Drug maker Aurobindo Pharma will set up a facility to manufacture 50 million dosages of vaccines per annum as it plans to launch its vaccine products commercially in 2018. Vaccines segment is another addition to the company’s differentiated portfolio where there are unmet needs and limited competition, Aurobindo Pharma said in its annual report. The company has formed a joint venture (JV) with the Hyderabad-based Tergene Biotech Private Limited, a vaccine development company, for developing pneumococcal conjugate vaccine (PCV). Tergene is currently working on development of the PCV.
PCV is a commercially available vaccine with limited competition and a global branded market of more than USD 6 billion, it said. “Aurobindo will hold a majority stake in the JV (with Targene Biotech) and will fund the product development in a phased manner spanning over three years. Development work for a few more products has commenced towards building a sizable vaccines portfolio. Toxicology studies have been completed.
“A cGMP pilot plant for clinical lot manufacture is ready and we are now working on clinical trial protocols. The plans are to create infrastructure for 50 million dosage per annum, with the first phase launch being targeted for 25 million doses. All these efforts are being synchronised to achieve commercial launch of Aurobindo’s branded products in 2018,” the company said in its annual report.
It, however, did not disclose information related to location of the manufacturing facility. The company is also in the process of developing a wide range of oncology and hormonal products which would include vials (wet vials and dry vials), prefilled syringes, capsules and tablets that are used in the hospital as well as in oncology and renal clinics, the report said.
“A new R&D centre dedicated for generic research in the field of oncology and hormones has been set up at Hyderabad to develop anticancer drugs and hormonal products, both for solid and parenteral dosage forms. The oral, solid dose formulations sections of oncology and hormone manufacturing facility has been completed and commissioned.
“The injectable areas of oncology facility are expected to be commissioned in later part of 2016. We have selected over 50 oncology products in our portfolio and plans are to initiate the exhibit batches for more than 15 products in 2016-17 and the dossier filing in regulated markets are expected to be initiated in early 2017,” Aurobindo said.
The drug maker also said a new block to manufacture oncology API is being added keeping the future requirements, and the facility is expected to be operational in 2017-18.
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