Register entryShortage reported
- Registered sites
- 1
- Active NDC listings
- 27
- Labeller names
- 3
- Live patents
- 0
- Shortage listings
- 1
- Countries
- 1
- Base
- China
Authorisation
Registered operations
Analytical testing1Active ingredient (API) manufacture1Labelling1Finished drug manufacture1Packaging1
Sites
Registered establishments
1| Establishment | Address | Registered for | FEI / DUNS |
|---|---|---|---|
| Hainan Poly Pharm. Co., Ltd. | Guilinyang Economic Development Zone, Meilan District, Haikou, Hainan 571127, China (CHN) | Analytical testing, Active ingredient (API) manufacture, Labelling, Finished drug manufacture, Packaging | 3005115952654561638 |
Alert
Drug shortage listings
1| Drug | Presentation | Status | Availability | Posted / updated |
|---|---|---|---|---|
| Dobutamine Hydrochloride InjectionCardiovascular, Pediatric, Renal | Dobutamine Hydrochloride, Injection, 250 mg/20 mL (NDC 70436-203-80) | Current | Available | 6 Nov 201716 Sept 2026 |
Catalogue
Drug listings by form and route
2727 active NDC listings: 15 human prescription drug, 12 bulk ingredient. By marketing category: ANDA 15, BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING 12.
| Dosage form | NDCs |
|---|---|
| powder | 12 |
| injection, solution | 6 |
| injection | 4 |
| injection, powder, for solution | 3 |
| injection, powder, lyophilized, for suspension | 1 |
| injection, solution, concentrate | 1 |
| Route | NDCs |
|---|---|
| intravenous | 15 |
| Labeller name on the listing | NDCs |
|---|---|
| hainan poly pharm. co., ltd. | 25 |
| hainan poly pharm., co., ltd. | 1 |
| hainan poly pharm.co., ltd. | 1 |
Catalogue
Marketed products
27| Brand | Generic name | Form / route | NDC |
|---|---|---|---|
| - | Allopurinol | powder | 14335-530BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING |
| - | Apremilast | powder | 14335-433BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING |
| Brivaracetam | brivaracetam | injection, intravenous | 14335-420ANDA |
| - | Crisaborole | powder | 14335-700BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING |
| - | Cyclophosphamide | powder | 14335-360BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING |
| Cyclophosphamide | Cyclophosphamide for Injection | injection, powder, for solution, intravenous | 14335-470ANDA |
| Cyclophosphamide | Cyclophosphamide for Injection | injection, powder, for solution, intravenous | 14335-471ANDA |
| Cyclophosphamide | Cyclophosphamide for Injection | injection, powder, for solution, intravenous | 14335-472ANDA |
| - | Gadobutrol | powder | 14335-580BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING |
| - | Gadoteridol | powder | 14335-390BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING |
| - | Ioversol | powder | 14335-590BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING |
| LEVOLEUCOVORIN CALCIUM | levoleucovorin injection | injection, solution, intravenous | 14335-340ANDA |
| LEVOLEUCOVORIN CALCIUM | levoleucovorin injection | injection, solution, intravenous | 14335-341ANDA |
| - | Memantine Hydrochloride | powder | 14335-160BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING |
| Phenylephrine Hydrochloride | Phenylephrine Hydrochloride | injection, intravenous | 14335-440ANDA |
| Phenylephrine Hydrochloride | Phenylephrine Hydrochloride | injection, intravenous | 14335-441ANDA |
| Phenylephrine Hydrochloride | Phenylephrine Hydrochloride | injection, intravenous | 14335-442ANDA |
| - | Semaglutide | powder | 14335-790BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING |
| - | Sodium Nitroprusside | powder | 14335-130BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING |
| Sodium Nitroprusside | Sodium Nitroprusside | injection, solution, intravenous | 14335-132ANDA |
| Sodium Nitroprusside | Sodium Nitroprusside | injection, solution, intravenous | 14335-133ANDA |
| Sodium Nitroprusside | Sodium Nitroprusside | injection, solution, intravenous | 14335-134ANDA |
| - | Tecovirimat Monohydrate | powder | 14335-680BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING |
| VORICONAZOLE | VORICONAZOLE | injection, solution, intravenous | 14335-730ANDA |
| - | Voriconazole | powder | 14335-450BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING |
| daptomycin | daptomycin | injection, powder, lyophilized, for suspension, intravenous | 14335-120ANDA |
| sodium nitroprusside | sodium nitroprusside | injection, solution, concentrate, intravenous | 14335-131ANDA |
Compare
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Enquiry
Common questions
- Is Hainan Poly Pharm. Co., Ltd. FDA approved?
- Hainan Poly Pharm. 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 Poly Pharm. Co., Ltd.'s drugs manufactured?
- The FDA register lists Haikou. Registered operations: analytical testing, active ingredient (API) manufacture, labelling, finished drug manufacture, packaging.
- What drugs does Hainan Poly Pharm. Co., Ltd. make?
- 27 products are listed under Hainan Poly Pharm. Co., Ltd. in the openFDA NDC Directory, most often as powder; injection, solution; injection. The full breakdown by dosage form and route is above. A listing count is not a sales figure.
- Are any Hainan Poly Pharm. Co., Ltd. products in shortage?
- 1 presentation is currently listed in the FDA drug shortage database under Hainan Poly Pharm. Co., Ltd., covering Dobutamine Hydrochloride Injection.
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.