Register entry
- Registered sites
- 9
- Active NDC listings
- 176
- Labeller names
- 12
- Live patents
- 0
- Countries
- 2
- Base
- India
Authorisation
Registered operations
Analytical testing9Active ingredient (API) manufacture7Labelling1Finished drug manufacture4Packaging4Repackaging1
Sites
Registered establishments
9| Establishment | Address | Registered for | FEI / DUNS |
|---|---|---|---|
| Biocon Biosphere LimitedRegistrant: Biocon Limited | Plot No. 95, Visakha Pharmacity, SEZ, Jawaharlal Nehru Pharma City, Paravada (M), Anakapalli, Andhra Pradesh 531021, India (IND) | Analytical testing, Active ingredient (API) manufacture | 3022125340565270798 |
| Biocon Limited | Plot No: 02, Road No: 21, Jawaharlal Nehru Pharma City, Thadi Village, IDA Paravada (M), Anakapalli, Andhra Pradesh 531019, India (IND) | Analytical testing, Active ingredient (API) manufacture | 3006400591915899220 |
| BIOCON PHARMA LIMITED | Special Economic Zone, Block F1, Plot No.5, Phase IV, Bommasandra - Jigani Link Road, Bommasandra Post, Bengaluru, Karnataka 560099, India (IND) | Analytical testing, Finished drug manufacture, Packaging, Repackaging | 3013637926871412155 |
| Biocon Biologics Limited | Block No, B1,B2, B3, B5, Q13 of Q1 and W20 & Unit S18,1st Floor,Block B4, SEZ, Plot No.2,3,4&5, Phase IV, Bommasandra-Jigani Link Road, Bengaluru, Karnataka 560099, India (IND) | Analytical testing, Finished drug manufacture, Packaging | 3003981475650501997 |
| Biocon Biologics Limited | Block No. M1, M2 and M6, Q1 (QC3 and QC10) and W3, 20th KM Hosur Road, Electronics City, Bengaluru, Karnataka 560100, India (IND) | Analytical testing, Active ingredient (API) manufacture, Finished drug manufacture, Packaging | 3015283245675486243 |
| Biocon Limited | 20th KM, Hosur Road, Electronics City, Bengaluru, Karnataka 560100, India (IND) | Analytical testing, Active ingredient (API) manufacture | 1000172912650173537 |
| Biocon Limited | Special Economic Zone, Plot No. 2, 3, 4 & 5, Phase IV, Bommasandra-Jigani Link Road, Bommasandra Post, Bengaluru, Karnataka 560099, India (IND) | Analytical testing, Active ingredient (API) manufacture | 3010164491915076162 |
| Biocon Limited | Plot No. 213-215 and 216/B, Phase II IDA, Pashamylaram, Sangareddy, Telangana 502307, India (IND) | Analytical testing, Active ingredient (API) manufacture | 3004956855916728337 |
| BIOCON SDN.BHD.Registrant: Biocon Biologics Limited | No. 1, Jalan Bioteknologi 1, Kawasan Perindustrian SiLC, Iskander Puteri, Johor 79200, Malaysia (MYS) | Analytical testing, Active ingredient (API) manufacture, Labelling, Finished drug manufacture, Packaging | 3011248248865785591 |
Catalogue
Drug listings by form and route
176176 active NDC listings: 113 human prescription drug, 63 bulk ingredient. By marketing category: ANDA 88, BULK INGREDIENT 62, BLA 25, BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING 1.
| Dosage form | NDCs |
|---|---|
| powder | 63 |
| tablet, film coated | 34 |
| capsule | 17 |
| tablet | 17 |
| injection, solution | 12 |
| injection | 6 |
| kit | 6 |
| injection, powder, lyophilized, for solution | 5 |
| tablet, delayed release | 4 |
| tablet, for suspension | 3 |
| capsule, delayed release | 2 |
| solution | 2 |
| suspension | 2 |
| injection, solution, concentrate | 1 |
| powder, for suspension | 1 |
| Route | NDCs |
|---|---|
| oral | 82 |
| subcutaneous | 15 |
| intravenous | 10 |
| intravascular | 2 |
| intravitreal | 1 |
| Labeller name on the listing | NDCs |
|---|---|
| biocon pharma inc. | 68 |
| biocon limited | 54 |
| biocon biologics inc. | 20 |
| biocon pharma inc | 6 |
| biocon pharma inc., | 6 |
| biocon biologics inc | 5 |
| biocon pharma inc, | 5 |
| biocon limited | 4 |
| biocon limited | 4 |
| biocon pharma inc., | 2 |
| biocon biologics limited | 1 |
| biocon pharma inc. | 1 |
Catalogue
Marketed products
176Showing 150 of 176.
