Is Sterling Pharmaceutical Services, LLC FDA approved?

Sterling Pharmaceutical Services, LLC holds 4 FDA-registered establishments across 3 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 Sterling Pharmaceutical Services, LLC's drugs manufactured?

At registered sites in the United Kingdom, Italy, the United States. The FDA register lists Cramlington; CORCIANO; Cary, NC; East Carondelet, IL. Registered operations: analytical testing, active ingredient (API) manufacture, finished drug manufacture, packaging, relabelling, repackaging.

What drugs does Sterling Pharmaceutical Services, LLC make?

104 products are listed under Sterling Pharmaceutical Services, LLC in the openFDA NDC Directory, most often as powder; inhalant; injection. The full breakdown by dosage form and route is above. A listing count is not a sales figure.

Sterling Pharmaceutical Services, LLC

Data as of 24 Sept 2026 · How to read this entry

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Registered sites: 4
Active NDC listings: 104
Labeller names: 3
Live patents: 0
Countries: 3
Base: United States

Authorisation

Registered operations

Analytical testing3Active ingredient (API) manufacture3Finished drug manufacture1Packaging1Relabelling1Repackaging1

Sites

Registered establishments

Establishment	Address	Registered for	FEI / DUNS
Sterling Pharma Solutions Limited	Sterling Place, Dudley, Cramlington, NE23 7QG, United Kingdom (GBR)	Analytical testing, Active ingredient (API) manufacture	3002806719349157623
STERLING SPA	VIA DELLA CARBONERIA 30, CORCIANO, PERUGIA 06073, Italy (ITA)	Active ingredient (API) manufacture	3003042159338689703
Sterling Pharma USA LLC	1001 Sheldon Dr Ste 101, Cary, North Carolina (NC) 27513, United States (USA)	Analytical testing, Active ingredient (API) manufacture	3005615885829887660
Sterling Pharmaceutical Services, LLC	102 Coulter Road, East Carondelet, Illinois (IL) 62240, United States (USA)	Analytical testing, Finished drug manufacture, Packaging, Relabelling, Repackaging	3009705561079569189

Catalogue

Drug listings by form and route

104

104 active NDC listings: 103 bulk ingredient, 1 drug for further processing. By marketing category: BULK INGREDIENT 93, BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING 10, DRUG FOR FURTHER PROCESSING 1.

Dosage form	NDCs
powder	95
inhalant	5
injection	1
injection, solution	1
liquid	1
suspension	1

Route	NDCs

Labeller name on the listing	NDCs
sterling pharma solutions limited	42
sterling spa	42
sterling s.p.a.	20

