| As a major diversification,
the company is setting up a state of the modern
art multi product and multi utility Bio-tech
and Bio-pharma facility of International
Standards to develop, manufacture and market
strategically selected injectables, bio-parenterals
including Oncology Products. Construction
of this unit is under progress at the S.P.Biotechnology
Park situated at Turkapally, Shameerpet, Hyderabad.
This plant shall utilize cell fusion
techniques, hybridomas recombinant DNA technology,
protein engineering and structure based molecular
design which are part of modern Biotechnology.
The product range shall include Biosimilar
products, such as Erythropoietin, G-CSF, Interferon
Alpha, Interferon Beta, Human Growth Hormone
and Recombinant Human Insulin.
The company’s proposed manufacturing
facilities will produce sterile injectables.
The facilities proposed to be set up will
be as per cGMP standards and strictly
adhere to European, Australian and US FDA
standards to cater and catch the
opportunity of contract manufacturing for
leading Biopharma MNCs arising as a result
of WTO agreements after 2005
and also growing global generic markets.
On site chemical and microbiological
analytical laboratories as well as ultra
modern packing and warehousing facilities
are being created. The company is adapting
global standard operating procedures and
systems, attract and retain qualified personnel
so as to enable it to meet the latest cGMP
and US FDA requirements and guidelines.
As specialists in the manufacture of Biosimilars,
Biologicals, Therapeutic Proteins, Monoclonal
Antibody the company proposes to
offer the following full service solutions
for our contract manufacturing customers.
- Bioprocessing /purification of active
materials
- Scale up
- Formulation development
- Validation
- Packing design
- QC/QA testing
- Regulatory affairs
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