Medicine
Octaplas 11.5 g/200 mL injection
Octaplas 11.5 g/200 mL injection is a prescription medicine containing Plasma protein fraction for intravenous use, marketed by Octapharma, 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 at ≤ -18°C (-0.4°F) for 3 years from the date of manufacture. Use thawed…
Key facts
- Active ingredient (INN)
- Plasma protein fraction
- Brand
- Octaplas
- Strength
- 11.5 g/200 mL
- Dosage form
- Injection
- Route
- Intravenous
- Packs
- 200 mL and 1 more
- Marketing authorisation holder
- Octapharma
- Manufacturer
- Octapharma
- Origin register
- US FDA, United States
- Storage
- Store at ≤ -18°C (-0.4°F) for 3 years from the date of manufacture. Use thawed product within 24 hr. if stored at 1 - 6°C (33.8°F to 42.8°F) or within 8 hr. if stored at 20 - 25°C (68°F to 77°F). Store protected from light.
- Cold chain
- Yes, shipped temperature controlled
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- HS code (indicative)
- 3002.12Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 18 July 2013
- Identifiers
- DailyMed set ID e629b5ce-f4e8-59d7-5000-cc874da27d2a, b4981410-de8e-8401-a720-f6df2561fbc1, 998415d8-9bbe-e5b8-c3b0-3ba0344faacb +1NDC 68982-955, 68982-953, 68982-952 +1Application BLA125416
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 |
|---|---|---|---|
| 200 mL in 1 bag | 68982-952-01 | Octapharma | 18 July 2013 |
| 200 mL in 1 bag | 68982-953-01 | Octapharma | 18 July 2013 |
| 200 mL in 1 bag | 68982-954-01 | Octapharma | 18 July 2013 |
| 200 mL in 1 bag | 68982-955-01 | Octapharma | 18 July 2013 |
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 |
| 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
Clinical summary
Plasma protein fraction is a prescription medicine. It is available as injection for intravenous use. MedsAcross supplies Plasma protein fraction 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 Plasma protein fractionFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Octaplas prescribing information (Octapharma) · U.S. National Library of Medicine, DailyMed
Need Octaplas 11.5 g/200 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.