Is FIS FABBRICA ITALIANA SINTETICI SPA FDA approved?

FIS FABBRICA ITALIANA SINTETICI SPA holds 3 FDA-registered establishments in Italy. 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 FIS FABBRICA ITALIANA SINTETICI SPA's drugs manufactured?

The FDA register lists Lonigo; Montecchio Maggiore; Termoli. Registered operations: analytical testing, active ingredient (API) manufacture, finished drug manufacture.

What drugs does FIS FABBRICA ITALIANA SINTETICI SPA make?

128 products are listed under FIS FABBRICA ITALIANA SINTETICI SPA in the openFDA NDC Directory, most often as powder; liquid. The full breakdown by dosage form and route is above. A listing count is not a sales figure.

FIS FABBRICA ITALIANA SINTETICI SPA

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

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Registered sites: 3
Active NDC listings: 128
Labeller names: 5
Live patents: 0
Countries: 1
Base: Italy

Authorisation

Registered operations

Analytical testing3Active ingredient (API) manufacture3Finished drug manufacture1

Sites

Registered establishments

Establishment	Address	Registered for	FEI / DUNS
F.I.S. FABBRICA ITALIANA SINTETICI S.P.A.Registrant: FIS FABBRICA ITALIANA SINTETICI SPA	Via Dovaro snc, Lonigo, Vicenza 36045, Italy (ITA)	Analytical testing, Active ingredient (API) manufacture	3002808541437769315
F.I.S. FABBRICA ITALIANA SINTETICI S.P.A.Registrant: FIS FABBRICA ITALIANA SINTETICI SPA	Viale Milano 26, Montecchio Maggiore, Vicenza 36075, Italy (ITA)	Analytical testing, Active ingredient (API) manufacture, Finished drug manufacture	3002806961431189117
F.I.S. FABBRICA ITALIANA SINTETICI S.P.A.Registrant: FIS FABBRICA ITALIANA SINTETICI SPA	Via Massimo D'Antona, 13, Termoli, Campobasso 86039, Italy (ITA)	Analytical testing, Active ingredient (API) manufacture	3008347496339689422

Catalogue

Drug listings by form and route

128

128 active NDC listings: 128 bulk ingredient. By marketing category: BULK INGREDIENT 128.

Dosage form	NDCs
powder	127
liquid	1

Route	NDCs

Labeller name on the listing	NDCs
f.i.s. fabbrica italiana sintetici s.p.a.	102
f.i.s. fabbrica italiana sintetici s.p.a.	13
f.i.s. - fabbrica italiana sintetici s.p.a.	8
f.i.s. fabbrica italiana sintetici spa	4
f.i.s. fabbrica italiana sintetici s.p.a.	1

