Medicine
Glatiramer 40 mg/1 mL injection
Glatiramer 40 mg/1 mL injection is a generic prescription medicine for subcutaneous use, made by 6 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. It ships in a temperature-controlled cold chain.
Availability
Export supply from India to licensed buyers
Typical lead time
On request
Counted from payment and complete documents
Shipping
Cold chain
Store Glatiramer Acetate Injection refrigerated at 2°C to 8°C (36°F to 46°F)…
Key facts
- Active ingredient (INN)
- Glatiramer
- Brand
- Sold under the generic name
- Strength
- 40 mg/1 mL
- Dosage form
- Injection
- Route
- Subcutaneous
- Packs
- 12 blister pack of 1 mL, 12 syringes of 1 mL and 3 more
- Manufacturers
- Sun Pharmaceutical IndustriesIndiaZydus LifesciencesIndiaAjenat PharmaceuticalsItalfarmacoMylan PharmaceuticalsUpsher-Smith Laboratories
- Origin register
- US FDA, United States
- Storage
- Store Glatiramer Acetate Injection refrigerated at 2°C to 8°C (36°F to 46°F). Do not freeze Glatiramer Acetate Injection. If a Glatiramer Acetate Injection syringe freezes, it should be discarded. If needed, the patient may store Glatiramer Acetate Injection at room temperature, 15°C to 30°C (59°F to 86°F), for up to one month, but refrigeration is preferred.
- Cold chain
- Yes, shipped temperature controlled
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 4 October 2017
- Identifiers
- RxCUI 1111641, 1487361DailyMed set ID 707a64ef-964e-44a3-8a0f-fcc2eb5b1af2, 1ec10223-880d-402f-a759-9cd179bf09de, dfacc3e2-5c91-41de-a377-873276a5cf67 +3NDC 0832-6085, 82983-430, 47335-991 +3Application ANDA214741, ANDA214022, ANDA206873 +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 |
|---|---|---|---|
| 12 blister pack in 1 carton / 1 syringe in 1 blister pack / 1 mL in 1 syringe | 47335-991-02 | Sun Pharmaceutical IndustriesIndia | 15 August 2025 |
| 12 blister pack in 1 carton / 1 syringe in 1 blister pack / 1 mL in 1 syringe | 70710-1549-6 | Zydus LifesciencesIndia | 10 November 2025 |
| 12 blister pack in 1 carton / 1 syringe in 1 blister pack / 1 mL in 1 syringe | 82983-430-12 | Ajenat Pharmaceuticals | 20 March 2026 |
| 12 syringe in 1 carton / 1 mL in 1 syringe | 11797-765-03 | Italfarmaco | 10 November 2025 |
| 12 blister pack in 1 carton / 1 syringe in 1 blister pack / 1 mL in 1 syringe | 0378-6961-12 | Mylan Pharmaceuticals | 4 October 2017 |
| 12 syringe, glass in 1 carton / 1 mL in 1 syringe, glass | 0832-6085-12 | Upsher-Smith Laboratories | 23 January 2026 |
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 20 December 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
Alternatives
Other makers and brands of Glatiramer 40 mg/1 mL injection.
Other strengths and forms of Glatiramer
Clinical summary
Glatiramer is a prescription medicine indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults. MedsAcross supplies Glatiramer 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 GlatiramerFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Copaxone prescribing information (Teva Neuroscience) · U.S. National Library of Medicine, DailyMed
Need Glatiramer 40 mg/1 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.