Medicine
Zemaira kit
Zemaira kit is a prescription medicine containing .alpha.1-proteinase inhibitor human, marketed by CSL Behring, 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
Avoid freezing, which may damage the diluent vial. When stored up to 25°C…
Key facts
- Active ingredient (INN)
- .alpha.1-proteinase inhibitor human
- Brand
- Zemaira
- Dosage form
- Kit
- Packs
- 1 kit
- Marketing authorisation holder
- CSL Behring
- Manufacturer
- CSL Behring
- Origin register
- US FDA, United States
- Storage
- Avoid freezing, which may damage the diluent vial. When stored up to 25°C (77°F), ZEMAIRA is stable for the period indicated by the expiration date on its vial label and carton.
- Cold chain
- Not required on record
- 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
- 24 April 2019
- Identifiers
- RxCUI 991722, 1661208DailyMed set ID 0c3354b5-a1d8-4f98-ad55-2eafe4265c4eNDC 0053-7203, 0053-7202Application BLA125078
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 kit in 1 carton * 76 mL in 1 vial, single-use * 76 mL in 1 vial, single-use | 0053-7202-02 | CSL Behring | 24 April 2019 |
| 1 kit in 1 carton * 95 mL in 1 vial, single-use * 95 mL in 1 vial, single-use | 0053-7203-02 | CSL Behring | 24 April 2019 |
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 Zemaira kit 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.