Catalogue

Marketed products

128

Brand	Generic name	Form / route	NDC
-	ACETYLCYSTEINE	powder	52133-0002BULK INGREDIENT
-	AMG 423 2HCL	powder	48087-0156BULK INGREDIENT
-	ARMODAFINIL	powder	48087-0066BULK INGREDIENT
-	ATALUREN	powder	48087-0138BULK INGREDIENT
-	CARBAMAZEPINE	powder	48087-0051BULK INGREDIENT
-	CARBAMAZEPINE	powder	48087-0052BULK INGREDIENT
-	CHLORDIAZEPOXIDE	powder	48087-4402BULK INGREDIENT
-	CHLORDIAZEPOXIDE HYDROCHLORIDE	powder	48087-0129BULK INGREDIENT
-	CHLORDIAZEPOXIDE HYDROCHLORIDE	powder	48087-4401BULK INGREDIENT
-	CLOBAZAM	powder	48087-0094BULK INGREDIENT
-	CLOBAZAM	powder	48087-0117BULK INGREDIENT
-	CLOMIPHENE CITRATE	powder	48087-0025BULK INGREDIENT
-	CLOMIPHENE CITRATE	powder	48087-0144BULK INGREDIENT
-	CLONAZEPAM	powder	48087-0014BULK INGREDIENT
-	CLONAZEPAM	powder	48087-0038BULK INGREDIENT
-	CLOTRIMAZOLE	powder	48087-0084BULK INGREDIENT
-	CLOTRIMAZOLE	powder	48087-0086BULK INGREDIENT
-	CLOTRIMAZOLE	powder	48087-0088BULK INGREDIENT
-	DARIFENACIN HYDROBROMIDE	powder	48087-0110BULK INGREDIENT
-	DELORAZEPAM	powder	48087-0108BULK INGREDIENT
-	DIAZEPAM	powder	48087-0005BULK INGREDIENT
-	DIAZEPAM	powder	48087-0112BULK INGREDIENT
-	DILTIAZEM HYDROCHLORIDE	powder	52133-0013BULK INGREDIENT
-	DORZOLAMIDE HYDROCHLORIDE	powder	52133-0031BULK INGREDIENT
-	Doravirine SDI	powder	48087-0145BULK INGREDIENT
-	Doravirine SDI	powder	48087-0169BULK INGREDIENT
-	EFAVIRENZ	powder	48087-0062BULK INGREDIENT
-	EFAVIRENZ	powder	48087-0127BULK INGREDIENT
-	EFAVIRENZ	powder	48087-0128BULK INGREDIENT
-	EFAVIRENZ	powder	48087-0131BULK INGREDIENT
-	ELETRIPTAN HYDROBROMIDE	powder	48087-0090BULK INGREDIENT
-	ELETRIPTAN HYDROBROMIDE	powder	48087-0102BULK INGREDIENT
-	ELVITEGRAVIR	powder	48087-0107BULK INGREDIENT
-	ENCLOMIPHENE CITRATE	powder	48087-0132BULK INGREDIENT
-	ENTACAPONE	powder	48087-0080BULK INGREDIENT
-	ENTACAPONE	powder	48087-0109BULK INGREDIENT
-	ERLOTINIB HYDROCHLORIDE	powder	48087-0133BULK INGREDIENT
-	ESOMEPRAZOLE MAGNESIUM DIHYDRATE	powder	48087-0111BULK INGREDIENT
-	ESOMEPRAZOLE MAGNESIUM TRIHYDRATE	powder	48087-0136BULK INGREDIENT
-	ESTAZOLAM	powder	48087-0031BULK INGREDIENT
-	ESTRADIOL	powder	48087-0159BULK INGREDIENT
-	FINASTERIDE	powder	48087-0092BULK INGREDIENT
-	FLURAZEPAM HYDROCHLORIDE	powder	48087-0021BULK INGREDIENT
-	FLUVASTATIN SODIUM	powder	48087-0093BULK INGREDIENT
-	FOSFOMYCIN TROMETAMOL	powder	52133-0018BULK INGREDIENT
-	FUROSEMIDE	powder	48087-0053BULK INGREDIENT
-	FUROSEMIDE	powder	48087-0054BULK INGREDIENT
-	Fosaprepitant Dimeglumine	powder	52133-0045BULK INGREDIENT
-	GABAPENTIN	powder	52133-0025BULK INGREDIENT
-	IIVABRADINE	powder	48087-0119BULK INGREDIENT
-	IMATINIB	powder	48087-0143BULK INGREDIENT
-	IMATINIB MESILATE	powder	48087-0121BULK INGREDIENT
-	INDOMETHACIN	powder	48087-0069BULK INGREDIENT
-	INDOMETHACIN	powder	48087-0070BULK INGREDIENT
-	INDOMETHACIN SODIUM	powder	48087-0116BULK INGREDIENT
-	LAPATINIB DITOSYLATE	powder	48087-0095BULK INGREDIENT
-	LENACAPAVIR SODIUM	powder	48087-0172BULK INGREDIENT
-	LORAZEPAM	powder	48087-0076BULK INGREDIENT
-	Levothyroxine Sodium	powder	48087-0140BULK INGREDIENT
-	MIDAZOLAM	powder	48087-0098BULK INGREDIENT
-	MIDAZOLAM HYDROCHLORIDE	powder	48087-0103BULK INGREDIENT
-	MIDAZOLAM MALEATE	powder	48087-0104BULK INGREDIENT
-	NEBIVOLOL HYDROCHLORIDE	powder	52133-0039BULK INGREDIENT
-	NIFEDIPINE	powder	52133-0009BULK INGREDIENT
-	NIFEDIPINE	powder	52133-0028BULK INGREDIENT
-	NITROFURANTOIN	powder	48087-0009BULK INGREDIENT
-	NITROFURANTOIN	powder	48087-0029BULK INGREDIENT
-	NITROFURANTOIN	powder	48087-0081BULK INGREDIENT
-	NITROFURANTOIN	powder	48087-0097BULK INGREDIENT
-	NITROFURANTOIN	powder	48087-0146BULK INGREDIENT
-	NITROFURANTOIN	powder	48087-0147BULK INGREDIENT
-	NITROFURANTOIN	powder	48087-0148BULK INGREDIENT
-	NITROFURANTOIN MONOHYDRATE	powder	48087-0026BULK INGREDIENT
-	NITROFURANTOIN MONOHYDRATE	powder	48087-0064BULK INGREDIENT
