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STERISCIENCE SP Z O O

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Registered sites
1
Active NDC listings
16
Labeller names
2
Live patents
2
Countries
1
Base
Poland
Authorisation

Registered operations

Analytical testing1Labelling1Finished drug manufacture1Packaging1sterilize1
Sites

Registered establishments

1
EstablishmentAddressRegistered forFEI / DUNS
STERISCIENCE SP Z O OUl Daniszewska 10, Warszawa, Mazowieckie 03-230, Poland (POL)Analytical testing, Labelling, Finished drug manufacture, Packaging, sterilize3009685660522218056
Catalogue

Drug listings by form and route

16

16 active NDC listings: 16 human prescription drug. By marketing category: ANDA 15, NDA 1.

Dosage formNDCs
injection, solution8
injection, powder, lyophilized, for solution5
solution2
injection1
RouteNDCs
intravenous15
intramuscular5
Labeller name on the listingNDCs
steriscience specialties private limited8
steriscience specialties private limited8
Exclusivity

Patents and exclusivities

2
PatentProductCoversExpiry
11065265FOCINVEZfosaprepitant dimeglumineproductJan 2039
12042504FOCINVEZfosaprepitant dimeglumineproductJan 2039
Catalogue

Marketed products

16
BrandGeneric nameForm / routeNDC
DoxycyclineDoxycyclineinjection, powder, lyophilized, for solution, intravenous82449-008ANDA
FOCINVEZFOSAPREPITANT DIMEGLUMINEinjection, intravenous82449-231NDA
Methylene blueMethylene Blueinjection, solution, intravenous82449-002ANDA
Methylene blueMethylene Blueinjection, solution, intravenous82449-003ANDA
Midazolammidazolam hydrochlorideinjection, solution, intramuscular, intravenous82449-207ANDA
Midazolammidazolam hydrochlorideinjection, solution, intramuscular, intravenous82449-208ANDA
Midazolammidazolam hydrochlorideinjection, solution, intramuscular, intravenous82449-209ANDA
Rocuronium BromideRocuronium Bromideinjection, solution, intravenous82449-001ANDA
SUGAMMADEX SODIUMSUGAMMADEX SODIUMsolution, intravenous82449-241ANDA
SUGAMMADEX SODIUMSUGAMMADEX SODIUMsolution, intravenous82449-242ANDA
Sodium BicarbonateSODIUM BICARBONATEinjection, solution, intravenous82449-000ANDA
Succinylcholine ChlorideSuccinylcholine Chlorideinjection, solution, intramuscular, intravenous82449-232ANDA
Vancomycin HydrochlorideVancomycin Hydrochlorideinjection, powder, lyophilized, for solution, intravenous82449-005ANDA
Vancomycin HydrochlorideVancomycin Hydrochlorideinjection, powder, lyophilized, for solution, intravenous82449-006ANDA
Vancomycin HydrochlorideVancomycin Hydrochlorideinjection, powder, lyophilized, for solution, intravenous82449-007ANDA
Ziprasidone Mesylateziprasidone mesylateinjection, powder, lyophilized, for solution, intramuscular82449-004ANDA
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Enquiry

Common questions

Is STERISCIENCE SP Z O O FDA approved?
STERISCIENCE SP Z O O holds 1 FDA-registered establishment in Poland. 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 STERISCIENCE SP Z O O's drugs manufactured?
The FDA register lists Warszawa. Registered operations: analytical testing, labelling, finished drug manufacture, packaging, sterilize.
What drugs does STERISCIENCE SP Z O O make?
16 products are listed under STERISCIENCE SP Z O O in the openFDA NDC Directory, most often as injection, solution; injection, powder, lyophilized, for solution; solution. 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.