Drug

Who makes duloxetine?

33 companies list duloxetine as a human prescription drug, including under the names DRIZALMA SPRINKLE. Forms: capsule, delayed release; capsule, delayed release pellets. 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 duloxetine

CompanyFormsApplicationNDCsRegistered sites
Bryant Ranch PrepackUnited Statescapsule, delayed release; capsule, delayed release pelletsANDAANDA090694, ANDA090776, ANDA203197131
International Medication Systems, Ltd.United Statescapsule, delayed releaseANDAANDA090694, ANDA208706103
ASCLEMED USA INC. DBA ENOVACHEMUnited Statescapsule, delayed release; capsule, delayed release pelletsANDAANDA090776, ANDA20870681
RemedyRepack, IncUnited Statescapsule, delayed releaseANDAANDA090694, ANDA20870681
Sun Pharmaceutical Industries LimitedIndiacapsule, delayed releaseANDA, NDAANDA090745, NDA212516713
HAWAII REPACK INCUnited Statescapsule, delayed release; capsule, delayed release pelletsANDAANDA090776, ANDA20870671
Alembic Pharmaceuticals LimitedIndiacapsule, delayed releaseANDAANDA20294967
Preferred Pharmaceuticals Inc.United Statescapsule, delayed releaseANDAANDA090694, ANDA20870661
NuCare Pharmaceuticals,Inc.United Statescapsule, delayed release; capsule, delayed release pelletsANDAANDA090694, ANDA090776, ANDA20870651
Proficient Rx LPUnited Statescapsule, delayed release; capsule, delayed release pelletsANDAANDA090776, ANDA203197, ANDA20870651
Lupin LimitedIndiacapsule, delayed releaseANDAANDA090694414
Ajanta Pharma LimitedIndiacapsule, delayed releaseANDAANDA20870642
Golden State Medical Supply Inc.United Statescapsule, delayed releaseANDAANDA09069441
BluePoint Laboratories Inc.capsule, delayed releaseANDAANDA20870640
Quallent Pharmaceuticals Health, LLCcapsule, delayed releaseANDAANDA20870640
Zydus Lifesciences LimitedIndiacapsule, delayed releaseANDAANDA090739312
ANI Pharmaceuticals, Inc.United Statescapsule, delayed releaseANDAANDA20233631
Camber Pharmaceuticals, Inc.United Statescapsule, delayed releaseANDAANDA20434331
Coupler LLCUnited Statescapsule, delayed releaseANDAANDA090694, ANDA20870631
Inventia Healthcare Limited.Indiacapsule, delayed releaseANDAANDA20233631
NCS HealthCare of KY, LLC dba Vangard LabsUnited Statescapsule, delayed releaseANDAANDA09069431
St. Mary's Medical Park PharmacyUnited Statescapsule, delayed releaseANDAANDA20870631
ASCEND Therapeutics US, LLCcapsule, delayed releaseANDAANDA20319730
Almatica Pharma Inc.capsule, delayed releaseNDANDA21913130
Aphena Pharma Solutions - Tennessee, LLCcapsule, delayed releaseANDAANDA090694, ANDA20870630
Qingdao BAHEAL Pharmaceutical Co., Ltd.capsule, delayed releaseANDAANDA21059930
Solco healthcare U.S., LLCcapsule, delayed releaseANDAANDA20665330
ADVANCED RX PHARMACY OF TENNESSEE LLCUnited Statescapsule, delayed releaseANDAANDA20870621
Advanced Rx of Tennessee, LLCcapsule, delayed releaseANDAANDA09069420
Preferred Phamaceuticals Inc.capsule, delayed release pelletsANDAANDA09077620
Northwind Health Company, LLCUnited Statescapsule, delayed releaseANDAANDA20870611
PD-Rx Pharmaceuticals Inc.United Statescapsule, delayed releaseANDAANDA20870611
QPharma IncUnited Statescapsule, delayed releaseANDAANDA09069411

Bulk ingredient listings

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Common questions

Who makes duloxetine?
33 companies list duloxetine as a human prescription drug in the openFDA NDC Directory, led by Bryant Ranch Prepack, International Medication Systems, Ltd., ASCLEMED USA INC. DBA ENOVACHEM, RemedyRepack, Inc, Sun Pharmaceutical Industries Limited. 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 DRIZALMA SPRINKLE?
32 companies list duloxetine under an abbreviated new drug application (ANDA), the application type used for generics, and 2 under an NDA or BLA. Listing status is from the NDC Directory; it is not a statement of availability.
Who supplies duloxetine active ingredient?
1 company lists duloxetine as a bulk ingredient, including Hetero Drugs Limited.