| Brand | Generic name | Form / route | NDC |
|---|---|---|---|
| AMINOCAPROIC ACID | AMINOCAPROIC ACID | tablet, oral | 70377-102ANDA |
| AMINOCAPROIC ACID | AMINOCAPROIC ACID | tablet, oral | 70377-103ANDA |
| AMINOCAPROIC ACID | AMINOCAPROIC ACID | solution, oral | 70377-104ANDA |
| AUKELSO | Denosumab-kyqq | injection, subcutaneous | 83257-030BLA |
| Adalimumab | adalimumab-fkjp | kit | 83257-020BLA |
| Adalimumab | adalimumab-fkjp | kit | 83257-021BLA |
| Adalimumab | adalimumab-fkjp | kit | 83257-022BLA |
| - | Anidulafungin | powder | 65727-072BULK INGREDIENT |
| - | Apixaban | powder | 65727-081BULK INGREDIENT |
| Atorvastatin Calcium | atorvastatin calcium | tablet, film coated, oral | 70377-077ANDA |
| Atorvastatin Calcium | atorvastatin calcium | tablet, film coated, oral | 70377-078ANDA |
| Atorvastatin Calcium | atorvastatin calcium | tablet, film coated, oral | 70377-079ANDA |
| Atorvastatin Calcium | atorvastatin calcium | tablet, film coated, oral | 70377-080ANDA |
| - | Atorvastatin calcium crystalline | powder | 65727-004BULK INGREDIENT |
| BOSAYA | Denosumab-kyqq | injection, subcutaneous | 83257-029BLA |
| - | Brinzolamide | powder | 65727-033BULK INGREDIENT |
| - | Cabozantinib-(S)-Malate | powder | 65727-091BULK INGREDIENT |
| - | DABIGATRAN ETEXILATE MESYLATE | powder | 65727-105BULK INGREDIENT |
| DAPAGLIFLOZIN | DAPAGLIFLOZIN | tablet, film coated, oral | 70377-023ANDA |
| DAPAGLIFLOZIN | DAPAGLIFLOZIN | tablet, film coated, oral | 70377-024ANDA |
| - | Dabigatran | powder | 65727-049BULK INGREDIENT |
| - | Dapagliflozin | powder | 65727-073BULK INGREDIENT |
| - | Dapagliflozin Propane Diol | powder | 65727-092BULK INGREDIENT |
| Daptomycin | Daptomycin | injection, powder, lyophilized, for solution, intravenous | 70377-093ANDA |
| Dasatinib | dasatinib | tablet, film coated, oral | 70377-083ANDA |
| Dasatinib | dasatinib | tablet, film coated, oral | 70377-084ANDA |
| Dasatinib | dasatinib | tablet, film coated, oral | 70377-085ANDA |
| Dasatinib | dasatinib | tablet, film coated, oral | 70377-086ANDA |
| Dasatinib | dasatinib | tablet, film coated, oral | 70377-087ANDA |
| Dasatinib | dasatinib | tablet, film coated, oral | 70377-088ANDA |
| - | Dasatinib monohydrate | powder | 65727-088BULK INGREDIENT |
| - | Deferasirox | powder | 65727-037BULK INGREDIENT |
| EVEROLIMUS | everolimus | tablet, oral | 70377-010ANDA |
| EVEROLIMUS | everolimus | tablet, oral | 70377-011ANDA |
| EVEROLIMUS | everolimus | tablet, oral | 70377-012ANDA |
| EVEROLIMUS | everolimus | tablet, oral | 70377-013ANDA |
| - | Edoxaban Tosylate Monohydrate | powder | 65727-113BULK INGREDIENT |
| Eltrombopag | Eltrombopag | tablet, film coated, oral | 70377-183ANDA |
| Eltrombopag | eltrombopag olamine | tablet, film coated, oral | 70377-184ANDA |
| Eltrombopag | eltrombopag olamine | tablet, film coated, oral | 70377-185ANDA |
| Eltrombopag | eltrombopag olamine | tablet, film coated, oral | 70377-186ANDA |
| - | Eltrombopag Olamine | powder | 65727-098BULK INGREDIENT |
| - | Empagliflozin | powder | 65727-085BULK INGREDIENT |
| - | Enzalutamide | powder | 65727-110BULK INGREDIENT |
| - | Everolimus | powder | 65727-046BULK INGREDIENT |
