Medicine
Glatopa 40 mg/1 mL injection
Glatopa 40 mg/1 mL injection is a prescription medicine containing Glatiramer for subcutaneous use, marketed by Sandoz, 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 Glatopa refrigerated at 2°C to 8°C (36°F to 46°F). Do not freeze…
Key facts
- Active ingredient (INN)
- Glatiramer
- Brand
- Glatopa
- Strength
- 40 mg/1 mL
- Dosage form
- Injection
- Route
- Subcutaneous
- Packs
- 12 blister pack of 1 mL
- Marketing authorisation holder
- Sandoz
- Manufacturers
- SandozBryant Ranch Prepack
- Origin register
- US FDA, United States
- Storage
- Store Glatopa refrigerated at 2°C to 8°C (36°F to 46°F). Do not freeze Glatopa. If a Glatopa syringe freezes, it should be discarded. If needed, the patient may store Glatopa 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
- 12 February 2018
- Identifiers
- RxCUI 1487361, 2000007, 1111641 +1DailyMed set ID 028fdf0e-2340-407b-bcd8-5a99accdddbf, 5f01e40a-b6f6-40fb-b37c-3d06f1428e86NDC 63629-8816, 0781-3250Application ANDA206921
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
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 12 blister pack in 1 carton / 1 syringe, glass in 1 blister pack / 1 mL in 1 syringe, glass | 0781-3250-89 | Sandoz | 12 February 2018 |
| 12 blister pack in 1 carton / 1 syringe, glass in 1 blister pack / 1 mL in 1 syringe, glass | 63629-8816-1 | Bryant Ranch Prepack | 10 September 2021 |
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 Glatopa 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.