of non-alcoholic fatty liver disease

India has taken the lead in recognising NAFLD as a major non-communicable disease


India reaffirms commitment to social determinants of health at UNGA
Policy | September 28, 2024

India reaffirms commitment to social determinants of health at UNGA

India called for stronger investments in health and social equity at G20 Joint Finance-Health Task Force Meeting


Torrent Pharmaceuticals refutes claims of Shelcal 500 allegedly failing CDSCO quality test
News | September 27, 2024

Torrent Pharmaceuticals refutes claims of Shelcal 500 allegedly failing CDSCO quality test

The sample seized by CDSCO is not manufactured by Torrent and is in fact non-genuine and spurious


India highlights need for global cooperation to address AMR threat at UNGA
Policy | September 27, 2024

India highlights need for global cooperation to address AMR threat at UNGA

AMR poses a critical threat to global public health undermining decades of progress made in the field of modern medicine


Zydus and CSIR-CDRI Lucknow to develop drug for CKD induced Osteoporosis
News | September 27, 2024

Zydus and CSIR-CDRI Lucknow to develop drug for CKD induced Osteoporosis

Studies suggest that the protein Sclerostin plays a key role in the dysregulation of bone metabolism


Alembic receives USFDA final approval for Paliperidone ER tablets
News | September 27, 2024

Alembic receives USFDA final approval for Paliperidone ER tablets

Paliperidone extended-release tablets are an atypical antipsychotic agent indicated for treatment of schizophrenia


Vaishali Pharma plans M&A route to drive growth
News | September 25, 2024

Vaishali Pharma plans M&A route to drive growth

Focus on consolidation could help them strengthen their position in the competitive pharmaceutical industry, potentially driving expansion and improving efficiencies