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Results For "manufacturing-facility"

648 News Found

Zydus receives final approval from the USFDA for Bisoprolol Fumarate Tablets
Drug Approval | July 26, 2022

Zydus receives final approval from the USFDA for Bisoprolol Fumarate Tablets

Bisoprolol Fumarate Tablets are used to treat high blood pressure.


Zydus receives final approval from the USFDA for Efinaconazole Topical Solution
Drug Approval | July 18, 2022

Zydus receives final approval from the USFDA for Efinaconazole Topical Solution

Jublia (Efinaconazole) topical solution, 10% had annual sales of $292 million in the United States according to IQVIA data (IQVIA MAT May 2022).


Dr. Reddy's Laboratories updates on PAI of formulations facility
Drug Approval | July 08, 2022

Dr. Reddy's Laboratories updates on PAI of formulations facility

The company has been issued a Form 483 with two observations which the company will address within the stipulated timeline.


Lupin’s Somerset manufacturing plant Receives EIR from US FDA
Drug Approval | July 08, 2022

Lupin’s Somerset manufacturing plant Receives EIR from US FDA

The US FDA has determined that the inspection classification of the facility is Voluntary Action Indicated


Biocon Biologics receives EU GMP Certification for its in Bengaluru
News | July 06, 2022

Biocon Biologics receives EU GMP Certification for its in Bengaluru

This integrated, multi-product facility houses manufacturing suites, analytical testing laboratories and warehousing.


Zydus receives final approval from USFDA for Lacosamide injection
Drug Approval | July 01, 2022

Zydus receives final approval from USFDA for Lacosamide injection

Lacosamide Injection is used to treat partial-onset seizures.


HIL to commercialise VCRC Bti bio-larvicide technology for mosquito vector control programs
News | June 28, 2022

HIL to commercialise VCRC Bti bio-larvicide technology for mosquito vector control programs

HIL has set up the Bti bio-larvicide manufacturing facility at its Rasayani Plant at Maharashtra with the financial assistance of GEF/UNIDO under the project


Glenmark Pharmaceuticals to address USFDA’s observation
News | June 23, 2022

Glenmark Pharmaceuticals to address USFDA’s observation

U.S. FDA has issued Form 483 with six observations after an inspection of the company’s formulation manufacturing facility based out of Baddi


Briefs: Marksans Pharma and Alkem
News | June 22, 2022

Briefs: Marksans Pharma and Alkem

The US FDA had conducted an inspection of Alkem Laboratories Limited's manufacturing facility located at St. Louis, USA.


Medix Biochemica acquires Bioresource Technology
News | June 21, 2022

Medix Biochemica acquires Bioresource Technology

Bioresource Technology's state of the art manufacturing facility in Weston, Florida