Medicine
Prolastin-C Liquid 4000 mg/80 mL injection
Prolastin-C Liquid 4000 mg/80 mL injection is a prescription medicine containing .alpha.1-proteinase inhibitor human for intravenous use, marketed by Grifols, 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 refrigerated at 2-8°C (36-46°F) for the period indicated by the…
Key facts
- Active ingredient (INN)
- .alpha.1-proteinase inhibitor human
- Brand
- Prolastin-C Liquid
- Strength
- 4000 mg/80 mL
- Dosage form
- Injection
- Route
- Intravenous
- Packs
- 1 vial of 80 mL
- Marketing authorisation holder
- Grifols
- Manufacturer
- Grifols
- Origin register
- US FDA, United States
- Storage
- Store refrigerated at 2-8°C (36-46°F) for the period indicated by the expiration date on its label. Do not freeze. Product may be stored at room temperatures not exceeding 25 • C (77 • F) for up to one month, after which the product must be used or immediately discarded.
- 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
- 2 December 1987
- Identifiers
- DailyMed set ID 2b620e6b-6a24-0957-1288-ae529c4cc3a2NDC 13533-705Application BLA103174
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 |
|---|---|---|---|
| 1 vial in 1 carton / 80 mL in 1 vial | 13533-705-51 | Grifols | 2 December 1987 |
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
Other strengths and forms of .alpha.1-proteinase inhibitor human
Clinical summary
.alpha.1-proteinase inhibitor human is a human alpha-1 proteinase inhibitor. It is available as injection and kits for intravenous use. MedsAcross supplies .alpha.1-proteinase inhibitor human 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 .alpha.1-proteinase inhibitor humanFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Prolastin-C Liquid prescribing information (Grifols) · U.S. National Library of Medicine, DailyMed
Need Prolastin-C Liquid 4000 mg/80 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.