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MedsAcross

Medicine

Bortezomib 3.5 mg/3.5 mL powder for injection

Bortezomib · Intravenous, subcutaneous
Available on requestPrescription onlyUS FDAGeneric name

Bortezomib 3.5 mg/3.5 mL powder for injection is a generic prescription medicine for intravenous, subcutaneous use, made by 5 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

Available on request

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 25°C (77°F)…

Key facts

Active ingredient (INN)
Bortezomib
Brand
Sold under the generic name
Strength
3.5 mg/3.5 mL
Dosage form
Powder for injection
Route
Intravenous, subcutaneous
Packs
1 vial and 3 more
Manufacturers
Zydus LifesciencesIndiaNovadoz PharmaceuticalsIndiaBluePoint LaboratoriesSinteticaSomerset Therapeutics
Origin register
US FDA, United States
Storage
Unopened vials may be stored at controlled room temperature 25°C (77°F), excursions permitted from 15 to 30°C (59 to 86°F). 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
2 May 2022
Identifiers
RxCUI 402243DailyMed set ID 582c7c0d-fa25-4586-8157-a1e2653d72d9, dc737d3d-2a4e-448a-ad70-e013065c411c, d41340c2-7fe8-42b2-aaa5-c9f9b0e9b50e +3NDC 70771-1708, 70069-836, 72205-183 +3Application ANDA210204, ANDA211898, ANDA209622

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.

PackCodeLabelerMarketed since
1 vial, single-dose in 1 carton / 3.5 mL in 1 vial, single-dose70710-1411-1Zydus LifesciencesIndia2 May 2022
1 vial, single-dose in 1 carton / 3.5 mL in 1 vial, single-dose70771-1708-1Zydus LifesciencesIndia2 May 2022
1 vial, single-use in 1 carton / 3.5 mL in 1 vial, single-use72205-183-01Novadoz PharmaceuticalsIndia27 July 2022
1 vial, single-dose in 1 carton / 3.5 mL in 1 vial, single-dose83090-008-01Sintetica15 July 2023
1 vial in 1 carton / 3.5 mL in 1 vial70069-836-01Somerset Therapeutics29 April 2025
1 vial, single-use in 1 carton / 3.5 mL in 1 vial, single-use68001-541-36BluePoint Laboratories31 July 2022

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.

RegisterStatusSource
US FDAListed, marketedSource record for this pageChecked 12 November 2026
US FDAFirst approved 13 May 2003Drugs@FDA
EU (EMA)AuthorisedEMA medicines data
India (CDSCO)Not yet confirmed against CDSCO approval lists—
AustriaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
BelgiumRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
BulgariaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
CroatiaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
CyprusRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
CzechiaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
DenmarkRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
EstoniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
FinlandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
FranceRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
GermanyRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
GreeceRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
HungaryRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
IcelandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
IrelandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
ItalyRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LatviaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LiechtensteinRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LithuaniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LuxembourgRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
MaltaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
NetherlandsRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
NorwayRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
PolandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
PortugalRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
RomaniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SlovakiaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SloveniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SpainRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SwedenRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
United StatesRegisteredUS FDA (NDC directory, openFDA)Checked 12 November 2026

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

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 Bortezomib

For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.

Data sources

Need Bortezomib 3.5 mg/3.5 mL powder for injection for your hospital or patient?

Send one request with the destination country and quantity. We confirm availability, lead time and the documents your regulator needs.