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Results For "GMP"

394 News Found

USFDA completes inspection at Aurolife Pharma’s Raleigh unit
Drug Approval | August 29, 2022

USFDA completes inspection at Aurolife Pharma’s Raleigh unit

The unit has filed 2 Derma products and 1 MDI product.


ProBioGen enters into master service agreement with NextPoint Therapeutics
News | August 18, 2022

ProBioGen enters into master service agreement with NextPoint Therapeutics

The integrated services ensure that NextPoint can bring their molecule to the clinic in a timely manner.


PIB: Quality control of Ayush drugs
Policy | August 03, 2022

PIB: Quality control of Ayush drugs


Casper Pharma completed USFDA pre-approval inspection
Drug Approval | July 31, 2022

Casper Pharma completed USFDA pre-approval inspection

The audit is part of the agency's inspection for three product applications filed and slated to be manufactured at this site.


SMS Pharmaceuticals receives approval for Ibuprofen by EDQM
Drug Approval | July 24, 2022

SMS Pharmaceuticals receives approval for Ibuprofen by EDQM

With this, the company can start selling Ibuprofen in the European markets.


W.R. Grace to expand capacity at small-molecule API plant
News | July 13, 2022

W.R. Grace to expand capacity at small-molecule API plant

The expansion at CDMO facility in South Haven, will bring a new 4,000-gallon multi-use reactor train consisting of glass lined and stainless-steel materials of construction


US FDA Inspection at Alkem's Indore manufacturing facility
Drug Approval | July 08, 2022

US FDA Inspection at Alkem's Indore manufacturing facility

This GMP and Pre-Approval Inspection is part of the routine business operations and the company shall submit to US FDA within the stipulated timeline


Wacker to expand mRNA-based actives capacity at Halle, Germany
News | July 06, 2022

Wacker to expand mRNA-based actives capacity at Halle, Germany

Company is investing more than €100 million in the expansion of the Halle site


Microsize launched as Independent pharma services company
News | July 04, 2022

Microsize launched as Independent pharma services company

Meets the growing need for US-based API solubility and bioavailability enhancement services


Biosynth Carbosynth expands peptide offering with acquisition of Pepscan
News | July 01, 2022

Biosynth Carbosynth expands peptide offering with acquisition of Pepscan

Addition of Pepscan with its peptide discovery, lead optimization and GMP manufacturing capabilities provides end-to-end offering to Biosynth Carbosynth’s peptide customers.