Register entry
Aimmune Therapeutics Manufacturing, LLC
Data as of · How to read this entry
- Registered sites
- 1
- Active NDC listings
- 11
- Live patents
- 0
- Countries
- 1
- Base
- United States
Sites
Registered establishments
1| Establishment | Address | Registered for | FEI / DUNS |
|---|---|---|---|
| Aimmune Therapeutics Manufacturing, LLC | 9 4th Ave, Waltham, Massachusetts (MA) 02451-7506, United States (USA) | Analytical testing | 3021578714119050472 |
Catalogue
Drug listings by form and route
1111 active NDC listings: 11 human prescription drug. By marketing category: BLA 11.
| Dosage form | NDCs |
|---|---|
| capsule, delayed release | 8 |
| tablet | 2 |
| capsule | 1 |
| Route | NDCs |
|---|---|
| oral | 11 |
| Labeller name on the listing | NDCs |
|---|---|
| aimmune therapeutics, inc. | 11 |
Catalogue
Marketed products
11| Brand | Generic name | Form / route | NDC |
|---|---|---|---|
| VOWST | fecal microbiota spores, live-brpk | capsule, oral | 71881-400BLA |
| Viokace | Pancrelipase | tablet, oral | 73562-104BLA |
| Viokace | Pancrelipase | tablet, oral | 73562-208BLA |
| Zenpep | pancrelipase lipase, pancrelipase protease, pancrelipase amylase | capsule, delayed release, oral | 73562-110BLA |
| Zenpep | pancrelipase lipase, pancrelipase protease, pancrelipase amylase | capsule, delayed release, oral | 73562-111BLA |
| Zenpep | pancrelipase lipase, pancrelipase protease, pancrelipase amylase | capsule, delayed release, oral | 73562-112BLA |
| Zenpep | pancrelipase lipase, pancrelipase protease, pancrelipase amylase | capsule, delayed release, oral | 73562-113BLA |
| Zenpep | pancrelipase lipase, pancrelipase protease, pancrelipase amylase | capsule, delayed release, oral | 73562-114BLA |
| Zenpep | pancrelipase lipase, pancrelipase protease, pancrelipase amylase | capsule, delayed release, oral | 73562-115BLA |
| Zenpep | pancrelipase lipase, pancrelipase protease, pancrelipase amylase | capsule, delayed release, oral | 73562-116BLA |
| Zenpep | pancrelipase lipase, pancrelipase protease, pancrelipase amylase | capsule, delayed release, oral | 73562-117BLA |
Neighbours
Registered in the same town
1- Thea Pharma, Inc.Waltham, MA
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Enquiry
Common questions
- Is Aimmune Therapeutics Manufacturing, LLC FDA approved?
- Aimmune Therapeutics Manufacturing, LLC holds 1 FDA-registered establishment in the United States. Registration puts a site on the FDA's register and open to inspection; it is not an approval of the company. Approvals attach to individual drug applications.
- Where are Aimmune Therapeutics Manufacturing, LLC's registered sites?
- The FDA register lists Waltham, MA. Registered operations: analytical testing.
- What drugs does Aimmune Therapeutics Manufacturing, LLC make?
- 11 products are listed under Aimmune Therapeutics Manufacturing, LLC in the openFDA NDC Directory, most often as capsule, delayed release; tablet; capsule. The full breakdown by dosage form and route is above. A listing count is not a sales figure.
Compiled from FDA establishment registrations, the openFDA NDC Directory, the Orange Book and the FDA drug shortage database. Not claimed by the company. Sources and methodology.