Register entry
- Registered sites
- 12
- Active NDC listings
- 18
- Live patents
- 11
- Exclusivities
- 1
- Countries
- 7
- Base
- France
Authorisation
Registered operations
Analytical testing11Active ingredient (API) manufacture5Labelling7Finished drug manufacture8Packaging7sterilize1
Sites
Registered establishments
12| Establishment | Address | Registered for | FEI / DUNS |
|---|---|---|---|
| MERCK SERONO SARegistrant: EMD Serono, Inc. | Zone Industrielle de l'Ouriettaz, Aubonne, Vaud 1170, Switzerland (CHE) | Analytical testing, Active ingredient (API) manufacture, Labelling, Finished drug manufacture, Packaging | 3002807447480192579 |
| MERCK SERONO SARegistrant: EMD Serono, Inc. | Z.I.B. Route de Fenil 25, Corsier-sur-Vevey, Vaud 1804, Switzerland (CHE) | Analytical testing, Active ingredient (API) manufacture | 3003131678488437302 |
| Merck Healthcare KGaARegistrant: EMD Serono, Inc. | Frankfurter Str. 250, Darmstadt, 64293, Germany (DEU) | Analytical testing, Labelling, Finished drug manufacture, Packaging | 3016570199314174946 |
| MERCK SLRegistrant: EMD Serono, Inc. | CALLE DE BATANES 1, Tres Cantos, Madrid 28760, Spain (ESP) | Analytical testing, Active ingredient (API) manufacture | 3002807505464946485 |
| Merck SanteRegistrant: EMD Serono, Inc. | 5 Rue Clement Ader, Calais, 62100, France (FRA) | Analytical testing, Active ingredient (API) manufacture, Labelling, Finished drug manufacture, Packaging | 3002807474384668138 |
| Merck SanteRegistrant: EMD Serono, Inc. | Zone Industrielle 10 Av Du Mal de Lattre de Tassigny, Meyzieu, 69330, France (FRA) | Analytical testing, Active ingredient (API) manufacture, Labelling, Finished drug manufacture, Packaging | 3002807502384953134 |
| Merck SanteRegistrant: EMD Serono, Inc. | 2 rue du Pressoir Vert, Semoy, Loiret 45400, France (FRA) | Analytical testing, Labelling, Finished drug manufacture, Packaging, sterilize | 3002807504384668112 |
| Istituto Di Ricerche Biomediche Antoine Marxer RBM SpARegistrant: EMD Serono, Inc. | VIA RIBES, 1, Colleretto Giacosa, Torino 10010, Italy (ITA) | Analytical testing | 3002807307436298533 |
| MERCK SERONO SPARegistrant: EMD Serono, Inc. | VIA LUIGI EINAUDI 11, Guidonia Montecelio, Roma 00012, Italy (ITA) | Analytical testing | 3002807252339654002 |
| MERCK SERONO SPARegistrant: EMD Serono, Inc. | Via delle Magnolie 15, Modugno (loc. frazione Zona Industriale), Bari 70026, Italy (ITA) | Analytical testing, Labelling, Finished drug manufacture, Packaging | 3003581732437803088 |
| Merck S.A. de C.V.Registrant: EMD Serono, Inc. | Calle 5. No. 7, Fraccionamiento Industrial Alce Blanco, Naucalpan de Juarez, 53370, Mexico (MEX) | Analytical testing, Labelling, Finished drug manufacture, Packaging | 3004641553810006213 |
| EMD Serono, Inc. | 200 Pier 4 Blvd., Ste.300, Boston, Massachusetts (MA) 02210-2457, United States (USA) | Finished drug manufacture | 1220970088514898 |
Catalogue
Drug listings by form and route
1818 active NDC listings: 18 human prescription drug. By marketing category: BLA 15, NDA 3.
