Register entry
EMD Serono, Inc.
- Registered sites
- 12
- Drug products
- 18
- Live patents
- 11
- Countries
- 7
- Base
- France
Authorisation
Registered operations
What the FDA has registered these sites to do. This is the regulatory record, not a marketing claim.
Analytical testingActive ingredient (API) manufactureLabellingFinished drug manufacturePackagingsterilize
Sites
Facilities
12| Site | Location | Operations | FEI |
|---|---|---|---|
| MERCK SERONO SA | AubonneSwitzerland | Analytical testing, Active ingredient (API) manufacture, Labelling, Finished drug manufacture, Packaging | 3002807447 |
| MERCK SERONO SA | Corsier-sur-VeveySwitzerland | Analytical testing, Active ingredient (API) manufacture | 3003131678 |
| Merck Healthcare KGaA | DarmstadtGermany | Analytical testing, Labelling, Finished drug manufacture, Packaging | 3016570199 |
| MERCK SL | Tres CantosSpain | Analytical testing, Active ingredient (API) manufacture | 3002807505 |
| Merck Sante | CalaisFrance | Analytical testing, Active ingredient (API) manufacture, Labelling, Finished drug manufacture, Packaging | 3002807474 |
| Merck Sante | MeyzieuFrance | Analytical testing, Active ingredient (API) manufacture, Labelling, Finished drug manufacture, Packaging | 3002807502 |
| Merck Sante | SemoyFrance | Analytical testing, Labelling, Finished drug manufacture, Packaging, sterilize | 3002807504 |
| Istituto Di Ricerche Biomediche Antoine Marxer RBM SpA | Colleretto GiacosaItaly | Analytical testing | 3002807307 |
| MERCK SERONO SPA | Guidonia MontecelioItaly | Analytical testing | 3002807252 |
| MERCK SERONO SPA | Modugno (loc. frazione Zona Industriale)Italy | Analytical testing, Labelling, Finished drug manufacture, Packaging | 3003581732 |
| Merck S.A. de C.V. | Naucalpan de JuarezMexico | Analytical testing, Labelling, Finished drug manufacture, Packaging | 3004641553 |
| EMD Serono, Inc. | Boston, MAUnited States | Finished drug manufacture | 1220970 |
Exclusivity
Patents
11Unexpired Orange Book patents where this company is the application holder.
| Product | Active ingredient | Expiry |
|---|---|---|
| MAVENCLAD | CLADRIBINE | Nov 2038 |
| MAVENCLAD | CLADRIBINE | Sept 2041 |
| TEPMETKO | TEPOTINIB HYDROCHLORIDE | Apr 2028 |
| TEPMETKO | TEPOTINIB HYDROCHLORIDE | May 2028 |
| TEPMETKO | TEPOTINIB HYDROCHLORIDE | Jul 2028 |
| TEPMETKO | TEPOTINIB HYDROCHLORIDE | Jul 2028 |
| TEPMETKO | TEPOTINIB HYDROCHLORIDE | Oct 2029 |
| TEPMETKO | TEPOTINIB HYDROCHLORIDE | Mar 2030 |
Catalogue
Marketed products
18Showing 18 of 18.
| Brand | Generic name | Form | Category |
|---|---|---|---|
| BAVENCIO | avelumab | INJECTION, SOLUTION, CONCENTRATE | BLA |
| Cetrotide | cetrorelix acetate | KIT | NDA |
| Gonal-f | follitropin alfa | KIT | BLA |
| Gonal-f RFF Redi-ject | FOLLITROPIN | INJECTION, SOLUTION | BLA |
| Gonal-f RFF Redi-ject | FOLLITROPIN | INJECTION, SOLUTION | BLA |
| Gonal-f RFF Redi-ject | FOLLITROPIN | INJECTION, SOLUTION | BLA |
| Mavenclad | Cladribine | TABLET | NDA |
| Ovidrel | choriogonadotropin alfa | INJECTION, SOLUTION | BLA |
| REBIF | INTERFERON BETA-1A | INJECTION, SOLUTION | BLA |
| REBIF | interferon beta-1a | INJECTION, SOLUTION | BLA |
| REBIF REBIDOSE | INTERFERON BETA-1A | KIT | BLA |
| REBIF REBIDOSE | INTERFERON BETA-1A | INJECTION, SOLUTION | BLA |
| REBIF REBIDOSE | INTERFERON BETA-1A | INJECTION, SOLUTION | BLA |
| Rebif | interferon beta-1a | KIT | BLA |
| Serostim | somatropin | KIT | BLA |
| Serostim | somatropin | KIT | BLA |
| Serostim | somatropin | KIT | BLA |
| TEPMETKO | Tepotinib Hydrochloride | TABLET | NDA |
Provenance
Facility and operations data from the FDA Drug Establishments Current Registration Site. Product data from the openFDA National Drug Code Directory. Patent and exclusivity data from the FDA Orange Book. Shortage data from the FDA drug shortage database. Contact details the FDA publishes for registered establishments are deliberately not reproduced here. This entry is compiled from public records and has not been claimed by the company.