API’S

Overview

Aurobindo is one of the top API manufacturing companies in the world and also one of the very few pharmaceutical companies that are vertically integrated with a presence in the API and Formulations segments. This makes Aurobindo a truly unique and fully integrated global pharmaceutical company.By maintaining cost leadership and competitiveness in various therapeutic domains, Aurobindo’s API business has ensured the profitability and growth of the company’s Formulation business, in addition to becoming a top API supplier globally.We are one among the very few players present across beta lactams and non-beta lactams. In beta lactams we offer both sterile and non-sterile penicillin and cephalosporins along with penams. This was achieved by focusing on improving operational efficiencies with a careful and meticulous product selection strategy based on real time market requirements. By maintaining cost leadership, the flexibility to switch manufacturing operations and, the competitiveness in various therapeutic domains, Aurobindo’s API business is in the top league globally.

Development and Manufacturing

Our API business is supported by technologically advanced API research and development infrastructure, which develops new products and is engaged up to the delivery of products to the market.The API research division is housed in a sprawling 15-acre campus with a built up area of over five hundred thousand square feet which houses both chemical and analytical research along with a kilo lab. With experience of commercializing over 200 APIs, the research team is completely attuned to our growth aspirations. Committed to quality, safety and the environment, five of our manufacturing facilities have been inspected and approved by the US FDA, UK MHRA, TGA Australia, ANVISA and other trusted regulatory agencies.Our state-of-the-art manufacturing plants ensure that we deliver quality and scale. We have successfully integrated our capabilities and capacities to deliver a wide product portfolio that caters to the needs of diverse markets. Aurobindo operates dedicated facilities for categories from intermediates to oral and sterile beta lactams. There are multiple site filings to mitigate the supply risk and to ensure business continuity. Aurobindo API plants are equipped with particle size modifications systems to supply compacted and micronized materials.Manufacturing is backed by warehousing systems that offer ambient control room temperature (CRT) and cold rooms. API plants are equipped by site dedicated quality control laboratories. We practice DIMAP, FEMA methodologies as part of our QMS.We offer the complete bandwidth of products in Penicillin’s, Cephalosporin’s, Anti-retroviral, Anti-infective and other non-beta lactams. We also offer sterile and non-sterile anti-biotic.

Regulatory History

Aurobindo has a very strong track record in the regulatory filings. We have applied for 150 US DMFs and about 2000+ filings in other countries. Aurobindo has close to 500 patents in place.