Ambio, Inc., a pioneering biotechnology company specializing in the development of innovative peptide drugs, biosimilars, bioequivalents, and other intricate generic drugs, announced today that the U.S. Food and Drug Administration (FDA) has granted approval for a generic version of Forteo®1 (teriparatide injection) developed by Ambio. This generic product will be marketed and sold by Apotex.

Simrat Singh, President of Ambio, Inc., highlighted the company's global leadership in complex peptide development, emphasizing their advanced techniques for controlling peptide-related synthetic impurities and expertise in creating sophisticated analytical methods for peptide characterization. Singh expressed excitement about the FDA approval for the teriparatide injection developed by Ambio.

Chris Bai, Founder, Chairman of the Board, and CEO of Ambio, Inc., underscored the approval as a validation of Ambio's expertise and technological innovation in developing and manufacturing complex generic drugs. Bai also expressed pleasure in the partnership with Apotex, facilitating swift FDA approval and immediate product launch.

Kiran Krishnan, SVP of Global Regulatory Affairs at Apotex, emphasized the company's commitment to enhancing patient access to affordable complex generic drugs. Krishnan stated that the launch of Teriparatide Injection aligns with Apotex's focus on delivering critical products in collaboration with Ambio to improve the quality of life for osteoporosis patients in the U.S.

Teriparatide Injection, the approved generic product, is available in a single-patient-use pre-filled pen containing 250 mcg/mL, capable of administering 28 daily doses of 20 mcg per pen. Stakeholders are encouraged to refer to the complete prescribing information and Medication Guide for comprehensive details on Warnings and Precautions, Adverse Reactions, and Contraindications.

 

Source: businesswire.com

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