| - | Everolimus | powder | 65727-063BULK INGREDIENT |
| - | Everolimus | powder | 65727-064BULK INGREDIENT |
| Everolimus | Everolimus | tablet, oral | 70377-069ANDA |
| Everolimus | EVEROLIMUS | tablet, oral | 70377-070ANDA |
| Everolimus | everolimus | tablet, oral | 70377-071ANDA |
| Everolimus | Everolimus | tablet, for suspension, oral | 70377-090ANDA |
| Everolimus | Everolimus | tablet, for suspension, oral | 70377-091ANDA |
| Everolimus | Everolimus | tablet, for suspension, oral | 70377-092ANDA |
| Everolimus | everolimus | tablet, oral | 70377-112ANDA |
| - | Everolimus Premix 2 % | powder | 65727-086BULK INGREDIENT |
| FAMOTIDINE | FAMOTIDINE | powder, for suspension, oral | 70377-113ANDA |
| FINGOLIMOD | FINGOLIMOD | capsule, oral | 70377-019ANDA |
| - | Fidaxomicin | powder | 65727-027BULK INGREDIENT |
| - | Fingolimod hydrochloride | powder | 65727-036BULK INGREDIENT |
| - | Fluvastatin Sodium | powder | 65727-012BULK INGREDIENT |
| - | Fluvastatin sodium Amorphous | powder | 65727-017BULK INGREDIENT |
| Fulphila | pegfilgrastim-jmdb | injection, subcutaneous | 83257-005BLA |
| - | Glatiramer acetate | powder | 65727-038BULK INGREDIENT |
| HULIO | adalimumab-fkjp | kit | 83257-016BLA |
| HULIO | adalimumab-fkjp | kit | 83257-019BLA |
| INSULIN DILUTING MEDIUM FOR Kirsty | water | injection, solution, intravenous, subcutaneous | 83257-006BLA |
| - | Insulin | powder | 82196-020BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING |
| Insulin Glargine | insulin Glargine-yfgn | injection, solution, subcutaneous | 83257-014BLA |
| Insulin Glargine | insulin Glargine-yfgn | injection, solution, subcutaneous | 83257-015BLA |
| - | Ivacaftor | powder | 65727-095BULK INGREDIENT |
| JOBEVNE | bevacizumab-nwgd | injection, intravascular | 83257-009BLA |
| JOBEVNE | bevacizumab-nwgd | injection, intravascular | 83257-010BLA |
| KIRSTY | insulin aspart-xjhz | injection, solution, intravenous, subcutaneous | 83257-007BLA |
| KIRSTY | insulin aspart-xjhz | injection, solution, intravenous, subcutaneous | 83257-008BLA |
| - | LURASIDONE HYDROCHLORIDE | powder | 65727-096BULK INGREDIENT |
| Labetalol Hydrochloride | Labetalol Hydrochloride | tablet, film coated, oral | 70377-060ANDA |
| Labetalol Hydrochloride | Labetalol Hydrochloride | tablet, film coated, oral | 70377-061ANDA |
| Labetalol Hydrochloride | Labetalol Hydrochloride | tablet, film coated, oral | 70377-062ANDA |
| Labetalol Hydrochloride | Labetalol Hydrochloride | tablet, film coated, oral | 70377-063ANDA |
| - | Lenalidomide | powder | 65727-084BULK INGREDIENT |
| Lenalidomide | Lenalidomide | capsule, oral | 70377-049ANDA |
| Lenalidomide | Lenalidomide | capsule, oral | 70377-050ANDA |
| Lenalidomide | Lenalidomide | capsule, oral | 70377-051ANDA |
| Lenalidomide | Lenalidomide | capsule, oral | 70377-052ANDA |
| Lenalidomide | Lenalidomide | capsule, oral | 70377-053ANDA |
| Lenalidomide | Lenalidomide | capsule, oral | 70377-054ANDA |
| - | Lenalidomide hemihydrate | powder | 65727-097BULK INGREDIENT |
| - | Linagliptin | powder | 65727-057BULK INGREDIENT |
| Liothyronine sodium | Liothyronine sodium | tablet, oral | 70377-114ANDA |
| Liothyronine sodium | Liothyronine sodium | tablet, oral | 70377-115ANDA |
