Medicine
Zenpep 168000 units/40000 units/126000 units delayed-release capsule
Zenpep 168000 units/40000 units/126000 units delayed-release capsule is a prescription medicine containing Pancrelipase amylase, Pancrelipase lipase and Pancrelipase protease for oral use, marketed by Aimmune 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.
Availability
Export supply from India to licensed buyers
Typical lead time
On request
Counted from payment and complete documents
Shipping
Ambient
Store at room temperature, 20°C to 25°C (68°F to 77°F) and protect from…
Key facts
- Active ingredient (INN)
- Pancrelipase amylase, Pancrelipase lipase and Pancrelipase protease
- Brand
- Zenpep
- Strength
- 168000 units/40000 units/126000 units
- Dosage form
- Delayed-release capsule
- Route
- Oral
- Packs
- 100 capsules
- Marketing authorisation holder
- Aimmune Therapeutics
- Manufacturer
- Aimmune Therapeutics
- Origin register
- US FDA, United States
- Storage
- Store at room temperature, 20°C to 25°C (68°F to 77°F) and protect from moisture. Brief excursions permitted to 15°C to 40°C (59°F to104°F) for 24 hours. Store at up to 30°C (86°F) for up to 6 months and protect from moisture. Brief excursions permitted to 15°C to 40°C (59°F to 104°F) for up to 30 days. After opening, keep bottle tightly closed between uses to protect from moisture.
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- HS code (indicative)
- 3002.15Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 1 November 2020
- Identifiers
- RxCUI 1594671, 1594673, 1595290 +7DailyMed set ID 7f16f2d4-8df6-4bd7-ac10-56994fa257b0NDC 73562-114Application BLA022210
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 |
|---|---|---|---|
| 100 capsule, delayed release in 1 bottle | 73562-114-01 | Aimmune Therapeutics | 1 November 2020 |
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 Pancrelipase amylase, Pancrelipase lipase and Pancrelipase protease
Clinical summary
Pancrelipase amylase, Pancrelipase lipase and Pancrelipase protease is a fixed-dose combination medicine indicated for the treatment of exocrine pancreatic insufficiency in adult and pediatric patients. MedsAcross supplies Pancrelipase amylase, Pancrelipase lipase and Pancrelipase protease 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 Pancrelipase amylase, Pancrelipase lipase and Pancrelipase proteaseFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Zenpep prescribing information (Aimmune Therapeutics) · U.S. National Library of Medicine, DailyMed
Need Zenpep 168000 units/40000 units/126000 units delayed-release capsule 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.