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Home » Topics » Drugs » GMPs

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EU GMP Report — May 2023

May 18, 2023
This monthly feature consists of excerpts from articles printed in GMP Newsletter LOGFILE, reprinted by permission of the publisher, GMP-Verlag Peither AG. Read More

USP and Phlow Partner to Validate Continuous Manufacturing Processes

December 15, 2022
Under the terms of the agreement, the methods that will come out of this partnership will be made available to other domestic generics manufacturers. Read More

FDA Classifies Glenmark Inspection as Official Action Indicated

October 28, 2022
Glenmark said it will engage with the FDA to resolve the deficiencies observed during the inspection. Read More

Takeda to Spend $300 Million to Expand Biotech Manufacturing Site

September 15, 2022
The investment is the largest to date for Takeda in Belgium. Read More

Orca Bio to Build Facility to Manufacture 3,000 Cell Therapy Products Annually

September 9, 2022
The new plant is expected to be operational in the first half of 2023. Read More

Aurobindo’s CuraTeQ to Expand Manufacturing Operations via New $37M Facility

September 8, 2022
The new site is likely to be up and running by 2026. Read More

Bavarian Nordic to Outsource Its Vaccine Supply

August 19, 2022
To stretch the available doses, the FDA issued an emergency authorization that allows for a one-fifth dose to be administered beneath the top layer of the skin. Read More

Pfizer-BioNTech to Deliver Omicron-Adapted Vaccines in October

August 9, 2022
A bivalent vaccine has not yet been approved by the FDA. Read More

FDA Greenlights Jynneos Monkeypox Vaccine for Additional Manufacturing

July 29, 2022
U.S. distribution is expected to begin shortly. Read More

Pfizer to Spend $470 Million in Expansion of Vaccine Research Facilities

July 25, 2022
The facility will continue research into the messenger RNA technology that underpins the Pfizer-BioNTech COVID-19 vaccine. Read More

Bavarian Nordic’s Danish Manufacturing Plant FDA-Inspected for Jynneos Monkeypox Vaccines

July 15, 2022
The U.S. has a limited supply of the Jynneos vaccine. Read More

FDA Review of Santhera’s Vamorolone NDA Delayed Due to Manufacturing Standards

July 5, 2022
The FDA has granted vamorolone Orphan Drug status, as well as Fast Track and Rare Pediatric Disease designations. Read More
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