Ambio receives US-FDA approval for generic version of Forteo to treat osteoporosis

Ambio, Inc., an innovative biotech company developing novel peptide drugs, biosimilar, bioequivalent, and other complex generic drugs, announced that a generic version of Forteo (teriparatide injection) developed by Ambio and to be marketed and sold by Apotex has been approved by the US Food and Drug Administration (FDA).

“Ambio is a world leader in developing complex peptides. Our highly skilled techniques in controlling various kinds of peptide-related synthetic impurities together with expertise in developing advanced analytical methods to thoroughly characterize the peptides sets us apart in the pharmaceutical industry,” said Simrat Singh, president of Ambio, Inc. “We are thrilled that the teriparatide injection developed by Ambio has received FDA approval.”

“The approval further validates our expertise and technological innovation as a developer and manufacturer of complex generic drugs and supports our commitment to bring high quality and affordable therapies to patients,” said Chris Bai, founder, chairman of the board, and chief executive officer of Ambio, Inc. “We are pleased to partner with Apotex in this effort which allowed them to expeditiously secure FDA approval and immediately execute product launch.”

“The launch of Teriparatide Injection reflects Apotex’s continued focus on improving access for patients to affordable complex generic drugs,” said Kiran Krishnan, SVP of global regulatory affairs at Apotex. “We are pleased to deliver this critical product, in partnership with Ambio, that we believe will be essential in improving the quality of life for Osteoporosis patients in the US.”

Teriparatide injection 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.

Ambio is an innovative biotech company developing novel peptide drugs, biosimilar, bioequivalent, and other complex generic drugs, with unmatched expertise and technological advances in synthetic peptide drug development.

Apotex Corp. is a US based company, headquartered in Weston, Florida. It and its global affiliates are leaders in generic pharmaceuticals and biosimilars and are committed to supplying patients with a broad portfolio of high-quality, affordable medicines covering all major therapeutic areas.

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