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Sebelipase alfa is a medicine. It is available for export supply from India to licensed hospitals, importers and physicians, with the documents the destination country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
Key facts
- ATC classification
- A16AB14 Sebelipase alfa · Metabolic disease treatments, including enzyme replacement, subgroup A16A, subgroup A16AB
- US FDA first approval
- 8 December 2015
- EU status
- Authorised
- Orphan designation
- Yes
- WHO essential medicine
- Not recorded
- India (CDSCO)
- Not yet confirmed against CDSCO approval lists
- Identifiers
- UNII K4YTU42T8GRxCUI 1726975CAS 1276027-63-4DrugBank DB11563Q21789862
All presentations
No presentations of Sebelipase alfa are listed yet. Ask us to source it
Regulatory status
Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.
Questions and answers
Is Sebelipase alfa available for export from India?
No presentation of Sebelipase alfa is listed yet, but our sourcing team can check licensed channels. Send a request with the strength, quantity and destination country.
Is Sebelipase alfa approved by the US FDA?
Yes. The US FDA first approved Sebelipase alfa on 8 December 2015, according to Drugs@FDA.
Is Sebelipase alfa authorised in the European Union?
Yes. Sebelipase alfa has a central EU marketing authorisation (status: authorised), according to European Medicines Agency data.
Does Sebelipase alfa need cold chain shipping?
No listed presentation of Sebelipase alfa is recorded as needing a cold chain. Storage conditions are shown on each presentation page.
Which ATC class is Sebelipase alfa in?
Sebelipase alfa is classified under ATC code A16AB14 (Sebelipase alfa).
References
- Kanuma: European public assessment report (EPAR). European Medicines Agency. Retrieved 24 March 2026
Request Sebelipase alfa for export supply
Tell us the strength, quantity and destination country. Our team replies with availability, lead time and the import documents needed.