Register entry
Biocon Biologics Limited
- Registered sites
- 9
- Drug products
- 172
- Live patents
- 0
- Countries
- 2
- Base
- India
Authorisation
Registered operations
What the FDA has registered these sites to do. This is the regulatory record, not a marketing claim.
Analytical testingActive ingredient (API) manufactureLabellingFinished drug manufacturePackagingRepackaging
Sites
Facilities
9| Site | Location | Operations | FEI |
|---|---|---|---|
| Biocon Biosphere Limited | AnakapalliIndia | Analytical testing, Active ingredient (API) manufacture | 3022125340 |
| Biocon Limited | AnakapalliIndia | Analytical testing, Active ingredient (API) manufacture | 3006400591 |
| BIOCON PHARMA LIMITED | BengaluruIndia | Analytical testing, Finished drug manufacture, Packaging, Repackaging | 3013637926 |
| Biocon Biologics Limited | BengaluruIndia | Analytical testing, Finished drug manufacture, Packaging | 3003981475 |
| Biocon Biologics Limited | BengaluruIndia | Analytical testing, Active ingredient (API) manufacture, Finished drug manufacture, Packaging | 3015283245 |
| Biocon Limited | BengaluruIndia | Analytical testing, Active ingredient (API) manufacture | 1000172912 |
| Biocon Limited | BengaluruIndia | Analytical testing, Active ingredient (API) manufacture | 3010164491 |
| Biocon Limited | SangareddyIndia | Analytical testing, Active ingredient (API) manufacture | 3004956855 |
| BIOCON SDN.BHD. | Iskander PuteriMalaysia | Analytical testing, Active ingredient (API) manufacture, Labelling, Finished drug manufacture, Packaging | 3011248248 |
Catalogue
Marketed products
172Showing 150 of 172.
| Brand | Generic name | Form | Category |
|---|---|---|---|
| AMINOCAPROIC ACID | AMINOCAPROIC ACID | TABLET | ANDA |
| AMINOCAPROIC ACID | AMINOCAPROIC ACID | TABLET | ANDA |
| AMINOCAPROIC ACID | AMINOCAPROIC ACID | SOLUTION | ANDA |
| AUKELSO | Denosumab-kyqq | INJECTION | BLA |
| Adalimumab | adalimumab-fkjp | KIT | BLA |
| Adalimumab | adalimumab-fkjp | KIT | BLA |
| Adalimumab | adalimumab-fkjp | KIT | BLA |
| - | Anidulafungin | POWDER | BULK INGREDIENT |
| - | Apixaban | POWDER | BULK INGREDIENT |
| Atorvastatin Calcium | atorvastatin calcium | TABLET, FILM COATED | ANDA |
| Atorvastatin Calcium | atorvastatin calcium | TABLET, FILM COATED | ANDA |
| Atorvastatin Calcium | atorvastatin calcium | TABLET, FILM COATED | ANDA |
| Atorvastatin Calcium | atorvastatin calcium | TABLET, FILM COATED | ANDA |
| - | Atorvastatin calcium crystalline | POWDER | BULK INGREDIENT |
| BOSAYA | Denosumab-kyqq | INJECTION | BLA |
| - | Brinzolamide | POWDER | BULK INGREDIENT |
| - | Cabozantinib-(S)-Malate | POWDER | BULK INGREDIENT |
| - | DABIGATRAN ETEXILATE MESYLATE | POWDER | BULK INGREDIENT |
| DAPAGLIFLOZIN | DAPAGLIFLOZIN | TABLET, FILM COATED | ANDA |
| DAPAGLIFLOZIN | DAPAGLIFLOZIN | TABLET, FILM COATED | ANDA |
| - | Dabigatran | POWDER | BULK INGREDIENT |
| - | Dapagliflozin | POWDER | BULK INGREDIENT |
| - | Dapagliflozin Propane Diol | POWDER | BULK INGREDIENT |
| Daptomycin | Daptomycin | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | ANDA |
| Dasatinib | dasatinib | TABLET, FILM COATED | ANDA |
| Dasatinib | dasatinib | TABLET, FILM COATED | ANDA |
| Dasatinib | dasatinib | TABLET, FILM COATED | ANDA |
| Dasatinib | dasatinib | TABLET, FILM COATED | ANDA |
| Dasatinib | dasatinib | TABLET, FILM COATED | ANDA |
| Dasatinib | dasatinib | TABLET, FILM COATED | ANDA |
| - | Dasatinib monohydrate | POWDER | BULK INGREDIENT |
| - | Deferasirox | POWDER | BULK INGREDIENT |
| EVEROLIMUS | everolimus | TABLET | ANDA |
| EVEROLIMUS | everolimus | TABLET | ANDA |
| EVEROLIMUS | everolimus | TABLET | ANDA |