| Dosage form | NDCs |
|---|---|
| injection, solution | 8 |
| kit | 7 |
| tablet | 2 |
| injection, solution, concentrate | 1 |
| Route | NDCs |
|---|---|
| subcutaneous | 15 |
| oral | 2 |
| intravenous | 1 |
| Labeller name on the listing | NDCs |
|---|---|
| emd serono, inc. | 18 |
Exclusivity
Patents and exclusivities
11| Patent | Product | Covers | Expiry |
|---|---|---|---|
| 9284300 | TEPMETKOtepotinib hydrochloride | product | Apr 2028 |
| 8921357 | TEPMETKOtepotinib hydrochloride | substance, product | May 2028 |
| 8658643 | TEPMETKOtepotinib hydrochloride | use | Jul 2028 |
| 9062029 | TEPMETKOtepotinib hydrochloride | product | Jul 2028 |
| 9403799 | TEPMETKOtepotinib hydrochloride | use | Jul 2028 |
| 8927540 | TEPMETKOtepotinib hydrochloride | use | Jul 2028 |
| 8329692 | TEPMETKOtepotinib hydrochloride | substance, product | Oct 2029 |
| 8580781 | TEPMETKOtepotinib hydrochloride | substance, product | Mar 2030 |
| 10849919 | MAVENCLADcladribine | use | Nov 2038 |
| 12533408 | MAVENCLADcladribine | use | Sept 2041 |
| 12539329 | MAVENCLADcladribine | use | Sept 2041 |
| Product | Exclusivity | Until |
|---|---|---|
| TEPMETKOTEPOTINIB HYDROCHLORIDE | ODE-325 Orphan drug | Feb 2028 |
Catalogue
Marketed products
18| Brand | Generic name | Form / route | NDC |
|---|---|---|---|
| BAVENCIO | avelumab | injection, solution, concentrate, intravenous | 44087-3535BLA |
| Cetrotide | cetrorelix acetate | kit, subcutaneous | 44087-1225NDA |
| Gonal-f | follitropin alfa | kit, subcutaneous | 44087-9030BLA |
| Gonal-f RFF Redi-ject | FOLLITROPIN | injection, solution, subcutaneous | 44087-1115BLA |
| Gonal-f RFF Redi-ject | FOLLITROPIN | injection, solution, subcutaneous | 44087-1116BLA |
| Gonal-f RFF Redi-ject | FOLLITROPIN | injection, solution, subcutaneous | 44087-1117BLA |
| Mavenclad | Cladribine | tablet, oral | 44087-4000NDA |
| Ovidrel | choriogonadotropin alfa | injection, solution, subcutaneous | 44087-1150BLA |
| REBIF | INTERFERON BETA-1A | injection, solution, subcutaneous | 44087-0022BLA |
| REBIF | interferon beta-1a | injection, solution, subcutaneous | 44087-0044BLA |
| REBIF REBIDOSE | INTERFERON BETA-1A | kit, subcutaneous | 44087-0188BLA |
| REBIF REBIDOSE | INTERFERON BETA-1A | injection, solution, subcutaneous | 44087-3322BLA |
| REBIF REBIDOSE | INTERFERON BETA-1A | injection, solution, subcutaneous | 44087-3344BLA |
| Rebif | interferon beta-1a | kit, subcutaneous | 44087-8822BLA |
| Serostim | somatropin | kit, subcutaneous | 44087-0004BLA |
| Serostim | somatropin | kit, subcutaneous | 44087-0005BLA |
| Serostim | somatropin | kit, subcutaneous | 44087-0006BLA |
| TEPMETKO | Tepotinib Hydrochloride | tablet, oral | 44087-5000NDA |
Neighbours
Registered in the same town
10- The Procter & Gamble Manufacturing CompanyNaucalpan de Juarez, MEX
- BRACCO DIAGNOSTICS INCCOLLERETTO GIACOSA, ITA
- Spectrum Pharmaceuticals, Inc.Boston, MA
- Advanced Accelerator Applications USA, Inc.Colleretto Giacosa, ITA
- MassBiologicsBoston, MA
- Merck KGaADarmstadt, DEU
- Zealand Pharma A/SBoston, MA
- BRIGHAM AND WOMEN`S HOSPITAL, INC., THEBoston, MA
- Massachusetts General Hospital, TheBoston, MA
- Vertex Pharmaceuticals IncorporatedBoston, MA
Compare
Comparable companies in France
- Sanofi12 sites · 3 NDC
- LFB USA Inc.6 sites · 0 NDC
- Boiron Inc.5 sites · 2,088 NDC
- EUROAPI5 sites · 41 NDC
- Sanofi Vaccines US Inc.5 sites · 25 NDC
- PCAS3 sites · 20 NDC
- Pierre Fabre Pharmaceuticals, Inc.3 sites · 13 NDC
- Unither Manufacturing LLC3 sites · 6 NDC
- Boehringer Ingelheim Animal Health USA Inc.3 sites · 0 NDC
- Ethypharm3 sites · 0 NDC
Enquiry
Common questions
- Is EMD Serono, Inc. FDA approved?
- EMD Serono, Inc. holds 12 FDA-registered establishments across 7 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 EMD Serono, Inc.'s drugs manufactured?
- At registered sites in Switzerland, Germany, Spain, France, Italy, Mexico and 1 other countries. The FDA register lists Aubonne; Corsier-sur-Vevey; Darmstadt; Tres Cantos; Calais; Meyzieu, and 6 more. Registered operations: analytical testing, active ingredient (API) manufacture, labelling, finished drug manufacture, packaging, sterilize.
- What drugs does EMD Serono, Inc. make?
- 18 products are listed under EMD Serono, Inc. in the openFDA NDC Directory, most often as injection, solution; kit; tablet. 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.