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Medicine

Paclitaxel 30 mg/5 mL injection

Paclitaxel · Intravenous
Available on requestPrescription onlyUS FDAGeneric name

Paclitaxel 30 mg/5 mL injection is a generic prescription medicine for intravenous use, made by 8 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

Store the vials in original cartons at 20° to 25°C (68° to 77°F). Retain in…

Key facts

Active ingredient (INN)
Paclitaxel
Brand
Sold under the generic name
Strength
30 mg/5 mL
Dosage form
Injection
Route
Intravenous
Packs
1 vial of 5 mL and 8 more
Manufacturers
Alembic PharmaceuticalsIndiaAvet PharmaceuticalsIndiaGland PharmaIndiaNatco PharmaIndiaNovadoz PharmaceuticalsIndiaHospiraTeva Parenteral MedicinesSagent Pharmaceuticals
Origin register
US FDA, United States
Storage
Store the vials in original cartons at 20° to 25°C (68° to 77°F). Retain in the original package to protect from light.
Cold chain
Not required on record
Prescription status
Prescription only
Controlled substance
Not recorded as controlled
ATC code
L01CD01 Paclitaxel
HS code (indicative)
3004.90Indicative only. Your customs broker confirms the final tariff code.
Marketing category
marketed
Marketed since
1 March 2004
Identifiers
RxCUI 312199DailyMed set ID e4be6cbf-72b9-4f7f-9b1b-459b2d35961a, b4c5d08a-e0f5-4af1-97d6-213705adedf1, 0c12c77c-5fd4-48dc-a318-e96892233992 +7NDC 0703-3213, 23155-882, 62332-620 +7Application ANDA075184, ANDA207326, ANDA216874 +3

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, multi-dose in 1 carton / 5 mL in 1 vial, multi-dose46708-620-05Alembic PharmaceuticalsIndia20 October 2022
1 vial, multi-dose in 1 carton / 5 mL in 1 vial, multi-dose62332-620-05Alembic PharmaceuticalsIndia20 October 2022
1 vial, multi-dose in 1 carton / 5 mL in 1 vial, multi-dose23155-882-31Avet PharmaceuticalsIndia31 August 2023
1 vial, multi-dose in 1 carton / 5 mL in 1 vial, multi-dose68083-178-01Gland PharmaIndia30 September 2016
1 vial, multi-dose in 1 carton / 5 mL in 1 vial, multi-dose69339-227-05Natco PharmaIndia7 November 2024
1 vial, multi-dose in 1 carton / 5 mL in 1 vial, multi-dose72205-061-01Novadoz PharmaceuticalsIndia26 August 2020
1 vial, multi-dose in 1 carton / 5 mL in 1 vial, multi-dose61703-015-04Hospira8 April 2025
1 vial, multi-dose in 1 carton / 5 mL in 1 vial, multi-dose61703-342-09Hospira1 March 2004
1 vial, multi-dose in 1 carton / 5 mL in 1 vial, multi-dose0703-3213-01Teva Parenteral Medicines7 July 2020
1 vial, multi-dose in 1 carton / 5 mL in 1 vial, multi-dose0703-3213-81Teva Parenteral Medicines7 July 2020
1 vial in 1 carton / 5 mL in 1 vial25021-255-05Sagent Pharmaceuticals1 February 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.

RegisterStatusSource
US FDAListed, marketedSource record for this pageChecked 12 November 2026
US FDAFirst approved 29 December 1992Drugs@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 Paclitaxel

Clinical summary

Paclitaxel is a microtubule inhibitor indicated for the treatment of metastatic breast cancer, after failure of combination chemotherapy for metastatic disease or relapse within 6 months of adjuvant chemotherapy, among other approved uses. MedsAcross supplies Paclitaxel 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 Paclitaxel

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

Data sources

Need Paclitaxel 30 mg/5 mL 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.