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 | MCC South Africa ANVISA Brazil | IDA | PIC/S | INVIMA Colombia | COFEPRIS Mexico | GCC DR MFDS – South Korea | MOH – Russia | DIGEMID – Peru
Annual Production Capacities
1.94 million gallons
36.878 million tonnes
45 billion units
6.7 billion units
20 million units
181 million units
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.