Aurobindo Pharma Limited, for the year ended March 31, 2007 has registered impressive financial performance.

Standalone

The formulation business significantly improved and now contributes to 29% of sales, grown multifold, reflecting the rapid momentum in the formulations business in regulated markets such as USA, EU. Now Aurobindo becomes a truly integrated global generic formulations company.

International business has risen to 64% of revenues. Aurobindo’s international marketing efforts in establishing its business in USA, EU and other key countries have helped achieve the landmark income and profits. 

US customers have supported Aurobindo’s launches and today Aurobindo’s products can be found in all channels of distribution. Aurobindo’s formulations are well accepted by the US pharmaceutical wholesalers and distributors and every major wholesaler or distributor is a client of Aurobindo. 

In Europe, Milpharm is cruising smoothly.  During the year, Aurobindo has acquired Pharmacin International B.V.; in Netherlands a profit making generic formulation company with over 200 approved marketing authorizations. This acquisition helps the company to further consolidate in the continent. Since the inception of Aurobindo Pharma (Pty) Ltd in South Africa in late 2005, and the subsequent filing of products to the South African Medicines Control Council, the company has been successful in obtaining 11 marketing authorizations in this brief period of 20 months. 

The leadership of Aurobindo in chemistry, technology and project execution in generic pharmaceutical industry which it attained over the years was consolidated further with several patents, DMFs / ANDAs and plant approvals by various agencies. 

Transformation of the company from an API selling organization in less regulated markets to a vertically integrated pharma company selling formulations all over the globe with emphasis in the markets of US & Europe took place very efficiently. Besides the company has achieved a balanced product mix with more CVS/CNS/ARV formulations being approved by acclaimed authorities like US FDA, UK MHRA etc.

During the year, 43 DMFs have been filed, taking the cumulative filings to 110 in the US/EU. This takes the filings in key markets to a cumulative figure of 503. This is a very significant leap and an acknowledged achievement in the pharmaceutical industry. 

During the year, 31 ANDAs were filed, taking the cumulative filings to 82. Overall, during the year, 98 filings have been done in key regulated markets including US and Europe taking the total cumulative filings in regulatory markets to 221.  Such a significant number of filings in a single year is a rare phenomenon in the pharmaceutical world. 

During the year, 13 ANDA approvals have taken place taking the cumulative approvals to 38 in USA..

During the year, Aurobindo has filed 15 CTD / DCP EU based dossiers and has received 3 approvals. Cumulatively the number of filings in EU stands at 35 with 5 approvals.  

During the year, Aurobindo filed 47 Dossiers in South Africa and the company had a head start with 9 approvals. Cumulatively, the no. of filings stands at 82 with 11 approvals. 

Similarly, aggressive filings and approvals are taking place in several key countries around the world. 

Most of the targeted infrastructure is approved by US FDA, UK MHRA, Health Canada, MCC (South Africa), Brazil (Anvisa), and other leading regulatory agencies (see Annexure I)

In Rs. Million

Aurobindo Pharma Limited, headquartered at Hyderabad, India, manufactures generic pharmaceuticals and active pharmaceutical ingredients.

The company has received approvals for most of the targeted API and formulation facilities from leading regulatory agencies like US FDA, UK MHRA, WHO, Health Canada, MCC South Africa.

The company’s robust product portfolio is spread over 6 major therapeutic/product areas encompassing Antibiotics, Anti-Retrovirals, CVS, CNS, Gastroenterologicals, and Anti-Allergics. 

The formulation portfolio is built on six technology platforms such as immediate release generics, SR/CR generics, and Orally disintegrating/Mouth dissolving generics, Combination products, Sterile/Lyophilized generics and Liquids/Dry syrups.

Aurobindo has filed over 110 DMFs and 90 ANDAs for the USA market alone in addition to filings in other countries. The pace of filings is matched by rapid product approvals from various markets. Till date Aurobindo received 45 ANDA approvals (both final and tentative) from US alone. Aurobindo operates in over 100 countries and markets over 180 APIs and 250 formulations.