Catalogue

Marketed products

104

Brand	Generic name	Form / route	NDC
-	ABIRATERONE ACETATE	powder	64918-1403BULK INGREDIENT
-	ABIRATERONE ACETATE	powder	64918-1405BULK INGREDIENT
-	ALTRENOGEST	powder	64918-5931BULK INGREDIENT
-	Acrivastine	powder	50384-0300BULK INGREDIENT
-	Anagrelide Hydrochloride, Hydrate	powder	50384-0160BULK INGREDIENT
-	Arformoterol Tartrate	powder	50384-4279BULK INGREDIENT
-	Avatrombopag Maleate	powder	50384-0340BULK INGREDIENT
-	Avatrombopag Maleate	powder	50384-0399BULK INGREDIENT
-	BUDESONIDE	powder	64918-0204BULK INGREDIENT
-	BUDESONIDE	powder	64918-0205BULK INGREDIENT
-	CABOZANTINIB	powder	64918-1924BULK INGREDIENT
-	CICLESONIDE	powder	64918-1112BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING
-	CICLESONIDE	inhalant	64918-1900BULK INGREDIENT
-	Capmatinib Hydrochloride	powder	50384-6500BULK INGREDIENT
-	Centanafadine HCl	powder	50384-0401BULK INGREDIENT
-	Ciclosporin	powder	50384-6300BULK INGREDIENT
-	DEFLAZACORT	powder	64918-1111BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING
-	DEFLAZACORT	powder	64918-1901BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING
-	DESOXYCORTICOSTERONE PIVALATE	powder	64918-0428BULK INGREDIENT
-	DESOXYCORTICOSTERONE PIVALATE	inhalant	64918-0430BULK INGREDIENT
-	DROSPIRENONE	powder	64918-1401BULK INGREDIENT
-	DROSPIRENONE	powder	64918-1903BULK INGREDIENT
-	DUTASTERIDE	powder	64918-1031BULK INGREDIENT
-	DUTASTERIDE	powder	64918-1032BULK INGREDIENT
-	DUTASTERIDE	powder	64918-1904BULK INGREDIENT
-	DYDROGESTERONE	powder	64918-1800BULK INGREDIENT
-	DYDROGESTERONE	powder	64918-1905BULK INGREDIENT
-	Dabrafenib Mesylate	powder	50384-6600BULK INGREDIENT
-	Deoxycholic Acid	powder	50384-0151BULK INGREDIENT
-	Dexmedetomidine Hydrochloride	powder	50384-0100BULK INGREDIENT
-	Dexrazoxane	powder	50384-0200BULK INGREDIENT
-	Diroximel fumarate	powder	50384-5015BULK INGREDIENT
-	ENSIFENTRINE	powder	64918-5929BULK INGREDIENT
-	ESTRADIOL ACETATE	powder	64918-0105BULK INGREDIENT
-	ESTROGENS, CONJUGATED	powder	64918-1410BULK INGREDIENT
-	ESTROPIPATE	powder	64918-0106BULK INGREDIENT
-	ETONOGESTREL	powder	64918-1500BULK INGREDIENT
-	ETONOGESTREL	powder	64918-1906BULK INGREDIENT
-	EXEMESTANE	powder	64918-0621BULK INGREDIENT
-	EXEMESTANE	powder	64918-0622BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING
-	FINASTERIDE	powder	64918-0422BULK INGREDIENT
-	FINASTERIDE	powder	64918-0706BULK INGREDIENT
-	FLUTICASONE FUROATE	inhalant	64918-1117BULK INGREDIENT
-	FLUTICASONE FUROATE	inhalant	64918-1910BULK INGREDIENT
-	FLUTICASONE FUROATE	powder	64918-1915BULK INGREDIENT
-	FLUTICASONE FUROATE	powder	64918-1916BULK INGREDIENT
-	FLUTICASONE FUROATE	powder	64918-1939BULK INGREDIENT
-	FLUTICASONE PROPIONATE	powder	64918-1118BULK INGREDIENT
-	FLUTICASONE PROPIONATE	powder	64918-1600BULK INGREDIENT
-	FLUTICASONE PROPIONATE	powder	64918-1700BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING
-	FULVESTRANT	powder	64918-1402BULK INGREDIENT
-	Fenoldopam mesylate	powder	50384-0130BULK INGREDIENT
-	Ferric Maltol	powder	50384-5100BULK INGREDIENT
-	Fomepizole	liquid	50384-0600BULK INGREDIENT
-	Grapiprant	powder	50384-0500BULK INGREDIENT
-	HALOBETASOL PROPIONATE	powder	64918-1206BULK INGREDIENT
-	Iloperidone	powder	50384-3000BULK INGREDIENT
-	Imatinib mesylate	powder	50384-6200BULK INGREDIENT
-	Isoproterenol Hydrochloride	powder	50384-0363BULK INGREDIENT
-	Isradipine	powder	50384-0120BULK INGREDIENT
-	LEVONORGESTREL ACETATE	powder	64918-1907BULK INGREDIENT
-	Levalbuterol Tartrate	powder	50384-4188BULK INGREDIENT
-	MEDROXYPROGESTERONE ACETATE	powder	64918-1941BULK INGREDIENT