| Liothyronine sodium | Liothyronine sodium | tablet, oral | 70377-116ANDA |
| - | Liraglutide | powder | 65727-087BULK INGREDIENT |
| Liraglutide | liraglutide | injection, subcutaneous | 70377-094ANDA |
| Liraglutide | liraglutide | injection, solution, subcutaneous | 70377-095ANDA |
| MICAFUNGIN | micafungin | injection, powder, lyophilized, for solution, intravenous | 70377-075ANDA |
| MICAFUNGIN | micafungin | injection, powder, lyophilized, for solution, intravenous | 70377-076ANDA |
| - | Micafungin sodium | powder | 65727-055BULK INGREDIENT |
| - | Mirabegron | powder | 65727-048BULK INGREDIENT |
| - | Mycophenolate Mofetil | powder | 65727-005BULK INGREDIENT |
| - | Mycophenolate Sodium | powder | 65727-019BULK INGREDIENT |
| - | Mycophenolic Acid | powder | 65727-011BULK INGREDIENT |
| Mycophenolic Acid | Mycophenolic Acid | tablet, delayed release, oral | 70377-039ANDA |
| Mycophenolic Acid | Mycophenolic Acid | tablet, delayed release, oral | 70377-040ANDA |
| Mycophenolic Acid | Mycophenolic Acid | tablet, delayed release, oral | 70377-126ANDA |
| Mycophenolic Acid | Mycophenolic Acid | tablet, delayed release, oral | 70377-127ANDA |
| NITROFURANTOIN | NITROFURANTOIN | suspension, oral | 70377-118ANDA |
| NOREPINEPHRINE BITARTRATE | NOREPINEPHRINE BITARTRATE | injection, solution, concentrate, intravenous | 70377-121ANDA |
| - | Nintedanib Esylate | powder | 65727-104BULK INGREDIENT |
| OGIVRI | trastuzumab-dkst | injection, powder, lyophilized, for solution, intravenous | 83257-001BLA |
| OGIVRI | trastuzumab-dkst | injection, powder, lyophilized, for solution, intravenous | 83257-003BLA |
| OGIVRI | trastuzumab-dkst | kit | 83257-004BLA |
| - | OLAPARIB | powder | 65727-103BULK INGREDIENT |
| - | ORLISTST | powder | 65727-015BULK INGREDIENT |
| OXCARBAZEPINE | OXCARBAZEPINE | suspension, oral | 70377-117ANDA |
| - | Orlistat pellets | powder | 65727-093BULK INGREDIENT |
| - | Pimecrolimus | powder | 65727-045BULK INGREDIENT |
| - | Posaconazole | powder | 65727-059BULK INGREDIENT |
| - | Posaconazole (Form- 1) | powder | 65727-107BULK INGREDIENT |
| - | Pravastatin Sodium | powder | 65727-003BULK INGREDIENT |
| Pravastatin sodium | Pravastatin sodium | tablet, oral | 70377-045ANDA |
| Pravastatin sodium | Pravastatin sodium | tablet, oral | 70377-046ANDA |
| Pravastatin sodium | Pravastatin sodium | tablet, oral | 70377-047ANDA |
| Pravastatin sodium | Pravastatin sodium | tablet, oral | 70377-048ANDA |
| Prazosin hydrochloride | Prazosin hydrochloride | capsule, oral | 70377-066ANDA |
| Prazosin hydrochloride | Prazosin hydrochloride | capsule, oral | 70377-067ANDA |
| Prazosin hydrochloride | Prazosin hydrochloride | capsule, oral | 70377-068ANDA |
| - | Relugolix | powder | 65727-111BULK INGREDIENT |
| - | Repaglinide | powder | 65727-010BULK INGREDIENT |
| - | Rivaroxaban | powder | 65727-050BULK INGREDIENT |
| - | Rosuvastatin Calcium | powder | 65727-028BULK INGREDIENT |
| Rosuvastatin calcium | Rosuvastatin calcium | tablet, film coated, oral | 70377-006ANDA |
| Rosuvastatin calcium | Rosuvastatin calcium | tablet, film coated, oral | 70377-007ANDA |
| Rosuvastatin calcium | Rosuvastatin calcium | tablet, film coated, oral | 70377-008ANDA |
