As a leader in the global pharmaceutical industry, Hetero demonstrates its capabilities across a number of strengths including quality, capacity, portfolio and special capabilities. For over two decades, Hetero has built its reputation and success on excellence in each of these areas:
Hetero is proficient in achieving regulatory approvals worldwide of both APIs and formulations. With an integrated quality system to ensure adherence to cGMP practices, Hetero is committed to quality and its manufacturing facilities are approved by global regulatory agencies. In addition, Hetero continues to invest in its state-of-the-art manufacturing facilities and capabilities to ensure that it is able to provide the highest level of quality standards in the pharmaceutical industry.
With over 18 manufacturing facilities across the globe, including five plants in Special Economic Zones, Hetero can manufacture over 40 billion oral doses annually. Hetero offers the largest campus of API reactor capacity in the world. In the US, Hetero operates two oral solid dose formulation facilities with multi-billion unit capacities. In addition, Hetero produces 40% of the world's supply of anti-retroviral drugs.
Hetero's portfolio includes US drug master files for over 300 APIs, and over 150 US ANDAs have been filed. Additionally, the company has obtained approvals for marketing drugs globally in a wide range of therapeutic categories.
Hetero's wide range of capabilities includes finished dosage forms (sterile, pre-filled syringe, tablet, capsule, liquid oral dosage, ointments, soft gels, and inhalers), US DEA Schedule II drugs, and biosimilar monoclonal antibody products. Also, with strong manufacturing development in both API's and finished dosages, Hetero is a leader in specialized therapeutic areas (including oncology and anti-retroviral drugs).