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Results For "USFDA"

1130 News Found

Zydus announces Phase IV EVIDENCES-XI trial to generate Real World Evidence of Saroglitazar Mg in NAFLD patients with comorbidities
Diagnostic Center | June 10, 2023

Zydus announces Phase IV EVIDENCES-XI trial to generate Real World Evidence of Saroglitazar Mg in NAFLD patients with comorbidities

The primary endpoint is to measure the change in liver stiffness measurement performed by transient elastography from Baseline to Week 52


Briefs: Ipca Laboratories, Lupin and Zydus
News | June 05, 2023

Briefs: Ipca Laboratories, Lupin and Zydus

The company has extended its full co-operation and support to the officials of the Income Tax Department


Briefs: Dr. Reddy's Laboratories and Max Healthcare Institute
News | May 15, 2023

Briefs: Dr. Reddy's Laboratories and Max Healthcare Institute

Dr. Reddy's Laboratories has been issued a Form 483 with four observations


Cigniti bags ‘Best IoT Healthcare Platform’ award in 2023
News | May 10, 2023

Cigniti bags ‘Best IoT Healthcare Platform’ award in 2023

The Awards recognizes standout digital health & medical technology products and companies


Briefs: Dr. Reddy's Laboratories
News | May 06, 2023

Briefs: Dr. Reddy's Laboratories

USFDA has issued Form 483 with one observation


Strides and Orbicular enter into a strategic partnership to develop a range of nasal sprays
News | May 04, 2023

Strides and Orbicular enter into a strategic partnership to develop a range of nasal sprays

The partnership will commercialize four nasal sprays with a combined Global IQVIA market size in excess of $400m


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.


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