Drug

Who makes quetiapine fumarate?

32 companies list quetiapine fumarate as a human prescription drug. Forms: tablet; tablet, extended release; tablet, film coated. Routes: oral.

Labellers from the openFDA NDC Directory. A labeller is the firm named on the label, not necessarily the site that made the product, and a listing is not an FDA approval. Data as of 24 Sept 2026. Methodology

Companies listing quetiapine fumarate

CompanyFormsApplicationNDCsRegistered sites
Bryant Ranch PrepackUnited Statestablet; tablet, film coatedANDAANDA091388, ANDA201109, ANDA201190231
RemedyRepack, IncUnited Statestablet; tablet, film coatedANDAANDA091388, ANDA201109, ANDA202674131
International Medication Systems, Ltd.United Statestablet; tablet, film coatedANDAANDA091388, ANDA201109, ANDA20150483
Proficient Rx LPUnited Statestablet; tablet, film coatedANDAANDA091388, ANDA201504, ANDA20215281
Preferred Pharmaceuticals Inc.United Statestablet; tablet, film coatedANDAANDA091388, ANDA201109, ANDA20150471
Rising Pharma Holdings, Inc.United Statestablet, film coatedANDAANDA09138871
Lupin LimitedIndiatabletANDAANDA201109614
Sun Pharmaceutical Industries LimitedIndiatablet, film coatedANDAANDA201190613
Alembic Pharmaceuticals LimitedIndiatablet, film coatedANDAANDA20339067
Macleods Pharmaceuticals LimitedIndiatablet, film coatedANDAANDA20335965
Unichem Laboratories Limited, IndiaIndiatablet, film coatedANDAANDA20267465
Hikma Pharmaceuticals USA Inc.United StatestabletANDAANDA090120, ANDA09074964
Camber Pharmaceuticals, Inc.United Statestablet, film coatedANDAANDA20431661
Golden State Medical Supply Inc.United StatestabletANDAANDA090120, ANDA09074961
NCS HealthCare of KY, LLC dba Vangard LabsUnited Statestablet, film coatedANDAANDA20267461
XLCare Pharmaceuticals Inc.United Statestablet, film coatedANDAANDA20431661
AvPAKtabletANDAANDA20150460
Northstar Rx, LLC,tablet, film coatedANDAANDA09138860
ACCORD HEALTHCARE LIMITEDUnited Kingdomtablet, extended releaseANDAANDA090681, ANDA20625252
Direct RxUnited Statestablet; tablet, film coatedANDAANDA091388, ANDA20150451
NuCare Pharmaceuticals,Inc.United Statestablet; tablet, film coatedANDAANDA091388, ANDA201109, ANDA20150451
Aphena Pharma Solutions - Tennessee, LLCtabletANDAANDA090120, ANDA09074950
Ingenus Pharmaceuticals, LLCtablet, extended releaseANDAANDA20894750
Coupler LLCUnited Statestablet; tablet, film coatedANDAANDA091388, ANDA201109, ANDA20119041
Novast Laboratories Ltd.Chinatablet, extended releaseANDAANDA20894741
Quallent Pharmaceuticals Health, LLCtabletANDAANDA20110940
St. Mary's Medical Park PharmacyUnited Statestablet; tablet, film coatedANDAANDA201109, ANDA20431631
Aurobindo Pharma LimitedIndiatablet, film coatedANDAANDA09138826
ADVANCED RX PHARMACY OF TENNESSEE LLCUnited Statestablet; tablet, film coatedANDAANDA201504, ANDA20267421
Unit Dose Solutions, Inc.United StatestabletANDAANDA20110911
: Preferred Pharmaceuticals Inc.tabletANDAANDA20110910
Advanced Rx of Tennessee, LLCtabletANDAANDA20110910

Bulk ingredient listings

Enquiry

Common questions

Who makes quetiapine fumarate?
32 companies list quetiapine fumarate as a human prescription drug in the openFDA NDC Directory, led by Bryant Ranch Prepack, RemedyRepack, Inc, International Medication Systems, Ltd., Proficient Rx LP, Preferred Pharmaceuticals Inc.. Each is the labeller, the firm named on the label; the product may be made at a site registered to another company.
Is there a generic quetiapine fumarate?
32 companies list quetiapine fumarate under an abbreviated new drug application (ANDA), the application type used for generics. Listing status is from the NDC Directory; it is not a statement of availability.
Who supplies quetiapine fumarate active ingredient?
28 companies list quetiapine fumarate as a bulk ingredient, including Hetero Labs Limited, AARTI PHARMALABS LIMITED, Ajinomoto OmniChem N.V., Aurobindo Pharma Limited.