Aurobindo launches separate contract manufacturing services division AuroSource

Aurobindo Pharma Limited, one of the leading suppliers of APIs in India, has launched a contract manufacturing services division AuroSource to cater global pharma and biotech companies.

AuroSource will function as a service oriented and customer-centric division within the company providing custom R&D and manufacturing (CRAMS) services for large, mid-sized and emerging biotech and pharmaceutical entities globally, Aurobindo said in a press release.

AuroSource will partner with companies to research, manufacture and develop compounds across the entire drug life cycle.

AuroSource will offer customized manufacturing solutions for active pharmaceutical ingredients (APIs), intermediates, pre-formulations and formulations across each stage of the pharmaceutical life cycle.

The company will also provide support services on regulatory as well as research and development (R&D)  from the pre-clinical stage through the post patent expiry phase in drug development.

Solutions for product life cycle management including life cycle extensions and line extensions will also come under the ambit of AuroSource’s services, the statement said.

“We [AuroSource] stand to become an invaluable partner in enabling them to streamline and simplify their development and manufacturing processes so they can focus primarily on creating life-saving, low-cost products and contribute to making global healthcare more affordable,” said Ramprasad Reddy, chairman of Aurobindo Pharma Ltd.

Large pharmaceutical manufacturers are reducing their capabilities and consolidating their outsourcing needs for pharmaceutical intermediates and formulated API’s (Active Pharmaceutical Ingredients). The growth of consolidated trust-worthy suppliers creates an untapped market for contract manufacturing services, the press statement noted.

The AuroSource team culled from the parent company has the expertise of commercialising more than 200 APIs and 120 finished drug products.

Dr R Ananth will be president of AuroSource.

Aurobindo, is one of India’s largest pharmaceutical companies with more than U.S. $800 million in annual sales.

Aurobindo has 15 manufacturing facilities for both API and finished dosage – including 10 approved by the U.S. Food & Drug Administration.

Aurobindo now has a total of 113 ANDA approvals (84 Final approvals and 29 Tentative approvals) from USFDA.
Aurobindo Pharma’s product portfolio is spread over 6 major therapeutic/product areas encompassing antibiotics, anti-retrovirals, CVS, CNS, gastroenterologicals, and anti-allergics.

Aurobindo Pharma has alliances with original research companies in the area of custom synthesis.

Aurobindo Pharma offers a comprehensive custom synthesis services in organic custom synthesis and chemical development. All the six manufacturing plants of the company conform to international standards, with a variety of reactors – more than 300 SS, glass lined, high pressure and sterile reactors, spray drier, and hydrogenators. All are cGMP compliant.

Under the organic custom synthesis module, Aurobindo offers a full range of services to meet the varying needs by utilizing established synthetic routes, modifying customer processes, designing novel routes with complete chemical, chromatographic, spectroscopic back up for starting materials, intermediates, reference compounds, metabolites, resolution of enantiomers, structural isomers etc.

As part of the chemical development service, Aurobindo offers scale-up of existing processes, preparation of intermediates in milligrams to kilo lots, processes optimization, development and use of purification techniques and alternate process routes.

The company also has R&D capabilities spread across five facilities specializing in process chemistry development, dosage form development and pre-formulations.

AuroSource is setting up a modern R&D facility at Pashamylaram. AuroSource has also drwn up plans to start offering services in fields such as medicinal chemistry and other discovery services.

Aurobindo Pharma posted net profit of Rs 128.29 crore in Q2 September 2009 as against a net loss of Rs 38.50 crore in the same quarter last year.

Aurobindo Pharma’s net sales rose 30% to Rs 826.31 crore in Q2 September 2009 over Q2 September 2008.