| Rosuvastatin calcium | Rosuvastatin calcium | tablet, film coated, oral | 70377-009ANDA |
| SEMGLEE | insulin glargine-yfgn | injection, solution, subcutaneous | 83257-011BLA |
| SEMGLEE | insulin glargine-yfgn | injection, solution, subcutaneous | 83257-012BLA |
| - | Sacubitril | powder | 65727-079BULK INGREDIENT |
| Sacubitril and Valsartan | Sacubitril and Valsartan | tablet, film coated, oral | 70377-031ANDA |
| Sacubitril and Valsartan | Sacubitril and Valsartan | tablet, film coated, oral | 70377-032ANDA |
| Sacubitril and Valsartan | Sacubitril and Valsartan | tablet, film coated, oral | 70377-033ANDA |
| - | Semaglutide | powder | 65727-094BULK INGREDIENT |
| Sertraline HCl | Sertraline hydrochloride | capsule, oral | 70377-128ANDA |
| Sertraline HCl | Sertraline hydrochloride | capsule, oral | 70377-129ANDA |
| - | Simvastatin | powder | 65727-002BULK INGREDIENT |
| Simvastatin | Simvastatin | tablet, film coated, oral | 70377-001ANDA |
| Simvastatin | Simvastatin | tablet, film coated, oral | 70377-002ANDA |
| Simvastatin | Simvastatin | tablet, film coated, oral | 70377-003ANDA |
| Simvastatin | Simvastatin | tablet, film coated, oral | 70377-004ANDA |
| Simvastatin | Simvastatin | tablet, film coated, oral | 70377-005ANDA |
| - | Sirolimus | powder | 65727-013BULK INGREDIENT |
Neighbours
Registered in the same town
12- Apitoria Pharma Private LimitedAnakapalli, IND; Sangareddy, IND · 6 sites
- LAURUS LABS LIMITEDAnakapalli, IND · 4 sites
- Micro Labs LimitedBengaluru, IND · 4 sites
- Dr. Reddy's Laboratories LimitedSangareddy, IND · 3 sites
- Viyash Scientific LimitedAnakapalli, IND; Sangareddy, IND · 3 sites
- Granules Pharmaceuticals Inc.Anakapalli, IND; Sangareddy, IND · 3 sites
- Syngene International LimitedBengaluru, IND · 3 sites
- Arene Life Sciences Private LimitedSangareddy, IND · 3 sites
- CIPLA PHARMACEUTICALS LIMITEDBengaluru, IND · 2 sites
- Aurobindo Pharma LimitedSangareddy, IND · 2 sites
- EUGIA Pharma Specialities LimitedAnakapalli, IND; Sangareddy, IND · 2 sites
- SHILPA MEDICARE LIMITEDBengaluru, IND · 2 sites
Compare
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- MSN Laboratories Private Limited,8 sites · 275 NDC
- Hetero Labs Limited8 sites · 167 NDC
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- Alembic Pharmaceuticals Limited7 sites · 998 NDC
- CIPLA PHARMACEUTICALS LIMITED7 sites · 368 NDC
- Ipca Laboratories Limited7 sites · 77 NDC
- Indoco Remedies Limited7 sites · 58 NDC
Enquiry
Common questions
- Is Biocon Biologics Limited FDA approved?
- Biocon Biologics Limited holds 9 FDA-registered establishments across 2 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 Biocon Biologics Limited's drugs manufactured?
- At registered sites in India, Malaysia. The FDA register lists Anakapalli; Bengaluru; Sangareddy; Iskander Puteri. Registered operations: analytical testing, active ingredient (API) manufacture, labelling, finished drug manufacture, packaging, repackaging.
- What drugs does Biocon Biologics Limited make?
- 176 products are listed under Biocon Biologics Limited in the openFDA NDC Directory, most often as powder; tablet, film coated; capsule. 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.