Aurobindo Pharma, one of the largest manufacturers of APIs from Asia withover 100 APIs exported to over 100 countries is emerging as a verticallyintegrated, global pharma company and is poised for a rapid growth.
It has manufacturing facilities based in USA, China, Brazil,subsidiaries based in Europe, Asia, Africa and Latin America. The company has nine state-of-the-art. It has fifty API manufacturing blocks, fifteen formulation modules, manufacturing sterile and non-sterile APIs and dosage formulations.
The company is striving to emerge as a significant player in the US and EU markets by building IPR based product portfolio in APIs and formulations during 2004-05 and is to continue its thrust in semi synthetic penicillins (SSPs), cephalosporins (Cephs), anti-HIVs, anti-fungals, antibiotics, central nervous system (CNS) and Cardio Vascular System (CVS) drugs in all emerging markets.
Its generics programme for the regulated markets is gaining momentum. Currently, the company has 5 Drug Master Files (DMF) and 2 Abbreviated New Drug Applications (ANDA) pending before the US FDA. This number is likely to increase with 10-15 submissions expected over the current financial year.
Additionally, 5 applications for Certificates of Suitability (CoS) and 10 applications for EDMF have been filed with the EDQM. It has recently received the first CoS.
Its subsidiaries include APL Pharma Thai Ltd (Thailand), Aurobindo HK Ltd (Hongkong), AB Farmo Quiica Ltd (Brazil), APL Holdings Inc (USA), Aurobindo (Datong) Bio-Pharma Co. Ltd.(China), Aurobindo Tongling (Datong) Pharmaceuticals Co. Ltd. (China), Helix Healthcare BV (The Netherlands), APL Chemi Natura Ltd (India). Its joint ventures include Aurosol Pharma LLC (USA), Cephazone Pharma Inc (USA), Citadel Aurobindo Biotech Ltd (India).
A new formulations research centre set up at Mumbai will speed up research for potential generic opportunities. It is believed to steer operational initiatives and unleash its R & D potential.
The world market for generic drugs is growing by about 11 per cent a year. In the US, prescriptions of generic drugs account for around 42 per cent of all prescriptions. The US, Japan and Germany account for approximately 60 per cent of the world generics market. Drugs sold under the name of the active substance are so successful that in the US market the average cost to the user represents a saving of atleast 30 per cent over that of branded drugs.
Post 2005, over $ 50 billion worth of branded revenue will be thrown open to generic competition. In readiness for highly competitive markets, it has reverse integrated its pipeline to include APIs, intermediates and formulations. Aurobindo has identified and standardized non-infringing processes that go toward the making of select antibiotics, antidepressants and hypertension drugs. The company may be in a position to register a number of potentially lucrative patents by fiscal 2005.
Its bio-equivalence facility is equipped with sophisticated laboratory testing equipment to verify that its generics equal the existing branded products in all aspects. Aurobindo seeks to produce and market affordable bio-equivalent formulations.
The company has invested over Rs. 487 crore to scale up its production capabilities during the past three years to ensure it has the capacity to meet the present and future demand for its products. Aurobindo has concentrated its R & D efforts on diversifying its product portfolio. Several drugs facing patent expiry have been identified as low-risk high return opportunities. It believes to be present in its recognized areas of competence with a wide basket backed up with requisite international regulatory approvals.
The company has upgraded its business model and is focusing its energies towards the regulatory as well as the global generics market. It aims to emerge as a global pharma company with a visible presence in the markets of the First World.