Active Pharmaceutical Ingredient (API) Manufacturing in India

By: Tarun Agarwal

What is an Active Pharmaceutical Ingredient?
Commonly referred to as API, it’s a biologically active drug ingredient that makes the medications work. Simply put, APIs make medicines what they seem and not placebos. The U.S. Food and Drug Administration (USFDA) defines an API as any substance intended to be used in the manufacture of a drug product and that, when used in the production of a drug, becomes an active ingredient in the drug product.

API manufacturers in India
Aurobindo Pharma Ltd. is a leading Indian pharmaceutical company that delivers innovative solutions through cost-effective drug development and substantial marketing. Today, Aurobindo is one of the top API manufacturing companies in the world and one of the very few pharmaceutical companies that are vertically integrated with a presence in the API and Formulations segments.

Aurobindo’s state-of-the-art API manufacturing plants are backed by warehousing systems that offer ambient control room temperature and cold rooms. The API plants are equipped with dedicated quality control laboratories. Methodologies such as DIMAP, FEMA are practised as part of the company’s query management system. Aurobindo offers the complete bandwidth of products in penicillin, cephalosporin, Anti-retroviral, Anti-infective and more.

The manufacturing facilities have been accredited by several international regulatory bodies such as USFDA, UK’s MHRA (United Kingdom's Medicines and Health products Regulatory Agency), TGA Australia (Therapeutic Goods Administration), MCC South Africa (Medicines Control Council), ANVISA Brazil (National Health Surveillance Agency), Health Canada and GCC DR (Gulf Central Committee for Drug Registration).

Due to the presence of state-of-the-art manufacturing plants, quicker delivery and higher quality of products is assured. Aurobindo operates dedicated facilities for categories from intermediates to oral and sterile betalactams. Aurobindo API plants are equipped with particle size modifications systems to supply compacted materials.

Aurobindo’s expansion
Aurobindo is among the very few pharmaceutical companies present across betalactams and non-betalactams. In betalactams the company offers both sterile and non-sterile penicillin and cephalosporins along with penams. By maintaining cost leadership, the flexibility to switch manufacturing operations and, the competitiveness in various therapeutic domains, Aurobindo's API business has been in the top league, globally.

Aurobindo Pharma features among the top 10 companies in India in terms of consolidated revenues. The company has a very strong track record in the regulatory filings with 150 US DMFs (Drug Master Files) and over 2000 ANDA (Abbreviated New Drug Application) filings.

Aurobindo’s evolution into a key player in the pharmaceutical industry comes from various beneficial factors such as cost competitive manufacturing, operational excellence, diversified product portfolio and global leadership in anti-infective products.

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Tarun Agarwal is a blogger with a gold medal in Chemistry. He continues to write about the latest developments in the world of medicine. He also shares his thoughts on the same by applying his knowledge in creating or modifying formulae.

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