Sun Pharma gets CDSCO panel nod for Teriparatide Injection
New Delhi: Pharmaceutical major, Sun Pharmaceuticals has got a go-ahead from the Subject Expert Committee (SEC) of the Central Drugs Standard Control Organization (CDSCO) for manufacturing and marketing of Teriparatide Injection, Solution for injection in a pre-filled pen 600mcg/2.4ml (Synthetic Origin). However, the permission comes with a couple of conditions, including that the firm should conduct a Phase IV Clinical Trial study.
This came after the drug maker, Sun Pharma presented its proposal for manufacturing and marketing of Teriparatide Injection, Solution for injection in a pre-filled pen 600mcg/2.4ml (Synthetic Origin) along with the bioequivalence (BE) study report and requested for clinical trial waiver before the committee.
Teriparatide is a recombinant parathyroid hormone used for the treatment of osteoporosis in men and postmenopausal women who are at high risk of having a fracture. It is also used to increase bone mass in men with primary or hypogonadal osteoporosis who are at high risk for fracture.
Recombinant teriparatide is marketed by Eli Lilly and Company under the brand name Forteo/Forsteo.
The CDSCO Committee thoroughly examined the proposal presented by Sun Pharmaceuticals for manufacturing and marketing of Teriparatide Injection, Solution for injection in a pre-filled pen 600mcg/2.4ml (Synthetic Origin) along with the bioequivalence (BE) study report and the request for clinical trial waiver, at 72nd SEC meeting for Analgesic & Rheumatology, held on 24.06.2021 & 25.06.2021 at CDSCO.
The committee noted that internationally, the product is already approved in countries such as the UK, Spain and France etc.
After detailed deliberation, responding to the proposal, the committee recommended grant of permission for manufacturing and marketing of Teriparatide Injection, Solution for injection in a pre-filled pen 600mcg/2.4ml (Synthetic Origin) subject to condition that the firm should conduct Phase IV CT study.
The committee also directed the firm that the protocol should be submitted to CDSCO within three months of approval. However, before final approval, CDSCO should ensure chemical and pharmaceutical comparability of the test and reference product along with testing the product in an IPC accredited lab in regard to quality.