Pune (Maharashtra) [India], August 20 (ANI/PRNewswire): Enzene Biosciences Ltd. "Enzene" announces a successful Marketing Authorization (MA) from the Drug Controller General of India (DCGI) for its second biosimilar drug "Romiplostim", indicated for the treatment of chronic Immune Thrombocytopenic Purpura (ITP) in adults.
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Enzene Biosciences Ltd. obtains marketing authorization for its first biosimilar molecule in India ANI | Updated: Feb 04, 2021 12:49 IST
Pune (Maharashtra) [India], February 4 (ANI/PRNewswire): Recently Enzene Biosciences Ltd. announced that it has obtained Marketing Authorisation (MA) from Drug Controller General of India (DCGI) for Teriparatide - bioactive part of human parathyroid hormone (PTH), an anabolic approach to the treatment of Osteoporosis, compared to the anti-resorptive therapies such as bisphosphates and SERMs.
According to company sources the clinical trial conducted for Enzene s Teriparatide is one of the most comprehensive trial for teriparatide in India which includes PK (Pharmacokinetics), Immunogenicity as well as efficacy arm. The company sources also revealed that the approved product will be marketed through their holding company Alkem Laboratories Ltd. and is also exploring other potential partnering opportunities.