Sichuan Kelun Pharmaceutical Co., Ltd.
China's largest manufacturer of large-volume parenterals (IV infusion solutions) and specialty in…
China's largest manufacturer of large-volume parenterals (IV infusion solutions) and specialty injectable drugs. Operates a CDMO business alongside its branded IV fluids serving hospitals across China and in Southeast Asia and Africa.
- Type
- Manufacturer
- Location
- Leshan, China
- Founded
- 1996
- Website
- kelun.com
- Categories
- Medical & Healthcare Supplies
- Markets
- China, Vietnam, Thailand, Nigeria, Philippines
Verified facts
- corporate-mail-on-domain (green), checked 2026-08-06 Mail server of the company domain
- product-authorised-for-sale (green), checked 2026-08-20 NAFDAC Greenbook, Nigeria - register of authorised products (manufacturer named on the authorisation)
- domain-registered (green), checked 2026-08-06 Domain registry record
- lei-lapsed (amber), checked 2026-08-06 GLEIF
- sanctions-clear (green), checked 2026-08-06 OpenSanctions
- debarment-clear (green), checked 2026-08-06 OpenSanctions
Claimed certifications
- ISO 9001, Quality Management IAF CertSearch
- Good Manufacturing Practice
- ISO 14001, Environmental Management IAF CertSearch
Import rules for these goods
- Medical devices sold in the EU must carry CE marking under the Medical Device Regulation (EU) 2017/745, with a conformity assessment matched to the device risk class. European Commission (MDR)
- For the US market, the maker must have an FDA device establishment registration and product listing; most instruments also need 510(k) premarket clearance. US FDA (devices)