Companies
LePure Biotech
Chinese firms like LePure Biotech are aggressively reverse-engineering and scaling domestic production of single-use bags and tubing to break the historical duopoly of US and German suppliers.
- Country
- China
Commercial
China Supply
Coverage
| CN | EU | US | |
|---|---|---|---|
| consumables | ✓ | ✓ | ✓ |
Regulatorsfdaema
Verifiable facts
| Fact | Value | Source |
|---|---|---|
| Funding | Completed Series C financing round of hundreds of millions of RMB led by Novo Holdings, General Atlantic, and Goldman Sachs Asset Management in January 2023 | vcbeathealth.com |
| Capacity | Annual production capacity includes 1.2 million sets of single-use process bags, 2,500 sets of bioprocess equipment, 300 tons of culture media, and 3 million bottles of clean products across various facilities | lepurebiotech.com.cn · lepure-bio.com |
| Certification | ISO 9001 and ISO 13485 certified quality management systems | lepurebiotech.com |
| Certification | Validation services accredited under ISO 17025 and CNAS | lepurebiotech.com |
| Regulatory approval | Completed FDA Drug Master File (DMF) filings for single-use bag product lines including LeKrius, LeRybow, and LeRugia | lepurebiotech.com |
| Production site | Manufacturing bases located in Shanghai (Songjiang, Lingang), Suzhou, Zhongshan, and Zhejiang | lepurebiotech.com.cn · lepurebiotech.com |
Independent sources: lepure-bio.com · vcbeathealth.com
Technologies
| Name | Cluster | Risk | |
|---|---|---|---|
| Single-use assemblies | consumables | Low | → |
Compiled by BIOECON from primary sources.
Compliance
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