Hetero has over 36 advanced manufacturing facilities strategically located across the world – including India, USA, China, Russia, Egypt, Mexico and Indonesia. Approved by stringent global regulatory authorities, Hetero facilities have integrated quality systems and processes to ensure adherence to cGMP (current Good Manufacturing practices). They are also vertically integrated and can be utilised for large-scale production of APIs, formulations in various dosage forms rapidly.
We make continuous investments in upgradation of manufacturing facilities with special emphasis on deploying advanced machinery and adopting latest technologies to comply with 21 CFR. Besides enabling us consistently produce high quality medicines at an affordable cost, it also helps us in passing through regulatory audits with relative ease. It is these advantages that make us the partner of choice for major global pharmaceutical companies.
The approvals from various global Ministries of Health and Regulatory authorities include :
US FDA | EU GMP | TGA Australia | PMDA Japan | MHRA UK | SAHPRA | ANVISA BRAZIL | INVIMA COLOMBIA | COFEPRIS MEXICO | GCC DR | MFDS SOUTH KOREA | MOH RUSSIA | PIC/S
Annual Production Capacities
1.94 million gallons
36.878 million tonnes
54 billion units
7 billion units
23 million units
181 million units
(*includes lyophilized, liquids and powder)
Biosimilars Bulk drugs
135 per annum
Biosimilars Formulation Manufacturing
0.75 billion units per annum
0.60 billion units per annum
Our Manufacturing Facilities
Hetero Chemical Complex is Asia’s largest manufacturing SEZ Complex for APIs which houses more than 1000 reactors and is spread over 500 acres near Visakhapatnam, India.