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Results For "ANDA"

2108 News Found

Carbogen Amcis (Shanghai) completed ANVISA Audit
Drug Approval | March 19, 2024

Carbogen Amcis (Shanghai) completed ANVISA Audit

A five-day inspection was concluded successfully with no critical and no major observations raised


Zydus receives USFDA approval for Finasteride and Tadalafil capsules
Drug Approval | March 18, 2024

Zydus receives USFDA approval for Finasteride and Tadalafil capsules

The drug will be manufactured at the group’s formulation manufacturing facility at Ahmedabad SEZ II, India


Evonik makes five generations healthier with EUDRAGIT coatings for targeted drug delivery
News | March 16, 2024

Evonik makes five generations healthier with EUDRAGIT coatings for targeted drug delivery

More than 10,000 scientific publications containing EUDRAGIT


Lupin receives Form 483 with 1 observation from USFDA after inspection at Aurangabad facility
Drug Approval | March 16, 2024

Lupin receives Form 483 with 1 observation from USFDA after inspection at Aurangabad facility

The company is confident of addressing the concern raised by the USFDA


Zydus receives USFDA final approval for chlorpromazine hydrochloride injection
Drug Approval | March 14, 2024

Zydus receives USFDA final approval for chlorpromazine hydrochloride injection

Chlorpromazine Hydrochloride Injection is used to treat certain mental/mood disorders


Venus Remedies gets huge global acclaim with UNICEF GMP approval
News | March 12, 2024

Venus Remedies gets huge global acclaim with UNICEF GMP approval

Venus Remedies' manufacturing unit, located in Baddi, Himachal Pradesh, has been recommended for supplying cephalosporin dry powder to UNICEF


AstraZeneca Pharma India, Mankind Pharma ink pact to distribute asthma medicine
News | March 12, 2024

AstraZeneca Pharma India, Mankind Pharma ink pact to distribute asthma medicine

India is contributing 13% to the global asthma burden and a disproportionate 43% of the global asthma deaths.


USFDA grants orphan drug and pediatric exclusivities for Cresemba for aspergillosis and mucormycosis in children
Drug Approval | March 12, 2024

USFDA grants orphan drug and pediatric exclusivities for Cresemba for aspergillosis and mucormycosis in children

CRESEMBA receives seven years and six months of US market exclusivity for these pediatric indications


Pfizer announces positive Phase 3 trial of ADCETRIS regimen in patients with DLBCL
Diagnostic Center | March 12, 2024

Pfizer announces positive Phase 3 trial of ADCETRIS regimen in patients with DLBCL

Pfizer to discuss regulatory submission with FDA, potentially leading to eighth indication for ADCETRIS