FDA approves Ambio’s generic version of Forteo developed in collaboration with Apotex

Ambio, Inc., a leader in biotech innovation specializing in peptide drugs and complex generics, has announced that its generic version of Forteo (teriparatide injection), developed in collaboration with Apotex, has received approval from the U.S. Food and Drug Administration (FDA).

Ambio’s Technological Prowess in Peptide Development

Simrat Singh, President of Ambio, Inc., highlighted the company’s world-class capabilities in developing complex peptides. Ambio’s expertise in controlling peptide-related synthetic impurities and advanced analytical methods sets a high standard in the pharmaceutical industry. The FDA approval of the teriparatide injection underscores Ambio’s leading role in the sector.

Collaboration and Commitment to Affordable Therapies

Chris Bai, Founder, Chairman of the Board, and Chief Executive Officer of Ambio, Inc., emphasized the approval as a testament to the company’s expertise and technological innovation. The partnership with Apotex facilitated the swift FDA approval and product launch, aligning with Ambio’s commitment to providing high-quality and affordable therapies.

Apotex’s Dedication to Accessible Healthcare

Kiran Krishnan, SVP of Global Regulatory Affairs at Apotex, reiterated the company’s focus on improving access to affordable complex generic drugs. This collaboration with Ambio aims to enhance the quality of life for osteoporosis patients in the US.

Teriparatide Injection: An Essential Treatment for Osteoporosis

The newly approved Teriparatide Injection, designed for osteoporosis treatment, is supplied as a single-patient-use pre-filled pen containing 250 mcg/mL, capable of administering 28 daily doses of 20 mcg per pen. This development marks a significant milestone in the treatment options available for osteoporosis patients.