Register entryShortage reported
Amphastar France Pharmaceuticals
Data as of · How to read this entry
- Registered sites
- 2
- Active NDC listings
- 23
- Labeller names
- 2
- Live patents
- 3
- Exclusivities
- 1
- Shortage listings
- 6
- Countries
- 2
- Base
- United States
Authorisation
Registered operations
Analytical testing2Active ingredient (API) manufacture1distribute1Labelling1Finished drug manufacture1Packaging1
Sites
Registered establishments
2| Establishment | Address | Registered for | FEI / DUNS |
|---|---|---|---|
| Amphastar France Pharmaceuticals | Usine Saint-Charles, Eragny-Sur-Epte, 60590, France (FRA) | Analytical testing, Active ingredient (API) manufacture | 3003672088266028318 |
| Amphastar Pharmaceuticals, Inc. | 11570 6th Street, Rancho Cucamonga, California (CA) 91730, United States (USA) | Analytical testing, distribute, Labelling, Finished drug manufacture, Packaging | 3002936358024736733 |
Alert
Drug shortage listings
6| Drug | Presentation | Status | Availability | Posted / updated |
|---|---|---|---|---|
| Atropine Sulfate InjectionAnesthesia, Neurology, Pediatric | Atropine Sulfate, Injection, .1 mg/1 mL (NDC 76329-3340-1) | Current | Available | 1 Jan 202016 Sept 2026 |
| Dextrose Monohydrate 50% InjectionEndocrinology/Metabolism, Gastroenterology, Pediatric | Dextrose Monohydrate 50%, Injection, 25 g/50 mL (NDC 76329-3302-1) | Current | Available | 13 Jan 202216 Sept 2026 |
| Lidocaine Hydrochloride InjectionAnesthesia, Pediatric | Lidocaine Hydrochloride, Injection, 20 mg/1 mL (NDC 76329-3390-1) | Current | Limited Availability | 22 Feb 201216 Sept 2026 |
| Lorazepam InjectionNeurology | Lorazepam, Injection, 2 mg/1 mL (NDC 76329-8261-1) | Current | Available | 3 May 201816 Sept 2026 |
| Morphine Sulfate InjectionAnalgesia/Addiction | Morphine Sulfate, Injection, 1 mg/1 mL (NDC 76329-1912-1) | Current | Available | 6 Dec 201816 Sept 2026 |
| Sodium Bicarbonate InjectionEndocrinology/Metabolism, Gastroenterology, Pediatric | Sodium Bicarbonate, Injection, 84 mg/1 mL (NDC 76329-3352-1) | Current | Limited Availability | 1 Mar 201716 Sept 2026 |
Catalogue
Drug listings by form and route
2323 active NDC listings: 22 human prescription drug, 1 bulk ingredient. By marketing category: ANDA 18, NDA 3, BLA 1, BULK INGREDIENT 1.
