Register entry
- Registered sites
- 2
- Active NDC listings
- 24
- Labeller names
- 3
- Live patents
- 111
- Exclusivities
- 1
- Countries
- 1
- Base
- Japan
Authorisation
Registered operations
Analytical testing1Active ingredient (API) manufacture2Labelling2Finished drug manufacture2Packaging2
Sites
Registered establishments
2| Establishment | Address | Registered for | FEI / DUNS |
|---|---|---|---|
| Sumitomo Pharma Co., Ltd. | 2200 Oaza Tsurusaki, Oita, Oita 870-0106, Japan (JPN) | Active ingredient (API) manufacture, Labelling, Finished drug manufacture, Packaging | 3005619533713325350 |
| Sumitomo Pharma Co., Ltd. | 1450 Yasuzuka-cho, Suzuka, Mie 513-0818, Japan (JPN) | Analytical testing, Active ingredient (API) manufacture, Labelling, Finished drug manufacture, Packaging | 3003028650706295235 |
Catalogue
Drug listings by form and route
2424 active NDC listings: 14 human prescription drug, 7 drug for further processing, 3 bulk ingredient. By marketing category: NDA 13, DRUG FOR FURTHER PROCESSING 7, BULK INGREDIENT 3, BLA 1.
| Dosage form | NDCs |
|---|---|
| tablet, film coated | 13 |
| powder | 5 |
| tablet | 4 |
| implant | 1 |
| kit | 1 |
| Route | NDCs |
|---|---|
| oral | 13 |
| intramuscular | 1 |
| Labeller name on the listing | NDCs |
|---|---|
| sumitomo pharma america, inc. | 13 |
| sumitomo pharma co., ltd. | 10 |
| sumitomo pharma america, inc | 1 |
Exclusivity
Patents and exclusivities
111| Patent | Product | Covers | Expiry |
|---|---|---|---|
| 9763954 | APTIOMeslicarbazepine acetate | use | Sept 2028 |
| 10912781 | APTIOMeslicarbazepine acetate | product | Oct 2028 |
| 9566244 | APTIOMeslicarbazepine acetate | product | Oct 2028 |
| 9265900 | LONHALA MAGNAIR KITglycopyrrolate | product | Dec 2028 |
| 7300935 | MYFEMBREE, ORGOVYXestradiol; norethindrone acetate; relugolix; relugolix | substance | Jan 2029 |
| 10940110 | LONHALA MAGNAIR KITglycopyrrolate | product | Feb 2029 |
| 8653260 | GEMTESAvibegron | substance | Apr 2029 |
| 10821074 | KYNMOBIapomorphine hydrochloride | product | Aug 2029 |
| 8372431 | APTIOMeslicarbazepine acetate | product | Apr 2030 |
| 10420763 | KYNMOBIapomorphine hydrochloride | product | Jun 2030 |
| 9044475 | KYNMOBIapomorphine hydrochloride | product | Jun 2030 |
| 9283219 | KYNMOBIapomorphine hydrochloride | product | Jun 2030 |
| 9326981 | KYNMOBIapomorphine hydrochloride | use | Jun 2030 |
| 9669019 | KYNMOBIapomorphine hydrochloride | product | Jun 2030 |
| 9669021 | KYNMOBIapomorphine hydrochloride | use | Jun 2030 |
| 9789270 | LONHALA MAGNAIR KITglycopyrrolate | product | Oct 2030 |
| 11419769 | KYNMOBIapomorphine hydrochloride | product | Dec 2031 |
| 8414922 | KYNMOBIapomorphine hydrochloride | product | Dec 2031 |
| 8846074 | KYNMOBIapomorphine hydrochloride | product | Dec 2031 |
| 9750747 | APTIOMeslicarbazepine acetate | use | Aug 2032 |
| 9168556 | LONHALA MAGNAIR KITglycopyrrolate | product | Sept 2032 |
| 9604018 | LONHALA MAGNAIR KITglycopyrrolate | product | May 2033 |
| 11795178 | MYFEMBREE, ORGOVYXestradiol; norethindrone acetate; relugolix; relugolix | substance, product | Sept 2033 |
| 12325714 | MYFEMBREE, ORGOVYXestradiol; norethindrone acetate; relugolix; relugolix | substance, product | Sept 2033 |
| 12180219 | GEMTESAvibegron | substance, product | Mar 2034 |
| 8247415 | GEMTESAvibegron | substance, product | Dec 2034 |
| 10376661 | LONHALA MAGNAIR KITglycopyrrolate | product | Sept 2035 |
| 10350170 | ORGOVYXrelugolix | product | Feb 2036 |
| 10449146 | KYNMOBIapomorphine hydrochloride | use | Apr 2036 |
| 10959943 | KYNMOBIapomorphine hydrochloride | use | Apr 2036 |
| 10688518 | LONHALA MAGNAIR KITglycopyrrolate | product | Nov 2036 |
| 10744277 | LONHALA MAGNAIR KITglycopyrrolate | product | Dec 2036 |
