Register entry
- Registered sites
- 4
- Active NDC listings
- 1
- Live patents
- 0
- Countries
- 3
- Base
- Germany
Authorisation
Registered operations
Analytical testing1Active ingredient (API) manufacture4Finished drug manufacture1
Sites
Registered establishments
4| Establishment | Address | Registered for | FEI / DUNS |
|---|---|---|---|
| Wacker Biotech GmbH | Heinrich-Damerow-Strasse 4, Halle/Salle, Saxony-Anhalt 06120, Germany (DEU) | Active ingredient (API) manufacture | 3008840280313408357 |
| Wacker Biotech GmbH | Hans-Kn�ll-Strasse 3, Jena, Thuringia 07745, Germany (DEU) | Active ingredient (API) manufacture | 3005503554329804632 |
| Wacker Biotech B.V. | Paasheuvelweg 30, Amsterdam, 1105 BJ, Netherlands (NLD) | Analytical testing, Active ingredient (API) manufacture, Finished drug manufacture | 3008539577404171600 |
| Wacker Biotech US, Inc.Registrant: Wacker Biotech GmbH | 10390 Pacific Center Court, San Diego, California (CA) 92121, United States (USA) | Active ingredient (API) manufacture | 3020427414060255223 |
Catalogue
Marketed products
1| Brand | Generic name | Form / route | NDC |
|---|---|---|---|
| - | RETEPLASE | solution | 72820-100BULK INGREDIENT |
Neighbours
Registered in the same town
12- PCI Pharma Services Canada, Inc.San Diego, CA · 3 sites
- Nielsen BioSciences, Inc.San Diego, CA · 2 sites
- PETNET Solutions, Inc.San Diego, CA
- Synergy Health AST, LLCSan Diego, CA
- STA Pharmaceutical US LLCSan Diego, CA
- Infinity Labs, SD Inc.San Diego, CA
- SOHM, Inc.San Diego, CA
- Verio Healthcare, Inc.San Diego, CA
- Allermed Laboratories, Inc.San Diego, CA
- CA-BOTANA INTERNATIONALSAN DIEGO, CA
- EVER Pharma Jena GmbHJena, DEU
- King Tech Industry, Inc.San Diego, CA
Compare
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- Merz Pharma GmbH & Co. KGaA3 sites · 17 NDC
- Bavarian Nordic A/S3 sites · 10 NDC
- Aesica Pharmaceuticals S.r.l.3 sites · 2 NDC
- BioNTech Manufacturing GmbH3 sites · 0 NDC
- Nuvisan France SARL3 sites · 0 NDC
- Octapharma Pharmazeutika Produktionsgesellschaft m.b.H.5 sites · 0 NDC
Enquiry
Common questions
- Is Wacker Biotech GmbH FDA approved?
- Wacker Biotech GmbH holds 4 FDA-registered establishments across 3 countries. Registration puts a site on the FDA's register and open to inspection; it is not an approval of the company. Approvals attach to individual drug applications.
- Where are Wacker Biotech GmbH's drugs manufactured?
- At registered sites in Germany, the Netherlands, the United States. The FDA register lists Halle/Salle; Jena; Amsterdam; San Diego, CA. Registered operations: analytical testing, active ingredient (API) manufacture, finished drug manufacture.
- What drugs does Wacker Biotech GmbH make?
- 1 product is listed under Wacker Biotech GmbH in the openFDA NDC Directory, most often as solution. The full breakdown by dosage form and route is above. A listing count is not a sales figure.
Compiled from FDA establishment registrations, the openFDA NDC Directory, the Orange Book and the FDA drug shortage database. Not claimed by the company. Sources and methodology.