Register entry
- Registered sites
- 4
- Active NDC listings
- 41
- Labeller names
- 3
- Live patents
- 0
- Countries
- 2
- Base
- United States
Authorisation
Registered operations
Analytical testing3Active ingredient (API) manufacture2Finished drug manufacture1Repackaging1
Sites
Registered establishments
4| Establishment | Address | Registered for | FEI / DUNS |
|---|---|---|---|
| Pacific Medical Industries Ltd | #209,210,211 Kannar Street Dagon Seik Kan Township, Yangon, Yangon 11431, Burma (MMR) | Finished drug manufacture, Repackaging | 3013492630659604370 |
| AMPAC Fine Chemicals LLCRegistrant: American Pacific Corporation | 1100 Windfield Way, El Dorado Hills, California (CA) 95762, United States (USA) | Analytical testing | 3013339335841185296 |
| AMPAC Fine Chemicals Texas LLCRegistrant: American Pacific Corporation | 914 S 16 st, La Porte, Texas (TX) 77571, United States (USA) | Analytical testing, Active ingredient (API) manufacture | 3012318942949942416 |
| AMPAC Fine Chemicals LLCRegistrant: American Pacific Corporation | HIGHWAY 50 AND HAZEL AVENUE, RANCHO CORDOVA, California (CA) 95670, United States (USA) | Analytical testing, Active ingredient (API) manufacture | 2918710073903937 |
Catalogue
Drug listings by form and route
4141 active NDC listings: 32 bulk ingredient, 9 human prescription drug. By marketing category: BULK INGREDIENT 31, NDA AUTHORIZED GENERIC 7, ANDA 2, BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING 1.
| Dosage form | NDCs |
|---|---|
| powder | 32 |
| solution/ drops | 6 |
| gel | 1 |
| suspension | 1 |
| suspension/ drops | 1 |
| Route | NDCs |
|---|---|
| ophthalmic | 7 |
| oral | 1 |
| topical | 1 |
| Labeller name on the listing | NDCs |
|---|---|
| american pacific corporation | 28 |
| pacific pharma, inc. | 9 |
| american pacific corporation | 4 |
Catalogue
Marketed products
41| Brand | Generic name | Form / route | NDC |
|---|---|---|---|
| - | APD334 L-Arginine | powder | 50683-0534BULK INGREDIENT |
| - | Acalabrutinib Maleate | powder | 50683-0611BULK INGREDIENT |
| - | BUSULFAN | powder | 50683-0363BULK INGREDIENT |
| - | Brigatinib | powder | 50683-0420BULK INGREDIENT |
| Brimonidine tartrate | brimonidine tartrate | solution/ drops, ophthalmic | 82182-321NDA AUTHORIZED GENERIC |
| Brimonidine tartrate | brimonidine tartrate | solution/ drops, ophthalmic | 82182-773NDA AUTHORIZED GENERIC |
| - | CARMUSTINE | powder | 50683-0017BULK INGREDIENT |
| - | CHLORAMBUCIL | powder | 50683-0384BULK INGREDIENT |
| - | Crystalline RTA 408 | powder | 50683-0525BULK INGREDIENT |
| - | Cyclophosphamide Monohydrate | powder | 50683-0468BULK INGREDIENT |
| DAPSONE | dapsone | gel, topical | 60758-670NDA AUTHORIZED GENERIC |
| - | Etrasimod L-Arginine | powder | 50683-0677BULK INGREDIENT |
| FLUOROMETHOLONE | fluorometholone | solution/ drops, ophthalmic | 60758-880NDA AUTHORIZED GENERIC |
| - | Finerenone | powder | 50683-0540BULK INGREDIENT |
| KETOROLAC TROMETHAMINE | Ketorolac Tromethamine | solution/ drops, ophthalmic | 60758-773NDA AUTHORIZED GENERIC |
| - | LDF 3A | powder | 50683-0660BULK INGREDIENT |
| - | LEVETIRACETAM | powder | 50683-0322BULK INGREDIENT |
| - | LOXO-292 | powder | 50683-0547BULK INGREDIENT |
| - | Labetalol Hydrochloride | powder | 50683-0590BULK INGREDIENT |
| - | Levorphanol Tartrate | powder | 50683-0514BULK INGREDIENT |
| - | Melphalan | powder | 50683-0385BULK INGREDIENT |
| - | Melphalan, sieved | powder | 50683-0520BULK INGREDIENT |
| - | Molnupiravir | powder | 50683-0596BULK INGREDIENT |
| - | Oseltamivir Phosphate | powder | 50683-0557BULK INGREDIENT |
| PREDNISOLONE ACETATE | prednisolone acetate | suspension/ drops, ophthalmic | 60758-119NDA AUTHORIZED GENERIC |
| - | RUXOLITINIB PHOSPHATE | powder | 50683-0340BULK INGREDIENT |
| - | RUXOLITINIB PHOSPHATE | powder | 50683-0440BULK INGREDIENT |
| - | Remifentanil Hydrochloride | powder | 50683-0550BULK INGREDIENT |
| - | Ruxolitinib phosphate | powder | 50683-0597BULK INGREDIENT |
| - | Sofosbuvir | powder | 50683-0412BULK INGREDIENT |
| - | Sotorasib | powder | 50683-0573BULK INGREDIENT |
| Sucralfate | Sucralfate | suspension, oral | 82182-106NDA AUTHORIZED GENERIC |
| - | TEMOZOLOMIDE | powder | 50683-0185BULK INGREDIENT |
| - | TEMOZOLOMIDE | powder | 50683-0485BULK INGREDIENT |
| - | TENOFOVIR DISOPROXIL FUMARATE | powder | 50683-0289BULK INGREDIENT |
| - | THIOGUANINE | powder | 50683-0356BULK INGREDIENT |
| TIMOLOL MALEATE | timolol maleate | solution/ drops, ophthalmic | 60758-801ANDA |
| TIMOLOL MALEATE | timolol maleate | solution/ drops, ophthalmic | 60758-802ANDA |
| - | Thiotepa | powder | 50683-0465BULK INGREDIENT |
| - | Vibegron | powder | 50683-0536BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING |
| - | dex-Methylphenidate Hydrochloride | powder | 50683-0428BULK INGREDIENT |
Compare
Comparable companies in United States
- Hikma Pharmaceuticals USA Inc.4 sites · 763 NDC
- Church & Dwight Co., Inc.4 sites · 157 NDC
- Sterling Pharmaceutical Services, LLC4 sites · 104 NDC
- Bausch & Lomb Ireland Limited4 sites · 92 NDC
- Grifols Therapeutics LLC4 sites · 53 NDC
- Gilead Sciences, Inc.4 sites · 51 NDC
- Nice-Pak Products, LLC4 sites · 48 NDC
- HOVIONE FARMACIENCIA, S.A.4 sites · 47 NDC
- United Therapeutics Corporation4 sites · 40 NDC
- Avantor Performance Materials, LLC4 sites · 33 NDC
Enquiry
Common questions
- Is Pacific Medical Industries Ltd FDA approved?
- Pacific Medical Industries Ltd holds 4 FDA-registered establishments across 2 countries. 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 Pacific Medical Industries Ltd's drugs manufactured?
- At registered sites in MMR, the United States. The FDA register lists Yangon; El Dorado Hills, CA; La Porte, TX; RANCHO CORDOVA, CA. Registered operations: analytical testing, active ingredient (API) manufacture, finished drug manufacture, repackaging.
- What drugs does Pacific Medical Industries Ltd make?
- 41 products are listed under Pacific Medical Industries Ltd in the openFDA NDC Directory, most often as powder; solution/ drops; gel. 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.