Medicine
Pancreaze 61500 units/10500 units/35500 units delayed-release capsule
Pancreaze 61500 units/10500 units/35500 units delayed-release capsule is a prescription medicine containing Pancrelipase amylase, Pancrelipase lipase and Pancrelipase protease for oral use, marketed by Vivus, 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 PANCREAZE at room temperature between 15ºC and 25ºC (59°F to 77°F)…
Key facts
- Active ingredient (INN)
- Pancrelipase amylase, Pancrelipase lipase and Pancrelipase protease
- Brand
- Pancreaze
- Strength
- 61500 units/10500 units/35500 units
- Dosage form
- Delayed-release capsule
- Route
- Oral
- Packs
- 1 bottle
- Marketing authorisation holder
- Vivus
- Manufacturer
- Vivus
- Origin register
- US FDA, United States
- Storage
- Store PANCREAZE at room temperature between 15ºC and 25ºC (59°F to 77°F), excursion permitted up to 40ºC (104°F) for 24 hours. After opening, keep bottle tightly closed between uses to protect from moisture. Store and dispense PANCREAZE in the original container.
- 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
- 12 April 2010
- Identifiers
- RxCUI 1806919, 1806921, 1806924 +7DailyMed set ID e8f5d2fe-728d-42af-99a6-83dddc6539c5NDC 62541-403Application BLA022523
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 bottle, glass in 1 carton / 100 capsule, delayed release in 1 bottle, glass | 62541-403-10 | Vivus | 12 April 2010 |
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 Pancreaze 61500 units/10500 units/35500 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.