| Dosage form | NDCs |
|---|---|
| injection | 14 |
| powder | 3 |
| injection, solution | 2 |
| injection, suspension, extended release | 2 |
| injection, powder, lyophilized, for solution | 1 |
| kit | 1 |
| Route | NDCs |
|---|---|
| subcutaneous | 13 |
| intravenous | 7 |
| intramuscular | 5 |
| intracardiac | 2 |
| nasal | 2 |
| Labeller name on the listing | NDCs |
|---|---|
| amphastar pharmaceuticals, inc. | 22 |
| amphastar france pharmaceuticals | 1 |
Exclusivity
Patents and exclusivities
3| Patent | Product | Covers | Expiry |
|---|---|---|---|
| 10213487 | BAQSIMIglucagon | product | Feb 2036 |
| 12370241 | BAQSIMIglucagon | product | Feb 2036 |
| 10765602 | BAQSIMIglucagon | product | Sept 2039 |
| Product | Exclusivity | Until |
|---|---|---|
| BAQSIMIGLUCAGON | NPP New patient population | Mar 2028 |
Catalogue
Marketed products
23| Brand | Generic name | Form / route | NDC |
|---|---|---|---|
| AMPHADASE | hyaluronidase | injection, subcutaneous | 0548-9090BLA |
| Baqsimi | glucagon | powder, nasal | 0548-8351NDA |
| Baqsimi | glucagon | powder, nasal | 0548-8352NDA |
| Cortrosyn | Cosyntropin | injection, powder, lyophilized, for solution, intramuscular, intravenous | 0548-5900NDA |
| Enoxaparin Sodium | Enoxaparin sodium | injection, subcutaneous | 0548-5601ANDA |
| Enoxaparin Sodium | Enoxaparin sodium | injection, subcutaneous | 0548-5602ANDA |
| Enoxaparin Sodium | Enoxaparin sodium | injection, subcutaneous | 0548-5603ANDA |
| Enoxaparin Sodium | Enoxaparin sodium | injection, subcutaneous | 0548-5604ANDA |
| Enoxaparin Sodium | Enoxaparin sodium | injection, subcutaneous | 0548-5605ANDA |
| Enoxaparin Sodium | Enoxaparin sodium | injection, subcutaneous | 0548-5606ANDA |
| Enoxaparin Sodium | Enoxaparin sodium | injection, subcutaneous | 0548-5607ANDA |
| Enoxaparin Sodium | enoxaparin sodium | injection, intravenous, subcutaneous | 0548-5608ANDA |
| Ganirelix Acetate | Ganirelix Acetate | injection, subcutaneous | 0548-5001ANDA |
| Glucagon | Glucagon | kit | 0548-5850ANDA |
| ISOPROTERENOL HYDROCHLORIDE | Isoproterenol Hydrochloride | injection, solution, intracardiac, intramuscular, intravenous, subcutaneous | 0548-9501ANDA |
| ISOPROTERENOL HYDROCHLORIDE | Isoproterenol Hydrochloride | injection, solution, intracardiac, intramuscular, intravenous, subcutaneous | 0548-9502ANDA |
| Medroxyprogesterone Acetate | Medroxyprogesterone acetate | injection, suspension, extended release, intramuscular | 0548-5400ANDA |
| Medroxyprogesterone Acetate | Medroxyprogesterone acetate | injection, suspension, extended release, intramuscular | 0548-5701ANDA |
| NEOSTIGMINE METHYLSULFATE | neostigmine methylsulfate | injection, intravenous | 0548-9601ANDA |
| NEOSTIGMINE METHYLSULFATE | neostigmine methylsulfate | injection, intravenous | 0548-9602ANDA |
| - | Recombinant Human Insulin | powder | 69098-101BULK INGREDIENT |
| Teriparatide | Teriparatide | injection, subcutaneous | 0548-2311ANDA |
| Vasopressin | Vasopressin | injection, intravenous | 0548-9701ANDA |
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Enquiry
Common questions
- Is Amphastar France Pharmaceuticals FDA approved?
- Amphastar France Pharmaceuticals holds 2 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 Amphastar France Pharmaceuticals's drugs manufactured?
- At registered sites in France, the United States. The FDA register lists Eragny-Sur-Epte; Rancho Cucamonga, CA. Registered operations: analytical testing, active ingredient (API) manufacture, distribute, labelling, finished drug manufacture, packaging.
- What drugs does Amphastar France Pharmaceuticals make?
- 23 products are listed under Amphastar France Pharmaceuticals in the openFDA NDC Directory, most often as injection; powder; injection, solution. The full breakdown by dosage form and route is above. A listing count is not a sales figure.
- Are any Amphastar France Pharmaceuticals products in shortage?
- 6 presentations are currently listed in the FDA drug shortage database under Amphastar France Pharmaceuticals, covering Atropine Sulfate Injection, Dextrose Monohydrate 50% Injection, Lidocaine Hydrochloride Injection and 3 other drugs.
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.