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Results For "Facility"

1627 News Found

SRL Diagnostics inaugurates an upgraded laboratory at Gurugram
Clinical Trials | November 03, 2022

SRL Diagnostics inaugurates an upgraded laboratory at Gurugram

The laboratory is equipped to perform high-volume diagnostic testing services


Alembic Pharma gets USFDA approval for Glycopyrrolate Injection USP
Drug Approval | November 01, 2022

Alembic Pharma gets USFDA approval for Glycopyrrolate Injection USP

This is the first injectable product approval from our General Sterile Facility (F-3) which was inspected in August, 2022.


Aptar Pharma completes Phase I global injectables expansion program
News | November 01, 2022

Aptar Pharma completes Phase I global injectables expansion program

The expansion program includes investments in France and the U.S., adding an additional 23,000+ m² of manufacturing footprint.


USFDA issues Form-483 for Lupin's Nagpur Unit-2
Drug Approval | October 31, 2022

USFDA issues Form-483 for Lupin's Nagpur Unit-2

The company is committed to addressing the observations at the earliest, and gaining approval for injectable manufacturing for the US


USFDA issues Form 483 for Parawada unit of Laurus Labs
Drug Approval | October 30, 2022

USFDA issues Form 483 for Parawada unit of Laurus Labs

The observation is procedural in nature and the company will address the observation within stipulated timelines.


Zydus gets USFDA’s approval for Ketorolac Tromethamine Tablets
Drug Approval | October 27, 2022

Zydus gets USFDA’s approval for Ketorolac Tromethamine Tablets

Ketorolac Tromethamine Tablets are indicated to relieve moderately severe pain, usually after surgery.


USFDA Issues a CRL for the Biologics License Application for Insulin Aspart
Drug Approval | October 27, 2022

USFDA Issues a CRL for the Biologics License Application for Insulin Aspart

The CRL did not identify any outstanding scientific issues with the product.


Zydus receives final approval from USFDA for Micafungin for Injection
Drug Approval | October 26, 2022

Zydus receives final approval from USFDA for Micafungin for Injection

Micafungin for Injection had annual sales of US $99 million in the United States according to IQVIA data


NHA join hands with NABH to expedite implementation of ABDM
Policy | October 19, 2022

NHA join hands with NABH to expedite implementation of ABDM

NABH shall encourage and provide assistance in onboarding their accredited/certified facilities on ABDM’s Health Facility Registry


Zydus receives tentative approval from USFDA for Roflumilast tablets
Drug Approval | October 18, 2022

Zydus receives tentative approval from USFDA for Roflumilast tablets

Roflumilast Tablets had annual sales of US $248 million in the United States according to IQVIA data