Register entry
- Registered sites
- 1
- Active NDC listings
- 180
- Labeller names
- 5
- Live patents
- 0
- Countries
- 1
- Base
- India
Authorisation
Registered operations
Analytical testing1Labelling1Finished drug manufacture1Packaging1
Sites
Registered establishments
1| Establishment | Address | Registered for | FEI / DUNS |
|---|---|---|---|
| OrBion Pharmaceuticals Private LimitedRegistrant: Bionpharma Inc. | Plot No.B5 (Part) and B6 (Part), SIPCOT Industrial Park, Irungattukottai, Sriperumbudur, Kancheepuram, TAMIL NADU 602117, India (IND) | Analytical testing, Labelling, Finished drug manufacture, Packaging | 3004540907854403569 |
Catalogue
Drug listings by form and route
180180 active NDC listings: 121 human prescription drug, 55 human otc drug, 4 drug for further processing. By marketing category: ANDA 141, OTC MONOGRAPH DRUG 28, NDA 7, DRUG FOR FURTHER PROCESSING 4.
| Dosage form | NDCs |
|---|---|
| tablet, film coated | 38 |
| capsule, liquid filled | 34 |
| tablet | 29 |
| capsule | 27 |
| liquid | 9 |
| solution | 9 |
| tablet, orally disintegrating | 8 |
| tablet, delayed release | 6 |
| suspension | 5 |
| tablet, for suspension | 3 |
| capsule, extended release | 2 |
| gel | 2 |
| ointment | 2 |
| powder, for suspension | 2 |
| cream | 1 |
| Route | NDCs |
|---|---|
| oral | 165 |
| topical | 10 |
| auricular (otic) | 1 |
| Labeller name on the listing | NDCs |
|---|---|
| bionpharma inc. | 139 |
| bionpharma inc. | 22 |
| bionpharma inc., | 11 |
| bionpharma, inc. | 6 |
| bionpharma inc | 2 |
Catalogue
Marketed products
181Showing 150 of 181.
| Brand | Generic name | Form / route | NDC |
|---|---|---|---|
| A Health Itch Relief Gel | Itch Relief Gel | gel, topical | 69452-376OTC MONOGRAPH DRUG |
| A Health Itch Relief Gel | Itch Relief Gel | gel, topical | 69452-496OTC MONOGRAPH DRUG |
| Acamprosate Calcium | Acamprosate Calcium | tablet, delayed release, oral | 69452-353ANDA |
| - | Acetaminophen and Ibuprofen | tablet, film coated | 69452-307DRUG FOR FURTHER PROCESSING |
| Acetaminophen and Ibuprofen | Acetaminophen and Ibuprofen | tablet, film coated, oral | 69452-394ANDA |
| Acetaminophen and Ibuprofen | Acetaminophen and Ibuprofen | tablet, film coated, oral | 69452-469ANDA |
| Acyclovir | Acyclovir | tablet, oral | 69452-290ANDA |
| Acyclovir | Acyclovir | tablet, oral | 69452-291ANDA |
| Allergy Relief | Diphenhydramine HCl | tablet, oral | 69452-444OTC MONOGRAPH DRUG |
| Allergy Relief | Diphenhydramine HCl | tablet, oral | 69452-445OTC MONOGRAPH DRUG |
| Allergy Relief | Diphenhydramine HCl | capsule, liquid filled, oral | 69452-452OTC MONOGRAPH DRUG |
| Allergy Relief | Diphenhydramine HCl | capsule, liquid filled, oral | 69452-453OTC MONOGRAPH DRUG |
| Amantadine HCl | AMANTADINE HYDROCHLORIDE | capsule, liquid filled, oral | 69452-142ANDA |
| Aripiprazole | Aripiprazole | tablet, orally disintegrating, oral | 69452-338ANDA |
| Aripiprazole | Aripiprazole | tablet, orally disintegrating, oral | 69452-339ANDA |
| Atovaquone | Atovaquone | suspension, oral | 69452-252ANDA |
| - | Azithromycin | tablet, film coated | 69452-171DRUG FOR FURTHER PROCESSING |
| - | Azithromycin | tablet, film coated | 69452-172DRUG FOR FURTHER PROCESSING |
| Azithromycin | Azithromycin | tablet, film coated, oral | 69452-173ANDA |
| Benzonatate | Benzonatate | capsule, oral | 69452-143ANDA |
| Benzonatate | Benzonatate | capsule, oral | 69452-144ANDA |
| Brompheniramine Maleate, Pseudoephedrine Hydrochloride, and Dextromethorphan Hydrobromide | BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE, and DEXTROMETHORPHAN HYDROBROMIDE | syrup, oral | 69452-478ANDA |
