Teriparatide

Teriparatide comprises of the biologically active N-terminal portion of the parathyroid hormone. Parathyroid hormone (PTH), parathormone or parathyrin, is secreted by the chief cells of the parathyroid glands and acts to increase the concentration of calcium in the blood by acting upon the parathyroid hormone receptor. Teriparatide is used in the treatment of osteoporosis to reduce the incidence of fractures. USV’s recombinant PTH has been developed using non-infringing cloning, fermentation and purification technology. PCT applications have been filed.

Status:

Pre-clinical toxicity studies have been successfully completed as per schedule Y of Drugs & Cosmetics Act, India
Confirmatory safety & efficacy clinical trial (Phase-III) in India completed successfully
Marketing Authorisation in India obtained from DCGI for Teriparatide injection, both drug substance & drug product (vials)
Manufacturing license obtained from State FDA for both Drug substance & drug product (vials)
Received WHO-GMP certification (India) for Teriparatide concentrated solution (bulk drug)
Collaborations in few geographies
Dossier available for BRIC, MENA, CIS & ASEAN countries

Indications:

For the treatment of postmenopausal women with osteoporosis who are at a high risk of fracture. It increases Bone Mineral Density (BMD) and reduces the risk of vertebral and non-vertebral fractures.

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