Medicine
Gemcitabine 1 g/25 mL powder for injection
Gemcitabine 1 g/25 mL powder for injection is a generic prescription medicine for intravenous 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
Export supply from India to licensed buyers
Typical lead time
On request
Counted from payment and complete documents
Shipping
Ambient
Store at controlled room temperature 20°C to 25°C (68°F to 77°F), excursions…
Key facts
- Active ingredient (INN)
- Gemcitabine
- Brand
- Sold under the generic name
- Strength
- 1 g/25 mL
- Dosage form
- Powder for injection
- Route
- Intravenous
- Packs
- 1 vial, 10 vials and 11 more
- Manufacturers
- Dr. Reddy's LaboratoriesIndiaGland PharmaIndiaTeyro LabsIndiaFresenius KabiSagent Pharmaceuticals
- Origin register
- US FDA, United States
- Storage
- Store at controlled room temperature 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C and 30°C (59°F and 86°F).
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- L01BC05 Gemcitabine
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 25 July 2011
- Identifiers
- RxCUI 1719000, 1719003, 1719005DailyMed set ID a6ddaa2f-4c17-430f-a7cd-96b6662923f6, c550dd16-a5e8-44be-87f2-210c15bbb513, eafcebc8-ddef-bb6b-fd0a-9d8b9962cdc4 +3NDC 82511-009, 63323-126, 55111-686 +8Application ANDA078759, ANDA090799, ANDA091365 +2
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-use in 1 carton / 5 mL in 1 vial, single-use | 55111-686-07 | Dr. Reddy's LaboratoriesIndia | 25 July 2011 |
| 1 vial, single-use in 1 carton / 25 mL in 1 vial, single-use | 55111-687-25 | Dr. Reddy's LaboratoriesIndia | 25 July 2011 |
| 1 vial in 1 carton / 5 mL in 1 vial | 68083-148-01 | Gland PharmaIndia | 1 February 2016 |
| 1 vial in 1 carton / 25 mL in 1 vial | 68083-149-01 | Gland PharmaIndia | 1 February 2016 |
| 1 vial, single-use in 1 carton / 5 mL in 1 vial, single-use | 82511-008-20 | Teyro LabsIndia | 8 August 2024 |
| 1 vial, single-use in 1 carton / 25 mL in 1 vial, single-use | 82511-009-10 | Teyro LabsIndia | 8 August 2024 |
| 1 vial, single-dose in 1 box / 5 mL in 1 vial, single-dose | 63323-102-13 | Fresenius Kabi | 26 July 2011 |
| 1 vial, single-dose in 1 box / 5 mL in 1 vial, single-dose | 63323-102-94 | Fresenius Kabi | 26 July 2011 |
| 1 vial, single-dose in 1 box / 25 mL in 1 vial, single-dose | 63323-125-53 | Fresenius Kabi | 26 July 2011 |
| 1 vial, single-dose in 1 box / 25 mL in 1 vial, single-dose | 63323-125-94 | Fresenius Kabi | 26 July 2011 |
| 1 vial, single-dose in 1 box / 50 mL in 1 vial, single-dose | 63323-126-03 | Fresenius Kabi | 26 July 2011 |
| 1 vial in 1 carton / 5 mL in 1 vial | 25021-234-10 | Sagent Pharmaceuticals | 29 December 2014 |
| 1 vial in 1 carton / 25 mL in 1 vial | 25021-235-50 | Sagent Pharmaceuticals | 29 December 2014 |
| 10 vial in 1 carton / 25 mL in 1 vial | 25021-235-51 | Sagent Pharmaceuticals | 15 December 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.
| Register | Status | Source |
|---|---|---|
| US FDA | Listed, marketed | Source record for this pageChecked 12 November 2026 |
| US FDA | First approved 15 May 1996 | Drugs@FDA |
| EU (EMA) | Not recorded | — |
| India (CDSCO) | Not yet confirmed against CDSCO approval lists | — |
| United States | Registered | US 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 Gemcitabine
Clinical summary
Gemcitabine is a nucleoside metabolic inhibitor indicated in combination with carboplatin, for the treatment of advanced ovarian cancer that has relapsed at least 6 months after completion of platinum-based therapy, among other approved uses. MedsAcross supplies Gemcitabine 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 GemcitabineFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Gemcitabine prescribing information (Hospira) · U.S. National Library of Medicine, DailyMed
Need Gemcitabine 1 g/25 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.