| EVEROLIMUS | everolimus | TABLET | ANDA |
| - | Edoxaban Tosylate Monohydrate | POWDER | BULK INGREDIENT |
| - | Eltrombopag Olamine | POWDER | BULK INGREDIENT |
| - | Empagliflozin | POWDER | BULK INGREDIENT |
| - | Enzalutamide | POWDER | BULK INGREDIENT |
| - | Everolimus | POWDER | BULK INGREDIENT |
| - | Everolimus | POWDER | BULK INGREDIENT |
| - | Everolimus | POWDER | BULK INGREDIENT |
| Everolimus | Everolimus | TABLET | ANDA |
| Everolimus | EVEROLIMUS | TABLET | ANDA |
| Everolimus | everolimus | TABLET | ANDA |
| Everolimus | Everolimus | TABLET, FOR SUSPENSION | ANDA |
| Everolimus | Everolimus | TABLET, FOR SUSPENSION | ANDA |
| Everolimus | Everolimus | TABLET, FOR SUSPENSION | ANDA |
| Everolimus | everolimus | TABLET | ANDA |
| - | Everolimus Premix 2 % | POWDER | BULK INGREDIENT |
| FAMOTIDINE | FAMOTIDINE | POWDER, FOR SUSPENSION | ANDA |
| FINGOLIMOD | FINGOLIMOD | CAPSULE | ANDA |
| - | Fidaxomicin | POWDER | BULK INGREDIENT |
| - | Fingolimod hydrochloride | POWDER | BULK INGREDIENT |
| - | Fluvastatin Sodium | POWDER | BULK INGREDIENT |
| - | Fluvastatin sodium Amorphous | POWDER | BULK INGREDIENT |
| Fulphila | pegfilgrastim-jmdb | INJECTION | BLA |
| - | Glatiramer acetate | POWDER | BULK INGREDIENT |
| HULIO | adalimumab-fkjp | KIT | BLA |
| HULIO | adalimumab-fkjp | KIT | BLA |
| INSULIN DILUTING MEDIUM FOR Kirsty | water | INJECTION, SOLUTION | BLA |
| - | Insulin | POWDER | BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING |
| Insulin Glargine | insulin Glargine-yfgn | INJECTION, SOLUTION | BLA |
| Insulin Glargine | insulin Glargine-yfgn | INJECTION, SOLUTION | BLA |
| - | Ivacaftor | POWDER | BULK INGREDIENT |
| JOBEVNE | bevacizumab-nwgd | INJECTION | BLA |
| JOBEVNE | bevacizumab-nwgd | INJECTION | BLA |
| KIRSTY | insulin aspart-xjhz | INJECTION, SOLUTION | BLA |
| KIRSTY | insulin aspart-xjhz | INJECTION, SOLUTION | BLA |
| - | LURASIDONE HYDROCHLORIDE | POWDER | BULK INGREDIENT |
| Labetalol Hydrochloride | Labetalol Hydrochloride | TABLET, FILM COATED | ANDA |
| Labetalol Hydrochloride | Labetalol Hydrochloride | TABLET, FILM COATED | ANDA |
| Labetalol Hydrochloride | Labetalol Hydrochloride | TABLET, FILM COATED | ANDA |
| Labetalol Hydrochloride | Labetalol Hydrochloride | TABLET, FILM COATED | ANDA |
| - | Lenalidomide | POWDER | BULK INGREDIENT |
| Lenalidomide | Lenalidomide | CAPSULE | ANDA |
| Lenalidomide | Lenalidomide | CAPSULE | ANDA |
| Lenalidomide | Lenalidomide | CAPSULE | ANDA |
| Lenalidomide | Lenalidomide | CAPSULE | ANDA |
| Lenalidomide | Lenalidomide | CAPSULE | ANDA |
| Lenalidomide | Lenalidomide | CAPSULE | ANDA |
| - | Lenalidomide hemihydrate | POWDER | BULK INGREDIENT |
| - | Linagliptin | POWDER | BULK INGREDIENT |
| Liothyronine sodium | Liothyronine sodium | TABLET | ANDA |
| Liothyronine sodium | Liothyronine sodium | TABLET | ANDA |
| Liothyronine sodium | Liothyronine sodium | TABLET | ANDA |
| - | Liraglutide | POWDER | BULK INGREDIENT |
| Liraglutide | liraglutide | INJECTION | ANDA |
| Liraglutide | liraglutide | INJECTION, SOLUTION | ANDA |
| MICAFUNGIN | micafungin | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | ANDA |
| MICAFUNGIN | micafungin | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | ANDA |
| - | Micafungin sodium | POWDER | BULK INGREDIENT |
| - | Mirabegron | POWDER | BULK INGREDIENT |
| - | Mycophenolate Mofetil | POWDER | BULK INGREDIENT |
| - | Mycophenolate Sodium | POWDER | BULK INGREDIENT |
| - | Mycophenolic Acid | POWDER | BULK INGREDIENT |
| Mycophenolic Acid | Mycophenolic Acid | TABLET, DELAYED RELEASE | ANDA |
