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Results For "compliance"

519 News Found

Bajaj Healthcare announces receipt of EIR from USFDA
Drug Approval | September 14, 2023

Bajaj Healthcare announces receipt of EIR from USFDA

The company has received the Establishment Inspection Report (EIR) from the USFDA for the Pre-Approval Inspection (PAI) at a manufacturing site situated at Savli, Vadodara, Gujarat, with Zero 483 observations


AI to transform all processes in drug development by 2026, predicts CPHI Report
Digitisation | September 13, 2023

AI to transform all processes in drug development by 2026, predicts CPHI Report

In 2030 over 50% of FDA approvals will involve AI discovered and developed drugs


Caplin Steriles receives EIR from US FDA
Drug Approval | September 05, 2023

Caplin Steriles receives EIR from US FDA

The inspection classification was determined by the agency as Voluntary Action Indicated


Amgen settles with FTC over US$28 billion deal
Policy | September 04, 2023

Amgen settles with FTC over US$28 billion deal

Amgen will be prohibited from leveraging its drug portfolio to disadvantage rivals and will be required to seek prior approval before acquiring related products


Shilpa Medicare receives UK MHRA approval for mouth-dissolving strips to treat illnesses
News | September 03, 2023

Shilpa Medicare receives UK MHRA approval for mouth-dissolving strips to treat illnesses

This approval has come from the company's finished dosage form manufacturing facility


Briefs: Granules India
Drug Approval | August 28, 2023

Briefs: Granules India

Granules India received approval from Brazilian Health Regulatory Agency ANVISA


IBL Healthcare invests in KNISS Laboratories
Healthcare | August 28, 2023

IBL Healthcare invests in KNISS Laboratories

KNISS has established a solid foundation of trust in the customers' minds, delivering high quality Products uncompromisingly.


Glenmark Pharmaceuticals USA reaches antitrust settlement with DOJ
News | August 24, 2023

Glenmark Pharmaceuticals USA reaches antitrust settlement with DOJ

The company has entered into a three-year Deferred Prosecution Agreement


Briefs: Concord Biotech, Cian Healthcare and Eris Lifesciences
News | August 23, 2023

Briefs: Concord Biotech, Cian Healthcare and Eris Lifesciences

Eris Lifesciences enters into term loan agreement with Citi Bank