| CARBAMAZEPINE | CARBAMAZEPINE | tablet, oral | 69452-312ANDA |
| CETIRIZINE HYDROCHLORIDE | CETIRIZINE HYDROCHLORIDE | tablet, film coated, oral | 69452-465ANDA |
| CEVIMELINE | CEVIMELINE HYDROCHLORIDE | capsule, oral | 69452-316ANDA |
| COLESEVELAM HYDROCHLORIDE | colesevelam hydrochloride | tablet, film coated, oral | 69452-158ANDA |
| COLESEVELAM HYDROCHLORIDE | colesevelam hydrochloride | tablet, oral | 69452-493ANDA |
| Calcitriol | Calcitriol | capsule, liquid filled, oral | 69452-207ANDA |
| Calcitriol | Calcitriol | capsule, liquid filled, oral | 69452-208ANDA |
| Castor Oil | Castor Oil | liquid, oral | 69452-487OTC MONOGRAPH DRUG |
| Cetirizine HCl | Cetirizine HCl | capsule, oral | 69452-265NDA |
| Cetirizine HCl | Cetirizine HCl | capsule, oral | 69452-479NDA |
| Cetirizine Hydrochloride | Cetirizine Hydrochloride | solution, oral | 69452-426ANDA |
| Cimetidine | cimetidine | tablet, film coated, oral | 69452-323ANDA |
| Cimetidine | cimetidine | tablet, film coated, oral | 69452-324ANDA |
| Cimetidine | cimetidine | tablet, film coated, oral | 69452-325ANDA |
| Cimetidine | cimetidine | tablet, film coated, oral | 69452-326ANDA |
| Clobazam | Clobazam | suspension, oral | 69452-116ANDA |
| DROXIDOPA | DROXIDOPA | capsule, oral | 69452-256ANDA |
| DROXIDOPA | DROXIDOPA | capsule, oral | 69452-257ANDA |
| DROXIDOPA | DROXIDOPA | capsule, oral | 69452-258ANDA |
| Deferasirox | deferasirox | tablet, for suspension, oral | 69452-159ANDA |
| Deferasirox | deferasirox | tablet, for suspension, oral | 69452-160ANDA |
| Deferasirox | deferasirox | tablet, for suspension, oral | 69452-161ANDA |
| Desloratadine | Desloratadine | tablet, film coated, oral | 69452-363ANDA |
| Dexamethasone | Dexamethasone | tablet, oral | 69452-276ANDA |
| Dexamethasone | Dexamethasone | tablet, oral | 69452-277ANDA |
| Dexamethasone | Dexamethasone | tablet, oral | 69452-278ANDA |
| Dextromethorphan HBr | Dextromethorphan HBr | capsule, liquid filled, oral | 69452-573OTC MONOGRAPH DRUG |
| Dicyclomine Hydrochloride | Dicyclomine Hydrochloride | tablet, oral | 69452-311ANDA |
| Dofetilide | Dofetilide | capsule, oral | 69452-131ANDA |
| Dofetilide | Dofetilide | capsule, oral | 69452-132ANDA |
| Dofetilide | Dofetilide | capsule, oral | 69452-133ANDA |
| Doxylamine succinate and Pyridoxine hydrochloride | Doxylamine succinate and Pyridoxine hydrochloride | tablet, delayed release, oral | 69452-206ANDA |
| ESZOPICLONE | ESZOPICLONE | tablet, film coated, oral | 69452-347ANDA |
| ESZOPICLONE | ESZOPICLONE | tablet, film coated, oral | 69452-348ANDA |
| ESZOPICLONE | ESZOPICLONE | tablet, film coated, oral | 69452-349ANDA |
| Enalapril maleate oral solution | Enalapril maleate | solution, oral | 69452-237ANDA |
| Ergocalciferol | Ergocalciferol | capsule, liquid filled, oral | 69452-151ANDA |
| Ethosuximide | Ethosuximide | capsule, liquid filled, oral | 69452-152ANDA |
| Fluvoxamine Maleate | Fluvoxamine Maleate | capsule, extended release, oral | 69452-182ANDA |
| Fluvoxamine Maleate | Fluvoxamine Maleate | capsule, extended release, oral | 69452-183ANDA |
| Fluvoxamine maleate | Fluvoxamine maleate | tablet, film coated, oral | 69452-287ANDA |
| Fluvoxamine maleate | Fluvoxamine maleate | tablet, oral | 69452-288ANDA |
| Fluvoxamine maleate | Fluvoxamine maleate | tablet, film coated, oral | 69452-289ANDA |
| Fluvoxamine maleate | Fluvoxamine maleate | tablet, oral | 69452-454ANDA |
| Fluvoxamine maleate | Fluvoxamine maleate | tablet, oral | 69452-455ANDA |
| Granisetron Hydrochloride | Granisetron Hydrochloride | tablet, film coated, oral | 69452-350ANDA |
| Hydroxyzine Hydrochloride | Hydroxyzine Hydrochloride Oral | solution, oral | 69452-395ANDA |
