Medicine
Bortezomib 3.5 mg powder for injection
Bortezomib 3.5 mg powder for injection is a generic prescription medicine for intravenous, subcutaneous use, made by 16 labelers, with its source record on the US FDA register. It is available on request for export supply from India to licensed hospitals, importers and physicians.
Availability
Export supply from India to licensed buyers
Typical lead time
On request
Counted from payment and complete documents
Shipping
Ambient
Unopened vials may be stored at controlled room temperature stored at 20°C to…
Key facts
- Active ingredient (INN)
- Bortezomib
- Brand
- Sold under the generic name
- Strength
- 3.5 mg
- Dosage form
- Powder for injection
- Route
- Intravenous, subcutaneous
- Packs
- 1 vial, 10 vials and 15 more
- Manufacturers
- EugiaIndiaCamber PharmaceuticalsIndiaDr. Reddy's LaboratoriesIndiaBluePoint LaboratoriesNingbo Shuangcheng PharmaceuticalApotexAvenacyFresenius KabiHikma PharmaceuticalsHospira16 labelers on the register
- Origin register
- US FDA, United States
- Storage
- Unopened vials may be stored at controlled room temperature stored at 20°C to 25°C (68°F to 77°F) [USP Controlled room temperature]. Retain in original package to protect from light.
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- L01XG01 Bortezomib
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 19 June 2018
- Identifiers
- RxCUI 402243DailyMed set ID b605b541-4bfd-db3e-9710-11c27f6dee6c, 10f60367-0476-4acd-861b-90c18d4b8164, 41e3de39-8278-4a75-badf-601e4602080d +15NDC 60505-6050, 68001-534, 0409-1700 +14Application ANDA205533, ANDA212958, ANDA208460 +9
Record updated 12 November 2026
Documents available
Documents that can be provided with this medicine. Your regulator may ask for more, and the quote lists the full set.
No document list is recorded for this medicine yet. Tell us which documents your regulator needs (for example a CoA, COPP or GMP certificate) when you request a quote.
Packs
Packs from every labeler of this generic presentation.
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 1 vial, single-dose in 1 carton / 1 injection, powder, lyophilized, for solution in 1 vial, single-dose | 55150-337-01 | EugiaIndia | 2 May 2022 |
| 1 vial, single-dose in 1 carton / 1 injection, powder, lyophilized, for solution in 1 vial, single-dose | 55150-337-02 | EugiaIndia | 2 May 2022 |
| 1 vial, single-dose in 1 carton / 1 injection, powder, lyophilized, for solution in 1 vial, single-dose | 31722-303-31 | Camber PharmaceuticalsIndia | 3 May 2024 |
| 1 vial, single-dose in 1 carton / 1 injection, powder, lyophilized, for solution in 1 vial, single-dose | 43598-426-60 | Dr. Reddy's LaboratoriesIndia | 26 July 2022 |
| 1 vial in 1 carton / 1 injection, powder, lyophilized, for solution in 1 vial | 60505-6050-4 | Apotex | 2 May 2022 |
| 1 vial, single-use in 1 carton / 1 injection, powder, lyophilized, for solution in 1 vial, single-use | 63323-821-10 | Fresenius Kabi | 2 May 2022 |
| 1 vial in 1 carton / 1 injection, powder, lyophilized, for solution in 1 vial | 0143-9098-01 | Hikma Pharmaceuticals | 27 July 2022 |
| 1 vial, single-dose in 1 carton / 1 injection, powder, lyophilized, for solution in 1 vial, single-dose | 0409-1700-01 | Hospira | 27 July 2022 |
| 1 vial, single-dose in 1 carton / 1 injection, powder, lyophilized, for solution in 1 vial, single-dose | 71288-118-10 | Meitheal Pharmaceuticals | 26 July 2022 |
| 10 vial in 1 carton / 1 injection, powder, lyophilized, for solution in 1 vial | 75007-501-31 | Ningbo Shuangcheng Pharmaceutical | 17 December 2025 |
| 1 vial in 1 carton / 1 injection, powder, lyophilized, for solution in 1 vial | 75007-501-32 | Ningbo Shuangcheng Pharmaceutical | 17 December 2025 |
| 1 vial in 1 carton / 1 injection, powder, lyophilized, for solution in 1 vial | 51817-586-01 | Pharmascience | 2 May 2022 |
| 1 vial in 1 carton / 1 injection, powder, lyophilized, for solution in 1 vial | 25021-262-10 | Sagent Pharmaceuticals | 15 May 2025 |
| 1 vial in 1 carton / 1 injection, powder, lyophilized, for solution in 1 vial | 72338-200-01 | Waverley Pharma | 19 June 2018 |
| 1 vial in 1 carton / 1 injection, powder, lyophilized, for solution in 1 vial | 68001-534-36 | BluePoint Laboratories | 31 July 2022 |
| 1 vial in 1 carton / 1 injection, powder, lyophilized, for solution in 1 vial | 68001-540-36 | BluePoint Laboratories | 16 May 2022 |
| 1 vial in 1 carton / 1 injection, powder, lyophilized, for solution in 1 vial | 83634-208-10 | Avenacy | 1 May 2026 |
| 1 vial, single-dose in 1 carton / 1 injection, powder, lyophilized, for solution in 1 vial, single-dose | 72603-270-01 | NorthStar RxLLC | 1 November 2024 |
Status by register
Where this medicine is registered, from the source record and the regulator data we hold. Ask us about a country that is not listed.
Import route
Pick the destination country to see the legal import route, who applies and typical timelines, from our import guide for that country.
Import guides are available for 25 countries. Pick one to see its route summary.
BrazilColombiaEgyptEthiopiaGhanaIraqKazakhstanKenyaAll import guides
Alternatives
Other makers and brands of Bortezomib 3.5 mg powder for injection.
Other strengths and forms of Bortezomib
Clinical summary
Bortezomib is a proteasome inhibitor indicated for treatment of adult patients with multiple myeloma treatment of adult patients with mantle cell lymphoma Multiple Myeloma VELCADE is indicated for the treatment of adult patients with multiple myeloma. MedsAcross supplies Bortezomib for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
Read about BortezomibFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- VELCADE prescribing information (Takeda Pharmaceuticals) · U.S. National Library of Medicine, DailyMed
- Velcade: European public assessment report (EPAR) · European Medicines Agency
- Bortezomib Accord: European public assessment report (EPAR) · European Medicines Agency
Need Bortezomib 3.5 mg powder for injection for your hospital or patient?
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