Register entry
Bora Pharmaceutical Laboratories Inc.
Data as of · How to read this entry
- Registered sites
- 5
- Active NDC listings
- 15
- Labeller names
- 2
- Live patents
- 0
- Countries
- 3
- Base
- United States
Authorisation
Registered operations
Analytical testing5Active ingredient (API) manufacture1Labelling3Finished drug manufacture4Packaging4
Sites
Registered establishments
5| Establishment | Address | Registered for | FEI / DUNS |
|---|---|---|---|
| Bora Pharmaceutical Services Inc | 7333 Mississauga Rd, Mississauga, Ontario L5N 6L4, Canada (CAN) | Analytical testing, Labelling, Finished drug manufacture, Packaging | 3002807086205556368 |
| Bora Pharmaceutical Laboratories Inc. Zhongli Plant Building IIRegistrant: Bora Pharmaceutical Laboratories Inc. | 3-1, Ziqiang 4th Rd., Zhongli Dist., Taoyuan City, 320023, Taiwan (TWN) | Analytical testing, Finished drug manufacture, Packaging | 3005674517658863394 |
| Bora Pharmaceutical Laboratories Inc. | No. 1, Kedong 3rd Rd., Hsinchu Science Park, Zhunan Township, Miaoli County 350401, Taiwan (TWN) | Analytical testing, Labelling, Finished drug manufacture, Packaging | 3007184570656139511 |
| Bora Pharmaceuticals Inc. | 6701 Evenstad Drive N, Maple Grove, Minnesota (MN) 55369-6026, United States (USA) | Analytical testing, Labelling, Finished drug manufacture, Packaging | 3004106442119296421 |
| Bora Biologics USA, LLC | 9704 Medical Center Dr, Rockville, Maryland (MD) 20850-3343, United States (USA) | Analytical testing, Active ingredient (API) manufacture | 3010195035145072247 |
Catalogue
Drug listings by form and route
1515 active NDC listings: 15 drug for further processing. By marketing category: DRUG FOR FURTHER PROCESSING 15.
| Dosage form | NDCs |
|---|---|
| tablet, film coated | 7 |
| capsule, extended release | 4 |
| aerosol, metered | 2 |
| capsule | 1 |
| gel | 1 |
| Route | NDCs |
|---|
| Labeller name on the listing | NDCs |
|---|---|
| bora pharmaceutical services inc. | 14 |
| bora pharmaceutical services inc. | 1 |
Catalogue
Marketed products
15| Brand | Generic name | Form / route | NDC |
|---|---|---|---|
| - | Carvedilol Phosphate | capsule, extended release | 53873-083DRUG FOR FURTHER PROCESSING |
| - | Carvedilol Phosphate | capsule, extended release | 53873-084DRUG FOR FURTHER PROCESSING |
| - | Carvedilol Phosphate | capsule, extended release | 53873-085DRUG FOR FURTHER PROCESSING |
| - | Carvedilol Phosphate | capsule, extended release | 53873-086DRUG FOR FURTHER PROCESSING |
| - | Fluticasone propionate | aerosol, metered | 53873-078DRUG FOR FURTHER PROCESSING |
| - | Fluticasone propionate | aerosol, metered | 53873-079DRUG FOR FURTHER PROCESSING |
| - | Lamivudine | tablet, film coated | 53873-073DRUG FOR FURTHER PROCESSING |
| - | Lamivudine | tablet, film coated | 53873-074DRUG FOR FURTHER PROCESSING |
| - | Zidovudine | capsule | 53873-070DRUG FOR FURTHER PROCESSING |
| - | atovaquone and proguanil hydrochloride | tablet, film coated | 53873-071DRUG FOR FURTHER PROCESSING |
| - | atovaquone and proguanil hydrochloride | tablet, film coated | 53873-072DRUG FOR FURTHER PROCESSING |
| - | diclofenac sodium | gel | 53873-080DRUG FOR FURTHER PROCESSING |
| - | sumatriptan | tablet, film coated | 53873-057DRUG FOR FURTHER PROCESSING |
| - | sumatriptan | tablet, film coated | 53873-058DRUG FOR FURTHER PROCESSING |
| - | sumatriptan | tablet, film coated | 53873-059DRUG FOR FURTHER PROCESSING |
Neighbours
Registered in the same town
12- Contract Pharmaceuticals Limited CanadaMississauga, CAN · 2 sites
- Resilience Biotechnologies Inc.Mississauga, CAN · 2 sites
- Patheon Manufacturing Services LLCMississauga, CAN
- SGS North America Inc.Mississauga, CAN
- Sigma-Aldrich CorporationRockville, MD
- PCI Pharma Services Canada, Inc.Mississauga, CAN
- PhibroChemTaoyuan City, TWN
- AdiraMedica IncMississauga, CAN
- Element Materials Technology Pharma US LLCMississauga, CAN
- PLZ CorpMississauga, CAN
- ProMed Pharma, LLCMaple Grove, MN
- Samsung Biologics Co., Ltd.Rockville, MD
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Enquiry
Common questions
- Is Bora Pharmaceutical Laboratories Inc. FDA approved?
- Bora Pharmaceutical Laboratories Inc. holds 5 FDA-registered establishments across 3 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 Bora Pharmaceutical Laboratories Inc.'s drugs manufactured?
- At registered sites in Canada, Taiwan, the United States. The FDA register lists Mississauga; Taoyuan City; Zhunan Township; Maple Grove, MN; Rockville, MD. Registered operations: analytical testing, active ingredient (API) manufacture, labelling, finished drug manufacture, packaging.
- What drugs does Bora Pharmaceutical Laboratories Inc. make?
- 15 products are listed under Bora Pharmaceutical Laboratories Inc. in the openFDA NDC Directory, most often as tablet, film coated; capsule, extended release; aerosol, metered. 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.