Register entry
Hainan Shuangcheng Pharmaceuticals Co., Ltd.
Data as of · How to read this entry
- Registered sites
- 1
- Active NDC listings
- 8
- Live patents
- 0
- Countries
- 1
- Base
- China
Authorisation
Registered operations
Analytical testing1Active ingredient (API) manufacture1Labelling1Finished drug manufacture1Packaging1sterilize1
Sites
Registered establishments
1| Establishment | Address | Registered for | FEI / DUNS |
|---|---|---|---|
| Hainan Shuangcheng Pharmaceuticals Co., Ltd. | No. 16 Xingguo Road, Xiuying District, Haikou City, Hainan Province 570314, China (CHN) | Analytical testing, Active ingredient (API) manufacture, Labelling, Finished drug manufacture, Packaging, sterilize | 3009010397421282282 |
Catalogue
Drug listings by form and route
88 active NDC listings: 4 bulk ingredient, 4 human prescription drug. By marketing category: ANDA 4, BULK INGREDIENT 4.
| Dosage form | NDCs |
|---|---|
| powder | 4 |
| injection, solution | 3 |
| injection, powder, lyophilized, for solution | 1 |
| Route | NDCs |
|---|---|
| intravenous | 4 |
| subcutaneous | 1 |
| Labeller name on the listing | NDCs |
|---|---|
| hainan shuangcheng pharmaceuticals co., ltd. | 8 |
Catalogue
Marketed products
8| Brand | Generic name | Form / route | NDC |
|---|---|---|---|
| Bivalirudin | Bivalirudin | injection, powder, lyophilized, for solution, intravenous | 52958-034ANDA |
| - | Bivalirudin | powder | 52958-112BULK INGREDIENT |
| - | Eptifibatide | powder | 52958-001BULK INGREDIENT |
| Eptifibatide | Eptifibatide | injection, solution, intravenous | 52958-040ANDA |
| Eptifibatide | Eptifibatide | injection, solution, intravenous | 52958-402ANDA |
| OCTREOTIDE ACETATE | octreotide acetate | injection, solution, intravenous, subcutaneous | 52958-046ANDA |
| - | bortezomib | powder | 52958-134BULK INGREDIENT |
| - | octreotide acetate | powder | 52958-117BULK INGREDIENT |
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Enquiry
Common questions
- Is Hainan Shuangcheng Pharmaceuticals Co., Ltd. FDA approved?
- Hainan Shuangcheng Pharmaceuticals Co., Ltd. holds 1 FDA-registered establishment in China. 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 Hainan Shuangcheng Pharmaceuticals Co., Ltd.'s drugs manufactured?
- The FDA register lists Haikou City. Registered operations: analytical testing, active ingredient (API) manufacture, labelling, finished drug manufacture, packaging, sterilize.
- What drugs does Hainan Shuangcheng Pharmaceuticals Co., Ltd. make?
- 8 products are listed under Hainan Shuangcheng Pharmaceuticals Co., Ltd. in the openFDA NDC Directory, most often as powder; injection, solution; injection, powder, lyophilized, for 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.