Register entry
- Registered sites
- 1
- Active NDC listings
- 27
- Labeller names
- 2
- Live patents
- 0
- Countries
- 1
- Base
- United States
Authorisation
Registered operations
Analytical testing1Active ingredient (API) manufacture1Finished drug manufacture1
Sites
Registered establishments
1| Establishment | Address | Registered for | FEI / DUNS |
|---|---|---|---|
| Sigmapharm Laboratories, LLC | 3375 Progress Drive, Bensalem, Pennsylvania (PA) 19020, United States (USA) | Analytical testing, Active ingredient (API) manufacture, Finished drug manufacture | 3005444934556234636 |
Catalogue
Drug listings by form and route
2727 active NDC listings: 27 human prescription drug. By marketing category: ANDA 27.
| Dosage form | NDCs |
|---|---|
| tablet | 15 |
| capsule | 8 |
| tablet, film coated | 4 |
| Route | NDCs |
|---|---|
| oral | 25 |
| sublingual | 2 |
| Labeller name on the listing | NDCs |
|---|---|
| sigmapharm laboratories, llc | 21 |
| sigmapharm laboratories, llc | 6 |
Catalogue
Marketed products
27| Brand | Generic name | Form / route | NDC |
|---|---|---|---|
| ACITRETIN | ACITRETIN | capsule, oral | 42794-080ANDA |
| ACITRETIN | ACITRETIN | capsule, oral | 42794-081ANDA |
| ACITRETIN | ACITRETIN | capsule, oral | 42794-083ANDA |
| ADEFOVIR DIPIVOXIL | ADEFOVIR DIPIVOXIL | tablet, oral | 42794-003ANDA |
| AMBRISENTAN | AMBRISENTAN | tablet, film coated, oral | 42794-051ANDA |
| AMBRISENTAN | AMBRISENTAN | tablet, film coated, oral | 42794-052ANDA |
| ASENAPINE | ASENAPINE | tablet, sublingual | 42794-016ANDA |
| ASENAPINE | ASENAPINE | tablet, sublingual | 42794-017ANDA |
| Amiloride Hydrochloride | Amiloride Hydrochloride | tablet, oral | 42794-005ANDA |
| Disulfiram | Disulfiram | tablet, oral | 42794-028ANDA |
| Disulfiram | Disulfiram | tablet, oral | 42794-029ANDA |
| Dofetilide | Dofetilide | capsule, oral | 42794-044ANDA |
| Dofetilide | Dofetilide | capsule, oral | 42794-045ANDA |
| Dofetilide | Dofetilide | capsule, oral | 42794-046ANDA |
| Flucytosine | Flucytosine | capsule, oral | 42794-009ANDA |
| Flucytosine | Flucytosine | capsule, oral | 42794-010ANDA |
| Griseofulvin | Griseofulvin | tablet, oral | 42794-012ANDA |
| Liomny | Liothyronine Sodium | tablet, oral | 42794-131ANDA |
| Liomny | Liothyronine Sodium | tablet, oral | 42794-132ANDA |
| Liomny | Liothyronine Sodium | tablet, oral | 42794-133ANDA |
| Liothyronine Sodium | Liothyronine Sodium | tablet, oral | 42794-018ANDA |
| Liothyronine Sodium | Liothyronine Sodium | tablet, oral | 42794-019ANDA |
| Liothyronine Sodium | Liothyronine Sodium | tablet, oral | 42794-020ANDA |
| Protriptyline Hydrochloride | Protriptyline Hydrochloride | tablet, film coated, oral | 42794-004ANDA |
| Protriptyline Hydrochloride | Protriptyline Hydrochloride | tablet, film coated, oral | 42794-007ANDA |
| Ultramicrosize Griseofulvin | Ultramicrosize Griseofulvin | tablet, oral | 42794-013ANDA |
| Ultramicrosize Griseofulvin | Ultramicrosize Griseofulvin | tablet, oral | 42794-014ANDA |
Neighbours
Registered in the same town
1- AstraZeneca PLCBensalem, PA
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Enquiry
Common questions
- Is Sigmapharm Laboratories, LLC FDA approved?
- Sigmapharm Laboratories, 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 Sigmapharm Laboratories, LLC's drugs manufactured?
- The FDA register lists Bensalem, PA. Registered operations: analytical testing, active ingredient (API) manufacture, finished drug manufacture.
- What drugs does Sigmapharm Laboratories, LLC make?
- 27 products are listed under Sigmapharm Laboratories, LLC in the openFDA NDC Directory, most often as tablet; capsule; tablet, film coated. 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.