MINNETONKA, Minn.--(BUSINESS WIRE)--Milla Pharmaceuticals Inc., a subsidiary of the Alter Pharma Group, announced that it has received FDA approval for its generic version of Precedex®, Dexmedetomidine Hydrochloride Injection 4mcg/ml in 50mL and 100mL, and plans to launch in the very near future.
Milla Pharmaceuticals Inc. and the Alter Pharma Group Announce Launch of a Generic Version of Magnesium Sulfate in Water for Injection, in Non-PVC, Single-Patient Use Containers by Their Partner Athenex Pharmaceutical Division (APD)
MINNETONKA, Minn.--(BUSINESS WIRE)--Milla Pharmaceuticals Inc., a subsidiary of the Alter Pharma Group, announced it has filed its ANDA Application with Paragraph IV Certification on July 20th, 2022 and received a Paragraph IV Acknowledgement Letter and Receipt from FDA on August 31st, 2022. After providing the requisite notice to the NDA holder, the Company reports that the NDA holder has not commenced legal action against the Company within the statutory time frame. It is also worth noting the product is currently listed on FDA’s Drug Shortages List.
MINNETONKA, Minn.--(BUSINESS WIRE)--Milla Pharmaceuticals Inc., a subsidiary of the Alter Pharma Group, announces U.S. Food and Drug Administration (FDA) has granted approval to the Company's Abbreviated New Drug Application (ANDA) for a generic version of Mestinon® (Pyridostigmine Bromide Syrup) 60 mg/5mL.
ANDERLECHT, Belgium--(BUSINESS WIRE)--EPS is a Belgian pharmaceutical services and products company, distributor and partner of choice for several pharmaceutical brands on the Benelux market including prescription drugs, medical devices, OTC pharmaceuticals and consumer health products. The investment will allow Alter Pharma to enhance its services and product offering further leveraging its regulatory compliance and market know-how while leaning on its extensive procurement and logistics network.
MINNETONKA, Minn.--(BUSINESS WIRE)--Milla Pharmaceuticals, a subsidiary of the Alter Pharma Group, announced that it has received abbreviated new drug application (ANDA) approval from the U.S. Food and Drug Administration (FDA) for its generic version of Sodium Acetate Injection 2MEQ/mL.
Liège, Belgium – 24 June 2021 – Hyloris Pharmaceuticals SA (Euronext Brussels: HYL), a specialty biopharma company committed to bringing innovative treatments that offer added value to underserved patient populations, today announces that it has successfully renegotiated and unwound its earlier license agreements with the Alter Pharma Group. Hyloris will pay the Alter Pharma Group a total lump sum of €5.25 million plus €0.5 million potential earn-out, thereby waiving any further future financial obligations towards the Alter Pharma Group.
Luye Pharma Group recently signed two agreements with partners in Latin America, boosting further development of the central nervous system (CNS) drugs Seroquel® (quetiapine fumarate, immediate release, IR) and Seroquel XR® (extended release formulation) in the local markets.