Register entryShortage reported
- Registered sites
- 1
- Active NDC listings
- 41
- Labeller names
- 4
- Live patents
- 0
- Shortage listings
- 4
- Countries
- 1
- Base
- United States
Authorisation
Registered operations
Analytical testing1Active ingredient (API) manufacture1Labelling1Finished drug manufacture1Packaging1
Sites
Registered establishments
1| Establishment | Address | Registered for | FEI / DUNS |
|---|---|---|---|
| Piramal Critical Care Inc | 3950 Schelden Circle, Bethlehem, Pennsylvania (PA) 18017, United States (USA) | Analytical testing, Active ingredient (API) manufacture, Labelling, Finished drug manufacture, Packaging | 1000135935805600439 |
Alert
Drug shortage listings
4| Drug | Presentation | Status | Availability | Posted / updated |
|---|---|---|---|---|
| Morphine Sulfate InjectionAnalgesia/Addiction | Mitigo, Injection, 200 mg/20 mL (NDC 66794-160-02) | Current | Available | 31 Oct 201715 Sept 2026 |
| Morphine Sulfate InjectionAnalgesia/Addiction | Mitigo, Injection, 500 mg/20 mL (NDC 66794-162-02) | Current | Available | 31 Oct 201715 Sept 2026 |
| Rocuronium Bromide InjectionAnesthesia | Rocuronium Bromide, Injection, 50 mg/5 mL (NDC 66794-228-41) | Current | Available | 15 Feb 202315 Sept 2026 |
| Rocuronium Bromide InjectionAnesthesia | Rocuronium Bromide, Injection, 100 mg/10 mL (NDC 66794-229-41) | Current | Limited Availability | 15 Feb 202315 Sept 2026 |
Catalogue
Drug listings by form and route
4141 active NDC listings: 40 human prescription drug, 1 bulk ingredient. By marketing category: ANDA 33, NDA 4, UNAPPROVED DRUG OTHER 3, BULK INGREDIENT 1.
| Dosage form | NDCs |
|---|---|
| injection, solution | 20 |
| injection | 9 |
| liquid | 9 |
| injection, powder, for solution | 2 |
| injection, powder, lyophilized, for solution | 1 |
| Route | NDCs |
|---|---|
| intravenous | 24 |
| respiratory (inhalation) | 8 |
| intramuscular | 7 |
| intrathecal | 6 |
| epidural | 2 |
| Labeller name on the listing | NDCs |
|---|---|
| piramal critical care inc | 23 |
| piramal critical care inc. | 10 |
| piramal critical care, inc. | 7 |
| piramal critical care | 1 |
Catalogue
Marketed products
41| Brand | Generic name | Form / route | NDC |
|---|---|---|---|
| Chlorpromazine hydrochloride | Chlorpromazine hydrochloride | injection, intramuscular | 66794-249ANDA |
| Chlorpromazine hydrochloride | Chlorpromazine hydrochloride | injection, intramuscular | 66794-250ANDA |
| DOXYCYCLINE | DOXYCYCLINE | injection, powder, lyophilized, for solution, intravenous | 66794-237ANDA |
| Desflurane | Desflurane | liquid, respiratory (inhalation) | 66794-021UNAPPROVED DRUG OTHER |
| Dexmedetomidine | Dexmedetomidine | injection, solution, intravenous | 66794-230ANDA |
| Dexmedetomidine | Dexmedetomidine | injection, solution, intravenous | 66794-233ANDA |
| Dexmedetomidine Hydrochloride | Dexmedetomidine Hydrochloride | injection, intravenous | 66794-234ANDA |
| Dexmedetomidine Hydrochloride | Dexmedetomidine Hydrochloride | injection, intravenous | 66794-235ANDA |
| Edaravone | Edaravone | injection, solution, intravenous | 66794-259ANDA |
| Erythromycin Lactobionate | Erythromycin Lactobionate | injection, powder, for solution, intravenous | 66794-251ANDA |
| Gablofen | Baclofen Injection | injection, solution, intrathecal | 66794-151NDA |
| Gablofen | Baclofen Injection | injection, solution, intrathecal | 66794-155NDA |
| Gablofen | Baclofen Injection | injection, solution, intrathecal | 66794-156NDA |
