Hybio Pharmaceutical is an API manufacturer based in China. It holds 25 active US drug master files and 5 valid CEPs across a filed portfolio of 23 molecules. Its filings concentrate with US FDA, AEMPS (ES) and JFDA (JO). Its GMP standing is certified by ANVISA (Brazil), US FDA and EMA. Its most recent recorded inspection, by US FDA, closed on 5 December 2025 as NAI.
NAI means no action indicated, VAI means voluntary action indicated, and OAI means official action indicated.
| Site | FDA FEI |
|---|---|
| SHENZHEN, China | Not on file |
| Pingshan, China | Not on file |
| China, China | 3026377169 |
| China, China | 3011090684 |
| Molecule | Regulators | Docs |
|---|---|---|
| Semaglutide | US FDA | 3 |
| Degarelix | US FDA | 2 |
| Desmopressin | EDQM, US FDA | 2 |
| Ganirelix | SFDA (Saudi Arabia), US FDA | 2 |
| Linaclotide | US FDA | 2 |
| Liraglutide | US FDA | 2 |
| Oxytocin | EDQM, US FDA | 2 |
| Teriparatide | US FDA | 2 |
| Abaloparatide | US FDA | 1 |
| Atosiban | SFDA (Saudi Arabia) | 1 |
| Cannabidiol | US FDA | 1 |
| Cetrorelix | US FDA | 1 |
| Difelikefalin | US FDA | 1 |
| Eptifibatide | US FDA | 1 |
| Etelcalcetide | US FDA | 1 |
| Glatiramer | US FDA | 1 |
| Nesiritide | US FDA | 1 |
| Octreotide | EDQM | 1 |
| Plecanatide | US FDA | 1 |
| Retatrutide | US FDA | 1 |
| Somatostatin | EDQM | 1 |
| Terlipressin | EDQM | 1 |
| Tirzepatide | US FDA | 1 |
Also appears on these molecule pages
| Regulator | Filings | GMP certificates |
|---|---|---|
| US FDA | 2 | 1 |
| AEMPS (ES) | 2 | None |
| JFDA (JO) | 1 | None |
| ANVISA (Brazil) | None | 1 |
| EMA | None | 1 |
Answered from this company's own record. Where a register holds nothing, the question is not asked rather than answered with a zero. How we count our figures.
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