China-based Hotgen Biotech Co., Ltd (SHA: 688068) has announced receiving one certificate from the Saudi Food & Drug Authority (SFDA) and six certificates from the Drugs Controller General of India (DCGI) for its in-house developed products. These approvals mark significant milestones in the company’s global expansion efforts.
Saudi Arabia Approval
Specifically, Hotgen’s Coronavirus antigen test (colloidal gold method) was approved in Saudi Arabia for rapid in vitro and qualitative detection of the novel coronavirus antigen in human anterior nasal swabs. This test can be used for self-detection by non-professionals, highlighting its accessibility and ease of use.
Indian Approvals
In India, Hotgen secured certifications for the following products:
- C reactive protein/Serum amyloid A protein combo test (up-converting phosphor technology)
- Serum amyloid A protein (SAA) test (up-converting phosphor technology)
- Estradiol test (chemiluminescence immunoassay)
- Testosterone test (chemiluminescence immunoassay)
- Progesterone test (chemiluminescence immunoassay)
- Gastrin-17 test (chemiluminescence immunoassay)
These approvals underscore Hotgen’s commitment to providing a wide range of diagnostic solutions in the global market.
Future Outlook
The regulatory approvals from the SFDA and DCGI highlight Hotgen Biotech’s growing presence in key international markets. By expanding its product offerings and securing certifications, Hotgen aims to enhance its market position and provide innovative diagnostic solutions to healthcare providers and patients worldwide.-Fineline Info & Tech
