FDA’s NME approvals declined substantially in 2022, causing overall New Drug Application (NDA) approvals to drop
New GMP facility for clinical and small-scale commercial pharmaceutical lipids
APF Futurity is made from polyolefin materials with no metal parts or recycling disruptors
BDRs journey for the treatment of Prostate Cancer started with Abiratarone Acetate, then Leuprolide Acetate followed by Enzalutamide and, then Degarelix and Triptorelin.
The expansion program includes investments in France and the U.S., adding an additional 23,000+ m² of manufacturing footprint.
Both the partners will work towards bringing Aster Pharmacy’s in-house quality care products to serve the healthcare needs of the local population in KSA
The inspection concluded with no observation (FDA-483) issued.
The companies will leverage their respective proprietary technology platforms
Aster Pharmacy will be operated by GD Assist Limited in Bangladesh.
The audit is part of the agency's inspection for three product applications filed and slated to be manufactured at this site.
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