| IBANDRONATE SODIUM | IBANDRONATE SODIUM | tablet, oral | 69452-378ANDA |
| IBUPROFEN, DIPHENHYDRAMINE HCL | IBUPROFEN, DIPHENHYDRAMINE HCL | capsule, liquid filled, oral | 69452-205ANDA |
| Ibuprofen | Ibuprofen | capsule, liquid filled, oral | 69452-212ANDA |
| Ibuprofen | Ibuprofen | capsule, liquid filled, oral | 69452-239ANDA |
| Ibuprofen | Ibuprofen | capsule, liquid filled, oral | 69452-305ANDA |
| Ketorolac Tromethamine | Ketorolac Tromethamine | tablet, film coated, oral | 69452-275ANDA |
| LEVETIRACETAM | LEVETIRACETAM | solution, oral | 69452-412ANDA |
| LORATADINE | LORATADINE | capsule, liquid filled, oral | 69452-211ANDA |
| LORATADINE | LORATADINE | capsule, liquid filled, oral | 69452-283ANDA |
| Loperamide Hydrochloride | loperamide hydrochloride | capsule, oral | 69452-271ANDA |
| Loperamide hydrochloride and Simethicone | loperamide hydrochloride and simethicone | tablet, oral | 69452-210ANDA |
| Loperamide hydrochloride and Simethicone | loperamide hydrochloride and simethicone | tablet, oral | 69452-531ANDA |
| Magnesium Citrate | Be Health Magnesium Citrate Oral Solution - Lemon | liquid, oral | 69452-389OTC MONOGRAPH DRUG |
| Magnesium Citrate | Be Health Magnesium Citrate Oral Solution - Cherry | liquid, oral | 69452-390OTC MONOGRAPH DRUG |
| Magnesium Citrate | Be Health Magnesium Citrate Oral Solution - Grape | liquid, oral | 69452-391OTC MONOGRAPH DRUG |
| Magnesium Citrate | magnesium citrate oral solution | liquid, oral | 69452-398OTC MONOGRAPH DRUG |
| Metformin Hydrochloride Oral Solution | Metformin Hydrochloride | solution, oral | 69452-380ANDA |
| Methimazole | methimazole | tablet, oral | 69452-328ANDA |
| Methimazole | methimazole | tablet, oral | 69452-329ANDA |
| Migraine Relief | Ibuprofen | capsule, liquid filled, oral | 69452-263ANDA |
| Modafinil | Modafinil | tablet, oral | 69452-342ANDA |
| Modafinil | Modafinil | tablet, oral | 69452-343ANDA |
| Naproxen Sodium | Naproxen Sodium | capsule, liquid filled, oral | 69452-179NDA |
| Naratriptan | Naratriptan | tablet, film coated, oral | 69452-340ANDA |
| Naratriptan | Naratriptan | tablet, film coated, oral | 69452-341ANDA |
| Nicardipine Hydrochloride | Nicardipine Hydrochloride | capsule, oral | 69452-436ANDA |
| Nicardipine Hydrochloride | Nicardipine Hydrochloride | capsule, oral | 69452-437ANDA |
| Nighttime Sleep-Aid | Diphenhydramine HCl | capsule, liquid filled, oral | 69452-427OTC MONOGRAPH DRUG |
| Nighttime Sleep-Aid | Diphenhydramine HCl | capsule, liquid filled, oral | 69452-451OTC MONOGRAPH DRUG |
| Nimodipine | Nimodipine | capsule, liquid filled, oral | 69452-209ANDA |
| Omega-3-Acid Ethyl Ester | omega-3-acid ethyl esters | capsule, liquid filled, oral | 69452-175ANDA |
| Oxcarbazepine | Oxcarbazepine | suspension, oral | 69452-125ANDA |
| PROCHLORPERAZINE MALEATE | Prochlorperazine Maleate | tablet, film coated, oral | 69452-309ANDA |
| PROCHLORPERAZINE MALEATE | Prochlorperazine Maleate | tablet, film coated, oral | 69452-310ANDA |
| PROCHLORPERAZINE MALEATE | Prochlorperazine Maleate | tablet, oral | 69452-471ANDA |
| PROCHLORPERAZINE MALEATE | Prochlorperazine Maleate | tablet, oral | 69452-472ANDA |
| PROGESTERONE | PROGESTERONE | capsule, oral | 69452-148ANDA |
| PROGESTERONE | PROGESTERONE | capsule, oral | 69452-149ANDA |
| PROGESTERONE | PROGESTERONE | capsule, oral | 69452-233ANDA |
| PROGESTERONE | PROGESTERONE | capsule, oral | 69452-234ANDA |
| Paricalcitol | Paricalcitol | capsule, oral | 69452-145ANDA |
| Paricalcitol | Paricalcitol | capsule, oral | 69452-146ANDA |
| Paricalcitol | Paricalcitol | capsule, oral | 69452-147ANDA |
