Register entryShortage reported
Exela Pharma Sciences
- Registered sites
- 1
- Drug products
- 24
- Live patents
- 17
- Countries
- 1
- Base
- United States
Authorisation
Registered operations
What the FDA has registered these sites to do. This is the regulatory record, not a marketing claim.
Analytical testingActive ingredient (API) manufactureLabellingFinished drug manufacturePackagingsterilize
Sites
Facilities
1| Site | Location | Operations | FEI |
|---|---|---|---|
| Exela Pharma Sciences, LLC. | Lenoir, NCUnited States | Analytical testing, Active ingredient (API) manufacture, Labelling, Finished drug manufacture, Packaging, sterilize | 3008563008 |
Alert
Products in shortage
3| Drug | Presentation | Availability |
|---|---|---|
| Sodium Bicarbonate Injection | Sodium Bicarbonate, Injection, 84 mg/1 mL (NDC 51754-5001-5) | Available |
| Sodium Bicarbonate Injection | Sodium Bicarbonate, Injection, 84 mg/1 mL (NDC 51754-5011-4) | Available |
| Sodium Bicarbonate Injection | Sodium Bicarbonate, Injection, 42 mg/1 mL (NDC 51754-5012-4) | Available |
Exclusivity
Patents
17Unexpired Orange Book patents where this company is the application holder.
| Product | Active ingredient | Expiry |
|---|---|---|
| ELCYS | CYSTEINE HYDROCHLORIDE | Jan 2039 |
| GANZYK-RTU | GANCICLOVIR | Sept 2034 |
Catalogue
Marketed products
24Showing 24 of 24.
| Brand | Generic name | Form | Category |
|---|---|---|---|
| Akovaz | ephedrine sulfate | INJECTION | NDA |
| Akovaz | ephedrine sulfate | INJECTION | NDA |
| Bloxiverz | Neostigmine Methylsulfate | INJECTION | NDA |
| CUPRIC CHLORIDE | cupric chloride | INJECTION, SOLUTION | ANDA |
| ELCYS | Cysteine Hydrochloride | INJECTION, SOLUTION | NDA |
| ELCYS | Cysteine Hydrochloride | INJECTION, SOLUTION | NDA |
| GLYRX-PF | glycopyrrolate | INJECTION, SOLUTION | NDA |
| GLYRX-PF | glycopyrrolate | INJECTION, SOLUTION | NDA |
| GLYRX-PF | glycopyrrolate | INJECTION, SOLUTION | NDA |
| GLYRX-PF | glycopyrrolate | INJECTION, SOLUTION | NDA |
| NIPRIDE RTU | Sodium Nitroprusside | INJECTION, SOLUTION | NDA |
| NIPRIDE RTU | Sodium Nitroprusside | INJECTION, SOLUTION | NDA |
| Potassium Acetate | Potassium Acetate | INJECTION | ANDA |
| Sodium Bicarbonate | SODIUM BICARBONATE | INJECTION, SOLUTION | ANDA |
| Sodium Bicarbonate | SODIUM BICARBONATE | INJECTION, SOLUTION | ANDA |
| Sodium Bicarbonate | SODIUM BICARBONATE | INJECTION, SOLUTION | ANDA |
| Sodium Bicarbonate | SODIUM BICARBONATE | INJECTION, SOLUTION | ANDA |
| Sodium Bicarbonate | SODIUM BICARBONATE | INJECTION, SOLUTION | ANDA |
| TRANEXAMIC ACID IN SODIUM CHLORIDE | tranexamic acid | INJECTION, SOLUTION | NDA |
| Verapamil Hydrochloride | Verapamil Hydrochloride | INJECTION | NDA |
| Verapamil Hydrochloride | Verapamil Hydrochloride | INJECTION | NDA |
| Zinc Chloride | Zinc Chloride | INJECTION | ANDA |
| caffeine citrate | caffeine citrate | INJECTION | ANDA |
| caffeine citrate | CAFFEINE CITRATE | SOLUTION | ANDA |
Provenance
Facility and operations data from the FDA Drug Establishments Current Registration Site. Product data from the openFDA National Drug Code Directory. Patent and exclusivity data from the FDA Orange Book. Shortage data from the FDA drug shortage database. Contact details the FDA publishes for registered establishments are deliberately not reproduced here. This entry is compiled from public records and has not been claimed by the company.