| 10449191 | ORGOVYXrelugolix | use | Sept 2037 |
| 10786501 | ORGOVYXrelugolix | use | Sept 2037 |
| 11033551 | MYFEMBREEestradiol; norethindrone acetate; relugolix | use | Sept 2037 |
| 11583526 | ORGOVYXrelugolix | use | Sept 2037 |
| 11957684 | MYFEMBREEestradiol; norethindrone acetate; relugolix | use | Sept 2037 |
| 12097198 | ORGOVYXrelugolix | use | Sept 2037 |
| 12144809 | ORGOVYXrelugolix | use | Sept 2037 |
| 12336990 | ORGOVYXrelugolix | use | Sept 2037 |
| 12629370 | ORGOVYXrelugolix | use | Sept 2037 |
| 11793812 | MYFEMBREEestradiol; norethindrone acetate; relugolix | use | May 2038 |
| 12102638 | GEMTESAvibegron | use | Mar 2040 |
| 12357636 | GEMTESAvibegron | use | Jul 2042 |
| 12551447 | MYFEMBREEestradiol; norethindrone acetate; relugolix | product | Nov 2042 |
| Product | Exclusivity | Until |
|---|---|---|
| GEMTESAVIBEGRON | I-955 New indication | Dec 2027 |
Catalogue
Marketed products
24| Brand | Generic name | Form / route | NDC |
|---|---|---|---|
| Aptiom | ESLICARBAZEPINE ACETATE | tablet, oral | 63402-202NDA |
| Aptiom | ESLICARBAZEPINE ACETATE | tablet, oral | 63402-204NDA |
| Aptiom | ESLICARBAZEPINE ACETATE | tablet, oral | 63402-206NDA |
| Aptiom | ESLICARBAZEPINE ACETATE | tablet, oral | 63402-208NDA |
| Aptiom | ESLICARBAZEPINE ACETATE | kit, oral | 63402-248NDA |
| - | Droxidopa | powder | 38217-0030DRUG FOR FURTHER PROCESSING |
| GEMTESA | vibegron | tablet, film coated, oral | 73336-075NDA |
| Latuda | lurasidone hydrochloride | tablet, film coated, oral | 63402-302NDA |
| Latuda | lurasidone hydrochloride | tablet, film coated, oral | 63402-304NDA |
| Latuda | lurasidone hydrochloride | tablet, film coated, oral | 63402-306NDA |
| Latuda | lurasidone hydrochloride | tablet, film coated, oral | 63402-308NDA |
| Latuda | lurasidone hydrochloride | tablet, film coated, oral | 63402-312NDA |
| - | Lurasidone hydrochloride | tablet, film coated | 38217-0013DRUG FOR FURTHER PROCESSING |
| - | MEROPENEM | powder | 38217-0020BULK INGREDIENT |
| - | Meropenem | powder | 38217-0021DRUG FOR FURTHER PROCESSING |
| Myfembree | relugolix, estradiol hemihydrate, and norethindrone acetate | tablet, film coated, oral | 72974-415NDA |
| Orgovyx | relugolix | tablet, film coated, oral | 72974-120NDA |
| RETHYMIC | allogenic thymocyte-depleted thymus tissue-agdc | implant, intramuscular | 72359-001BLA |
| - | Zonisamide | powder | 38217-0040BULK INGREDIENT |
| - | lurasidone hydrochloride | powder | 38217-0010BULK INGREDIENT |
| - | lurasidone hydrochloride | tablet, film coated | 38217-0011DRUG FOR FURTHER PROCESSING |
| - | lurasidone hydrochloride | tablet, film coated | 38217-0012DRUG FOR FURTHER PROCESSING |
| - | lurasidone hydrochloride | tablet, film coated | 38217-0014DRUG FOR FURTHER PROCESSING |
| - | lurasidone hydrochloride | tablet, film coated | 38217-0015DRUG FOR FURTHER PROCESSING |
Neighbours
Registered in the same town
2- Sumitomo Chemical Company, LimitedOita, JPN
- Sumika Chemical Analysis Service, Ltd.Oita, JPN
Compare
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Enquiry
Common questions
- Is Sumitomo Pharma Co., Ltd. FDA approved?
- Sumitomo Pharma Co., Ltd. holds 2 FDA-registered establishments in Japan. 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 Sumitomo Pharma Co., Ltd.'s drugs manufactured?
- The FDA register lists Oita; Suzuka. Registered operations: analytical testing, active ingredient (API) manufacture, labelling, finished drug manufacture, packaging.
- What drugs does Sumitomo Pharma Co., Ltd. make?
- 24 products are listed under Sumitomo Pharma Co., Ltd. in the openFDA NDC Directory, most often as tablet, film coated; powder; 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.