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Results For "ANDA"

2604 News Found

Hyderabad startup’s Physiotherapy monitoring device ‘Pheezee’ receives USFDA
Medical Device | May 05, 2023

Hyderabad startup’s Physiotherapy monitoring device ‘Pheezee’ receives USFDA

Pheezee is designed to assess musculoskeletal and neuromuscular health.


Indoco receives EIR for its Plant I manufacturing facility in Goa
Drug Approval | May 04, 2023

Indoco receives EIR for its Plant I manufacturing facility in Goa

Indoco expects this change in compliance status to pave the way for approvals of ANDAs submitted from this site.


AstraZeneca Pharma India receives permission for sale and distribution of Trastuzumab deruxtecan
News | May 04, 2023

AstraZeneca Pharma India receives permission for sale and distribution of Trastuzumab deruxtecan

The receipt of this permission paves way for the launch of Trastuzumab deruxtecan (Enhertu) solution of 100mg/5mL in India


CHMP recommends EU approval of Roche’s fixed-duration Columvi for large B-cell lymphoma
Drug Approval | May 02, 2023

CHMP recommends EU approval of Roche’s fixed-duration Columvi for large B-cell lymphoma

Once approved, Columvi will be the first CD20xCD3 T-cell-engaging bispecific antibody available to treat people in Europe with this aggressive lymphoma


Biocon Biologics' new mAbs facility receives EU GMP Certification for bBevacizumab
News | April 29, 2023

Biocon Biologics' new mAbs facility receives EU GMP Certification for bBevacizumab

This approval reflects Biocon Biologics' compliance with the highest international regulatory standards


Evonik starts construction of new U.S. facility for pharmaceutical lipids
News | April 29, 2023

Evonik starts construction of new U.S. facility for pharmaceutical lipids

Cooperative agreement with U.S. Government to advance U.S. biopharma industry and ensure pandemic preparedness


Ipca Laboratories gets 3 observations for Piparia, Silvassa unit
Drug Approval | April 27, 2023

Ipca Laboratories gets 3 observations for Piparia, Silvassa unit

The company will submit its comprehensive response on these observations to the US FDA within the stipulated time


Xyall and Indica Labs forge collaboration to transform precision oncology workflows
News | April 25, 2023

Xyall and Indica Labs forge collaboration to transform precision oncology workflows

Bridging the gap between histopathology and molecular pathology


Zydus receives final approval from the USFDA for Metronidazole Topical Cream
Drug Approval | April 25, 2023

Zydus receives final approval from the USFDA for Metronidazole Topical Cream

Metronidazole is an antibiotic used on the skin to treat a certain skin disorder known as rosacea