Medicine
Pombiliti Atga 105 mg powder for injection
Pombiliti Atga 105 mg powder for injection is a prescription medicine containing Cipaglucosidase alfa for intravenous use, marketed by Amicus Therapeutics, 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℃ to 8℃ (36℉ to 46℉) in the original carton to protect…
Key facts
- Active ingredient (INN)
- Cipaglucosidase alfa
- Brand
- Pombiliti Atga
- Strength
- 105 mg
- Dosage form
- Powder for injection
- Route
- Intravenous
- Packs
- 1 vial, 10 vials, 25 vials
- Marketing authorisation holder
- Amicus Therapeutics
- Manufacturer
- Amicus Therapeutics
- Origin register
- US FDA, United States
- Storage
- Store refrigerated at 2℃ to 8℃ (36℉ to 46℉) in the original carton to protect from light. Do not freeze. For storage of the reconstituted solution and diluted solution.
- Cold chain
- Yes, shipped temperature controlled
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- A16AB Metabolic disease treatments, including enzyme replacement, subgroup A16A, subgroup A16AB
- HS code (indicative)
- 3002.15Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 11 October 2023
- Identifiers
- RxCUI 2667440, 2667446DailyMed set ID d77aa596-910d-516b-e053-2995a90a0839NDC 71904-200Application BLA761204
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, glass in 1 carton / 105 injection, powder, lyophilized, for solution in 1 vial, glass | 71904-200-01 | Amicus Therapeutics | 11 October 2023 |
| 10 vial, glass in 1 carton / 105 injection, powder, lyophilized, for solution in 1 vial, glass | 71904-200-02 | Amicus Therapeutics | 11 October 2023 |
| 25 vial, glass in 1 carton / 105 injection, powder, lyophilized, for solution in 1 vial, glass | 71904-200-03 | Amicus Therapeutics | 11 October 2023 |
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.
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
Cipaglucosidase alfa is a hydrolytic lysosomal glycogen-specific enzyme indicated , in combination with Opfolda, for the treatment of adult patients with late-onset Pompe disease (lysosomal acid alpha-glucosidase [GAA] deficiency) weighing ≥40 kg, among other approved uses. MedsAcross supplies Cipaglucosidase alfa 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 Cipaglucosidase alfaFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- POMBILITI ATGA prescribing information (Amicus Therapeutics) · U.S. National Library of Medicine, DailyMed
- Pombiliti: European public assessment report (EPAR) · European Medicines Agency
Need Pombiliti Atga 105 mg powder for 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.