-	NITROFURANTOIN MONOHYDRATE	powder	48087-0101BULK INGREDIENT
-	NITROFURANTOIN MONOHYDRATE	powder	48087-0141BULK INGREDIENT
-	NITROFURANTOIN MONOHYDRATE	powder	48087-0142BULK INGREDIENT
-	OLOPATADINE HYDROCHLORIDE	powder	48087-0100BULK INGREDIENT
-	OLOPATADINE HYDROCHLORIDE	powder	48087-0165BULK INGREDIENT
-	OLOPATADINE HYDROCHLORIDE	powder	52133-0036BULK INGREDIENT
-	OMECAMTIV MECARBIL	powder	48087-0167BULK INGREDIENT
-	OXAZEPAM	powder	48087-0087BULK INGREDIENT
-	OXCARBAZEPINE	powder	48087-0046BULK INGREDIENT
-	OXCARBAZEPINE	powder	48087-0114BULK INGREDIENT
-	OXCARBAZEPINE	powder	48087-0115BULK INGREDIENT
-	OXCARBAZEPINE	powder	48087-0118BULK INGREDIENT
-	OXCARBAZEPINE	powder	48087-0157BULK INGREDIENT
-	OXCARBAZEPINE	powder	48087-0158BULK INGREDIENT
-	PENTAZOCINE	powder	48087-0007BULK INGREDIENT
-	PENTAZOCINE HYDROCHLORIDE	powder	48087-0077BULK INGREDIENT
-	PROCARBAZINE HYDROCHLORIDE	powder	48087-0050BULK INGREDIENT
-	PROCARBAZINE HYDROCHLORIDE	powder	48087-0085BULK INGREDIENT
-	PROGESTERONE	powder	48087-0057BULK INGREDIENT
-	PROGESTERONE	powder	48087-0105BULK INGREDIENT
-	PROPOFOL	liquid	52133-0023BULK INGREDIENT
-	QUETIAPINE FUMARATE	powder	48087-0068BULK INGREDIENT
-	RANOLAZINE	powder	48087-0082BULK INGREDIENT
-	RANOLAZINE	powder	48087-0106BULK INGREDIENT
-	SITAGLIPTIN GEN1 (INHIBITED)	powder	48087-0164BULK INGREDIENT
-	SITAGLIPTIN PHOSPHATE	powder	48087-0078BULK INGREDIENT
-	SOFOSBUVIR	powder	48087-0120BULK INGREDIENT
-	SUGAMMADEX	powder	48087-0151BULK INGREDIENT
-	SUGAMMADEX	powder	48087-0153BULK INGREDIENT
-	SUGAMMADEX CRUDE	powder	48087-0152BULK INGREDIENT
-	SULINDAC	powder	52133-0007BULK INGREDIENT
-	SUMATRIPTAN SUCCINATE	powder	48087-0075BULK INGREDIENT
-	Sitagliptin Phosphate	powder	48087-0154BULK INGREDIENT
-	Sitagliptin Phosphate	powder	48087-0155BULK INGREDIENT
-	Sotagliflozin	powder	48087-0150BULK INGREDIENT
-	TEI-6720	powder	48087-0071BULK INGREDIENT
-	TEI-6720	powder	48087-0125BULK INGREDIENT
-	TEI-6720	powder	48087-0162BULK INGREDIENT
-	TEMAZEPAM	powder	48087-0016BULK INGREDIENT
-	TEMAZEPAM	powder	48087-0045BULK INGREDIENT
-	TERBINAFINE HYDROCHLORIDE	powder	48087-0079BULK INGREDIENT
-	TESTOSTERONE	powder	48087-0113BULK INGREDIENT
-	TESTOSTERONE CYPIONATE	powder	48087-0096BULK INGREDIENT
-	TESTOSTERONE ENANTHATE	powder	48087-0137BULK INGREDIENT
-	TESTOSTERONE PROPIONATE	powder	48087-0134BULK INGREDIENT
-	TESTOSTERONE UNDECANOATE	powder	48087-0135BULK INGREDIENT
-	TROFINETIDE	powder	48087-0160BULK INGREDIENT
-	TROFINETIDE HYDRATE	powder	48087-0168BULK INGREDIENT
-	TSE-424 ACETATE	powder	52133-0032BULK INGREDIENT
-	ULOTARONT HYDROCHLORIDE	powder	48087-0161BULK INGREDIENT
-	VALBENAZINE DITOSYLATE	powder	48087-0139BULK INGREDIENT
-	VALBENAZINE DITOSYLATE	powder	48087-0166BULK INGREDIENT
-	VELPATASVIR	powder	48087-0123BULK INGREDIENT
-	VELPATASVIR SDD	powder	48087-0124BULK INGREDIENT

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Erregierre SpA2 sites · 36 NDC
Newchem S.p.A.2 sites · 33 NDC
Novo Nordisk Production Belgium SA2 sites · 24 NDC
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Italfarmaco S.A.2 sites · 15 NDC
Flamma USA LLC4 sites · 13 NDC
Lusochimica SPA2 sites · 13 NDC

Enquiry

Common questions

Is FIS FABBRICA ITALIANA SINTETICI SPA FDA approved?: FIS FABBRICA ITALIANA SINTETICI SPA holds 3 FDA-registered establishments in Italy. 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 FIS FABBRICA ITALIANA SINTETICI SPA's drugs manufactured?: The FDA register lists Lonigo; Montecchio Maggiore; Termoli. Registered operations: analytical testing, active ingredient (API) manufacture, finished drug manufacture.
What drugs does FIS FABBRICA ITALIANA SINTETICI SPA make?: 128 products are listed under FIS FABBRICA ITALIANA SINTETICI SPA in the openFDA NDC Directory, most often as powder; liquid. 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.