| Gablofen | Baclofen Injection | injection, solution, intrathecal | 66794-157NDA |
| Glycopyrrolate | Glycopyrrolate | injection, solution, intramuscular, intravenous | 66794-202ANDA |
| Glycopyrrolate | Glycopyrrolate | injection, solution, intramuscular, intravenous | 66794-203ANDA |
| Glycopyrrolate | Glycopyrrolate | injection, solution, intramuscular, intravenous | 66794-204ANDA |
| Glycopyrrolate | Glycopyrrolate | injection, solution, intramuscular, intravenous | 66794-205ANDA |
| Isoflurane | Isoflurane | liquid, respiratory (inhalation) | 66794-017ANDA |
| Isoflurane | Isoflurane | liquid, respiratory (inhalation) | 66794-020ANDA |
| Levothyroxine Sodium | Levothyroxine Sodium | injection, intravenous | 66794-200ANDA |
| Levothyroxine Sodium | Levothyroxine Sodium | injection, intravenous | 66794-201ANDA |
| Linezolid | Linezolid | injection, solution, intravenous | 66794-219ANDA |
| Linezolid | Linezolid | injection, intravenous | 66794-236ANDA |
| MITIGO | Morphine Sulfate | injection, epidural, intrathecal | 66794-160ANDA |
| MITIGO | Morphine Sulfate | injection, epidural, intrathecal | 66794-162ANDA |
| PANTOPRAZOLE SODIUM I.V. | PANTOPRAZOLE SODIUM | injection, powder, for solution, intravenous | 66794-258ANDA |
| Rocuronium | Rocuronium | injection, solution, intravenous | 66794-228ANDA |
| Rocuronium | Rocuronium | injection, solution, intravenous | 66794-229ANDA |
| Sevoflurane | Sevoflurane | liquid, respiratory (inhalation) | 66794-015ANDA |
| Sevoflurane | Sevoflurane | liquid, respiratory (inhalation) | 66794-022ANDA |
| - | Sevoflurane | liquid | 66794-023BULK INGREDIENT |
| Sojourn | Sevoflurane | liquid, respiratory (inhalation) | 66794-012ANDA |
| Succinylcholine Chloride | Succinylcholine Chloride | injection, solution, intramuscular, intravenous | 66794-232ANDA |
| Sugammadex | sugammadex | injection, solution, intravenous | 66794-256UNAPPROVED DRUG OTHER |
| Sugammadex | sugammadex | injection, solution, intravenous | 66794-257UNAPPROVED DRUG OTHER |
| Terrell | Isoflurane | liquid, respiratory (inhalation) | 66794-011ANDA |
| Terrell | Isoflurane | liquid, respiratory (inhalation) | 66794-019ANDA |
| Zinc Sulfate | Zinc Sulfate | injection, solution, intravenous | 66794-239ANDA |
| Zinc Sulfate | Zinc Sulfate | injection, solution, intravenous | 66794-240ANDA |
| Zinc Sulfate | Zinc Sulfate | injection, solution, intravenous | 66794-255ANDA |
Neighbours
Registered in the same town
3- Particle Technology Group, LLCBethlehem, PA
- Spray-Tek, Inc.Bethlehem, PA
- Digestive Care Inc.Bethlehem, PA
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Enquiry
Common questions
- Is Piramal Critical Care Inc FDA approved?
- Piramal Critical Care Inc 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 Piramal Critical Care Inc's drugs manufactured?
- The FDA register lists Bethlehem, PA. Registered operations: analytical testing, active ingredient (API) manufacture, labelling, finished drug manufacture, packaging.
- What drugs does Piramal Critical Care Inc make?
- 41 products are listed under Piramal Critical Care Inc in the openFDA NDC Directory, most often as injection, solution; injection; liquid. The full breakdown by dosage form and route is above. A listing count is not a sales figure.
- Are any Piramal Critical Care Inc products in shortage?
- 4 presentations are currently listed in the FDA drug shortage database under Piramal Critical Care Inc, covering Morphine Sulfate Injection, Rocuronium Bromide Injection.
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.