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Results For "483"

187 News Found

Briefs: Morepen Laboratories and Zydus Lifesciences
Drug Approval | March 27, 2023

Briefs: Morepen Laboratories and Zydus Lifesciences

The company is addressing these observations


Granules Consumer Health concludes FDA audit with zero observations
Drug Approval | March 22, 2023

Granules Consumer Health concludes FDA audit with zero observations

The audit is a pre-approval inspection for three products filed from the facility


Bliss GVS Pharma gets 3 minor observations from USFDA for Palghar unit
Drug Approval | March 19, 2023

Bliss GVS Pharma gets 3 minor observations from USFDA for Palghar unit

The observations are procedural in nature


Briefs: Man Industries, Jeevan Scientific Technology, Unichem and Torrent Pharmaceuticals
Drug Approval | March 18, 2023

Briefs: Man Industries, Jeevan Scientific Technology, Unichem and Torrent Pharmaceuticals

Man Industries (India) Limited has received a new export order of approximately Rs. 1,300 crores.


Keytruda + chemotherapy improved overall survival versus chemotherapy alone as for advanced malignant pleural mesothelioma
Clinical Trials | March 12, 2023

Keytruda + chemotherapy improved overall survival versus chemotherapy alone as for advanced malignant pleural mesothelioma

For the first-line treatment of patients with unresectable advanced or metastatic malignant pleural mesothelioma


Briefs: Alkem and Krsnaa Diagnostics
News | February 24, 2023

Briefs: Alkem and Krsnaa Diagnostics

Alkem has submitted a detailed corrective and preventive action (CAPA) plan to the regulator within the stipulated timelines.


Briefs: Neuland Laboratories, Cipla and Zydus
Drug Approval | February 20, 2023

Briefs: Neuland Laboratories, Cipla and Zydus

Cipla has received 8 inspectional observations in Form 483


Briefs: Biocon, Laurus Labs and Smruthi Organics
Drug Approval | February 13, 2023

Briefs: Biocon, Laurus Labs and Smruthi Organics

Laurus Labs has announced that the USFDA completed inspection of the formulations manufacturing facility Unit-2, APSEZ, Atchutapuram, Visakhapatnam, Andhra Pradesh.


USFDA inspection at Indoco Remedies's Solid Oral Formulation Facility at Goa
Drug Approval | January 24, 2023

USFDA inspection at Indoco Remedies's Solid Oral Formulation Facility at Goa

USFDA issued issued Form 483 with nine observations, which will be addressed within stipulated time.