-	METHYLPREDNISOLONE SULEPTANATE	powder	64918-1917BULK INGREDIENT
-	MOMETASONE FUROATE	powder	64918-0330BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING
-	MOMETASONE FUROATE	powder	64918-0424BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING
-	MOMETASONE FUROATE MONOHYDRATE	powder	64918-0331BULK INGREDIENT
-	MOMETASONE FUROATE MONOHYDRATE	inhalant	64918-1912BULK INGREDIENT
-	Mebrofenin	powder	50384-0250BULK INGREDIENT
-	Mebrofenin	powder	50384-0900BULK INGREDIENT
-	Methylenediphosphonic Acid	injection	50384-0425BULK INGREDIENT
-	Midodrine Hydrochloride	powder	50384-0800BULK INGREDIENT
-	Midodrine Hydrochloride	powder	50384-0810BULK INGREDIENT
-	NILOTINIB TRIFLUOROACETATE	powder	64918-1942BULK INGREDIENT
-	NOMEGESTROL ACETATE	powder	64918-1002BULK INGREDIENT
-	NOMEGESTROL ACETATE	powder	64918-1004BULK INGREDIENT
-	NORELGESTROMIN	powder	64918-0104BULK INGREDIENT
-	NORELGESTROMIN	powder	64918-0426BULK INGREDIENT
-	NORETHINDRONE ACETATE	powder	64918-1404BULK INGREDIENT
-	NORGESTIMATE	powder	64918-1003BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING
-	NORGESTIMATE MICRONIZED	powder	64918-1400BULK INGREDIENT
-	NORGESTREL	powder	64918-1940BULK INGREDIENT
-	Nilotinib Hydrochloride	powder	50384-6700BULK INGREDIENT
-	ORFORGLIPRON HEMICALCIUM HYDRATE	powder	64918-5930BULK INGREDIENT
-	Octreotide acetate	powder	50384-6400BULK INGREDIENT
-	Oliceridine Fumarate	injection, solution	50384-0707BULK INGREDIENT
-	Pexidartinib HCl	powder	50384-0750BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING
-	RUXOLITINIB	powder	64918-1902BULK INGREDIENT
-	Ractopamine Hydrochloride	suspension	50384-5060DRUG FOR FURTHER PROCESSING
-	Selamectin	powder	50384-4741BULK INGREDIENT
-	Sodium Thiosulfate Pentahydrate	powder	50384-0330BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING
-	TAZEMETOSTAT HYDROBROMIDE	powder	50384-4000BULK INGREDIENT
-	TETRAKIS(2-METHOXYISOBUTYLISOCYANIDE)COPPER(I) TETRAFLUOROBORATE	powder	50384-2804BULK INGREDIENT
-	TRILOSTANE	powder	64918-0725BULK INGREDIENT
-	Taurolidine	powder	50384-0235BULK INGREDIENT
-	Tetrakis(2-methoxy isobutyl isonitrile) copper(I) tetrafluoroborate	powder	50384-0700BULK INGREDIENT
-	Toceranib Phosphate	powder	50384-4739BULK INGREDIENT
-	UMECLIDINIUM BROMIDE	powder	64918-1918BULK INGREDIENT
-	UMECLIDINIUM BROMIDE	powder	64918-1920BULK INGREDIENT
-	VILANTEROL TRIFENATATE	powder	64918-1919BULK INGREDIENT
-	VILANTEROL TRIFENATATE	powder	64918-1921BULK INGREDIENT
-	Valsartan	powder	50384-6100BULK INGREDIENT
-	Zileuton	powder	50384-5000BULK INGREDIENT
-	fuzapladib sodium	powder	50384-0287BULK INGREDIENT

Neighbours

Registered in the same town

Pharmaron Manufacturing Services (UK) LimitedCramlington, GBR
Eurofins BioPharma Product Testing ENCO, LLCCary, NC

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Enquiry

Common questions

Is Sterling Pharmaceutical Services, LLC FDA approved?: Sterling Pharmaceutical Services, LLC holds 4 FDA-registered establishments across 3 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 Sterling Pharmaceutical Services, LLC's drugs manufactured?: At registered sites in the United Kingdom, Italy, the United States. The FDA register lists Cramlington; CORCIANO; Cary, NC; East Carondelet, IL. Registered operations: analytical testing, active ingredient (API) manufacture, finished drug manufacture, packaging, relabelling, repackaging.
What drugs does Sterling Pharmaceutical Services, LLC make?: 104 products are listed under Sterling Pharmaceutical Services, LLC in the openFDA NDC Directory, most often as powder; inhalant; injection. 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.