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Milla Pharmaceuticals Inc. and the Alter Pharma Group Announce First Paragraph IV Filing and Acceptance by FDA

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...

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Milla Pharmaceuticals announces Third ANDA approval and the 4th U.S. approval for the Alter Pharma Group

Milla Pharmaceuticals Inc., 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. Pyridostigmine Bromide Syrup is indicated for symptomatic treatment of myasthenia gravis. Myasthenia gravis is a neuromuscular disorder primarily characterized by muscle weakness and...

Alter Pharma acquires EcoPharmaSupply
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Alter Pharma acquires EcoPharmaSupply

The Alter Pharma Group is proud to announce having acquired EcoPharmaSupply (EPS). 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...

Milla Pharmaceuticals Announces Approval of a Generic Version of Magnesium Sulfate in Water for Injection, in Non-PVC, Single-Patient Use Containers.
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Milla Pharmaceuticals Announces Approval of a Generic Version of Magnesium Sulfate in Water for Injection, in Non-PVC, Single-Patient Use Containers.

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 Magnesium Sulfate in Water for Injection, 2 g/50 mL (40 mg/mL), 4 g/100 mL (40 mg/mL), and 4 g/50 mL (80 mg/mL),...

Milla Pharmaceuticals Announces Approval and Launch of a Generic Version of Sodium Acetate Injection 2MEQ/mL by Pfizer Inc.
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Milla Pharmaceuticals Announces Approval and Launch of a Generic Version of Sodium Acetate Injection 2MEQ/mL by Pfizer Inc.

– Company granted 180-days of exclusivity under FDA Competitive Generic Therapy approval pathway – 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. Milla Pharmaceuticals was previously...