| Mycophenolic Acid | Mycophenolic Acid | TABLET, DELAYED RELEASE | ANDA |
| Mycophenolic Acid | Mycophenolic Acid | TABLET, DELAYED RELEASE | ANDA |
| Mycophenolic Acid | Mycophenolic Acid | TABLET, DELAYED RELEASE | ANDA |
| NITROFURANTOIN | NITROFURANTOIN | SUSPENSION | ANDA |
| NOREPINEPHRINE BITARTRATE | NOREPINEPHRINE BITARTRATE | INJECTION, SOLUTION, CONCENTRATE | ANDA |
| - | Nintedanib Esylate | POWDER | BULK INGREDIENT |
| OGIVRI | trastuzumab-dkst | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | BLA |
| OGIVRI | trastuzumab-dkst | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | BLA |
| OGIVRI | trastuzumab-dkst | KIT | BLA |
| - | OLAPARIB | POWDER | BULK INGREDIENT |
| - | ORLISTST | POWDER | BULK INGREDIENT |
| OXCARBAZEPINE | OXCARBAZEPINE | SUSPENSION | ANDA |
| - | Orlistat pellets | POWDER | BULK INGREDIENT |
| - | Pimecrolimus | POWDER | BULK INGREDIENT |
| - | Posaconazole | POWDER | BULK INGREDIENT |
| - | Posaconazole (Form- 1) | POWDER | BULK INGREDIENT |
| - | Pravastatin Sodium | POWDER | BULK INGREDIENT |
| Pravastatin sodium | Pravastatin sodium | TABLET | ANDA |
| Pravastatin sodium | Pravastatin sodium | TABLET | ANDA |
| Pravastatin sodium | Pravastatin sodium | TABLET | ANDA |
| Pravastatin sodium | Pravastatin sodium | TABLET | ANDA |
| Prazosin hydrochloride | Prazosin hydrochloride | CAPSULE | ANDA |
| Prazosin hydrochloride | Prazosin hydrochloride | CAPSULE | ANDA |
| Prazosin hydrochloride | Prazosin hydrochloride | CAPSULE | ANDA |
| - | Relugolix | POWDER | BULK INGREDIENT |
| - | Repaglinide | POWDER | BULK INGREDIENT |
| - | Rivaroxaban | POWDER | BULK INGREDIENT |
| - | Rosuvastatin Calcium | POWDER | BULK INGREDIENT |
| Rosuvastatin calcium | Rosuvastatin calcium | TABLET, FILM COATED | ANDA |
| Rosuvastatin calcium | Rosuvastatin calcium | TABLET, FILM COATED | ANDA |
| Rosuvastatin calcium | Rosuvastatin calcium | TABLET, FILM COATED | ANDA |
| Rosuvastatin calcium | Rosuvastatin calcium | TABLET, FILM COATED | ANDA |
| SEMGLEE | insulin glargine-yfgn | INJECTION, SOLUTION | BLA |
| SEMGLEE | insulin glargine-yfgn | INJECTION, SOLUTION | BLA |
| - | Sacubitril | POWDER | BULK INGREDIENT |
| Sacubitril and Valsartan | Sacubitril and Valsartan | TABLET, FILM COATED | ANDA |
| Sacubitril and Valsartan | Sacubitril and Valsartan | TABLET, FILM COATED | ANDA |
| Sacubitril and Valsartan | Sacubitril and Valsartan | TABLET, FILM COATED | ANDA |
| - | Semaglutide | POWDER | BULK INGREDIENT |
| Sertraline HCl | Sertraline hydrochloride | CAPSULE | ANDA |
| Sertraline HCl | Sertraline hydrochloride | CAPSULE | ANDA |
| - | Simvastatin | POWDER | BULK INGREDIENT |
| Simvastatin | Simvastatin | TABLET, FILM COATED | ANDA |
| Simvastatin | Simvastatin | TABLET, FILM COATED | ANDA |
| Simvastatin | Simvastatin | TABLET, FILM COATED | ANDA |
| Simvastatin | Simvastatin | TABLET, FILM COATED | ANDA |
| Simvastatin | Simvastatin | TABLET, FILM COATED | ANDA |
| - | Sirolimus | POWDER | BULK INGREDIENT |
| - | Sitagliptin hydrochloride | POWDER | BULK INGREDIENT |
| - | Sitagliptin phosphate | POWDER | BULK INGREDIENT |
| - | Sitagliptin phosphate monohydrate | POWDER | BULK INGREDIENT |
| - | TIRZEPATIDE | POWDER | BULK INGREDIENT |
Provenance
Facility and operations data from the FDA Drug Establishments Current Registration Site. Product data from the openFDA National Drug Code Directory. Patent and exclusivity data from the FDA Orange Book. Shortage data from the FDA drug shortage database. Contact details the FDA publishes for registered establishments are deliberately not reproduced here. This entry is compiled from public records and has not been claimed by the company.