| RIZATRIPTAN BENZOATE | rizatriptan benzoate | tablet, orally disintegrating, oral | 69452-156ANDA |
| RIZATRIPTAN BENZOATE | rizatriptan benzoate | tablet, orally disintegrating, oral | 69452-157ANDA |
| Ropinirole | Ropinirole | tablet, film coated, oral | 69452-356ANDA |
| Ropinirole | Ropinirole | tablet, film coated, oral | 69452-357ANDA |
| Ropinirole | Ropinirole | tablet, film coated, oral | 69452-358ANDA |
| Ropinirole | Ropinirole | tablet, film coated, oral | 69452-359ANDA |
| Ropinirole | Ropinirole | tablet, film coated, oral | 69452-360ANDA |
| Ropinirole | Ropinirole | tablet, film coated, oral | 69452-361ANDA |
| Ropinirole | Ropinirole | tablet, film coated, oral | 69452-362ANDA |
| Rufinamide | Rufinamide | suspension, oral | 69452-223ANDA |
| Sevelamer Carbonate | Sevelamer Carbonate | powder, for suspension, oral | 69452-126ANDA |
| Sevelamer Carbonate | Sevelamer Carbonate | powder, for suspension, oral | 69452-127ANDA |
| Sumatriptan | Sumatriptan | tablet, film coated, oral | 69452-344ANDA |
| Sumatriptan | Sumatriptan | tablet, film coated, oral | 69452-345ANDA |
| Sumatriptan | Sumatriptan | tablet, film coated, oral | 69452-346ANDA |
| TETRABENAZINE | TETRABENAZINE | tablet, oral | 69452-117ANDA |
| TETRABENAZINE | TETRABENAZINE | tablet, oral | 69452-118ANDA |
| Terazosin | Terazosin | capsule, oral | 69452-330ANDA |
| Terazosin | Terazosin | capsule, oral | 69452-331ANDA |
| Terazosin | Terazosin | capsule, oral | 69452-332ANDA |
| Terazosin | Terazosin | capsule, oral | 69452-333ANDA |
| Theophylline | Theophylline | tablet, extended release, oral | 69452-267ANDA |
| Ticagrelor | Ticagrelor | tablet, oral | 69452-508ANDA |
| Ticagrelor | Ticagrelor | tablet, oral | 69452-509ANDA |
| Valproic Acid | Valproic Acid | capsule, liquid filled, oral | 69452-150ANDA |
| Zaleplon | Zaleplon | capsule, oral | 69452-364ANDA |
| Zaleplon | Zaleplon | capsule, oral | 69452-365ANDA |
| anti-diarrheal | LOPERAMIDE HYDROCHLORIDE | capsule, liquid filled, oral | 69452-176NDA |
| anti-diarrheal | LOPERAMIDE HYDROCHLORIDE | capsule, liquid filled, oral | 69452-266NDA |
| cool and heat pain relieving liquid | Menthol | liquid, topical | 69452-375OTC MONOGRAPH DRUG |
| divalproex sodium | divalproex sodium | tablet, delayed release, oral | 69452-433ANDA |
| divalproex sodium | divalproex sodium | tablet, delayed release, oral | 69452-434ANDA |
| divalproex sodium | divalproex sodium | tablet, delayed release, oral | 69452-435ANDA |
| dual action pain reliever | Acetaminophen and Ibuprofen | tablet, film coated, oral | 69452-446ANDA |
| dual action pain reliever | Acetaminophen and Ibuprofen | tablet, film coated, oral | 69452-447ANDA |
| dye-free pain relief | Ibuprofen | capsule, liquid filled, oral | 69452-302ANDA |
| dye-free pain relief | Ibuprofen | capsule, liquid filled, oral | 69452-513ANDA |
| ear drops | Carbamide Peroxide 6.5% | liquid, auricular (otic) | 69452-377OTC MONOGRAPH DRUG |
Neighbours
Registered in the same town
1- Esjay Pharma Private LimitedKancheepuram, IND
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Enquiry
Common questions
- Is Bionpharma Inc. FDA approved?
- Bionpharma Inc. holds 1 FDA-registered establishment in India. 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 Bionpharma Inc.'s drugs manufactured?
- The FDA register lists Kancheepuram. Registered operations: analytical testing, labelling, finished drug manufacture, packaging.
- What drugs does Bionpharma Inc. make?
- 181 products are listed under Bionpharma Inc. in the openFDA NDC Directory, most often as tablet, film coated; capsule, liquid filled; 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.