Drug factory · FDA FEI 3008377265
Be Biosol Private Limited
Plot No. 4, Sy No. 542/P, Biotech Park, Phase II, Kolthur Village, Shamirpet Mandal, Medchal-Malkajgiri, India
Problems found, fixed voluntarily at FDA's last inspection, Nov 12, 2024.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
3 drug inspections on record since 2019: 0 with no problems, 3 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Aprepitant | Makes it and tests it | BE Pharmaceuticals Inc., Cipla USA., Inc. | 71839-104, 69097-830 |
| Dalbavancin | Makes it, tests it, packages it and labels it | BE Pharmaceuticals Inc., Somerset Therapeutics, LLC | 71839-144, 70069-830 |
| Daptomycin | Makes it and tests it | BE Pharmaceuticals Inc., Camber Pharmaceuticals Inc., Cipla USA., Inc. | 71839-107, 71839-108, 31722-102 +2 |
| Enoxaparin | Makes it and tests it | BE Pharmaceuticals Inc. | 71839-109, 71839-110, 71839-111 +4 |
| Heparin | Makes it and tests it | BE Pharmaceuticals Inc. | 71839-117, 71839-118 |
| Neostigmine | Makes it and tests it | BE Pharmaceuticals Inc., Camber Pharmaceuticals Inc. | 71839-105, 71839-106, 31722-994 +1 |
| Nitroprusside | Makes it and tests it | BE Pharmaceuticals Inc. | 71839-120 |
| Succinylcholine | Makes it, tests it, packages it and labels it | BE Pharmaceuticals Inc., Nordic Pharma, Inc. | 71839-121, 69918-700 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Nov 12, 2024 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Apr 26, 2024 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Aug 2, 2019 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
Registered with FDA for: analysis; api manufacture; label; manufacture; pack.