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Register entryShortage reported

Granules Pharmaceuticals Inc.

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Registered sites
8
Drug products
301
Live patents
0
Countries
2
Base
India
Authorisation

Registered operations

What the FDA has registered these sites to do. This is the regulatory record, not a marketing claim.

Analytical testingActive ingredient (API) manufactureLabellingFinished drug manufacturePackagingRelabellingRepackaging
Sites

Facilities

8
SiteLocationOperationsFEI
Granules India LimitedAnakapalliIndiaAnalytical testing, Active ingredient (API) manufacture, Labelling, Finished drug manufacture, Packaging3012884557
Granules India LimitedAnakapalliIndiaAnalytical testing, Active ingredient (API) manufacture, Labelling, Packaging3006583291
Granules India LimitedMedchal-Malkajgiri DistrictIndiaAnalytical testing, Labelling, Finished drug manufacture, Packaging3004097901
Granules India LimitedMedchal-Malkajgiri DistrictIndiaAnalytical testing, Active ingredient (API) manufacture, Labelling, Packaging3001319869
Granules India LimitedSangareddyIndiaAnalytical testing, Active ingredient (API) manufacture, Labelling, Packaging3003723146
GRANULES LIFE SCIENCES PRIVATE LIMITEDShameerpet Medchal-MalkajgiriIndiaAnalytical testing, Labelling, Finished drug manufacture, Packaging3030495702
Granules Pharmaceuticals Inc.Chantilly, VAUnited StatesAnalytical testing, Labelling, Finished drug manufacture, Packaging3011585184
Granules Consumer Health LLCManassas, VAUnited StatesLabelling, Packaging, Relabelling, Repackaging3024359799
Alert

Products in shortage

7
DrugPresentationAvailability
Amphetamine Aspartate Monohydrate, Amphetamine Sulfate, Dextroamphetamine Saccharate, Dextroamphetamine Sulfate TabletAmphetamine Aspartate Monohydrate, Amphetamine Sulfate, Dextroamphetamine Saccharate, Dextroamphetamine Sulfate, Tablet, 1.875 mg; 1.875 mg; 1.875 mg; 1.875 mg (NDC 70010-112-01)Unavailable
Amphetamine Aspartate Monohydrate, Amphetamine Sulfate, Dextroamphetamine Saccharate, Dextroamphetamine Sulfate TabletAmphetamine Aspartate Monohydrate, Amphetamine Sulfate, Dextroamphetamine Saccharate, Dextroamphetamine Sulfate, Tablet, 2.5 mg; 2.5 mg; 2.5 mg; 2.5 mg (NDC 70010-113-01)Unavailable
Amphetamine Aspartate Monohydrate, Amphetamine Sulfate, Dextroamphetamine Saccharate, Dextroamphetamine Sulfate TabletAmphetamine Aspartate Monohydrate, Amphetamine Sulfate, Dextroamphetamine Saccharate, Dextroamphetamine Sulfate, Tablet, 3.125 mg; 3.125 mg; 3.125 mg; 3.125 mg (NDC 70010-114-01)Unavailable
Amphetamine Aspartate Monohydrate, Amphetamine Sulfate, Dextroamphetamine Saccharate, Dextroamphetamine Sulfate TabletAmphetamine Aspartate Monohydrate, Amphetamine Sulfate, Dextroamphetamine Saccharate, Dextroamphetamine Sulfate, Tablet, 3.75 mg; 3.75 mg; 3.75 mg; 3.75 mg (NDC 70010-115-01)Unavailable
Amphetamine Aspartate Monohydrate, Amphetamine Sulfate, Dextroamphetamine Saccharate, Dextroamphetamine Sulfate TabletAmphetamine Aspartate Monohydrate, Amphetamine Sulfate, Dextroamphetamine Saccharate, Dextroamphetamine Sulfate, Tablet, 7.5 mg; 7.5 mg; 7.5 mg; 7.5 mg (NDC 70010-117-01)Unavailable
Amphetamine Aspartate Monohydrate, Amphetamine Sulfate, Dextroamphetamine Saccharate, Dextroamphetamine Sulfate TabletAmphetamine Aspartate Monohydrate, Amphetamine Sulfate, Dextroamphetamine Saccharate, Dextroamphetamine Sulfate, Tablet, 5 mg; 5 mg; 5 mg; 5 mg (NDC 70010-116-01)Unavailable
Amphetamine Aspartate Monohydrate, Amphetamine Sulfate, Dextroamphetamine Saccharate, Dextroamphetamine Sulfate TabletAmphetamine Aspartate Monohydrate, Amphetamine Sulfate, Dextroamphetamine Saccharate, Dextroamphetamine Sulfate, Tablet, 1.25 mg; 1.25 mg; 1.25 mg; 1.25 mg (NDC 70010-111-01)Unavailable
Catalogue

Marketed products

301

Showing 150 of 301.

BrandGeneric nameFormCategory
ACETAMINOPHENACETAMINOPHENTABLET, EXTENDED RELEASEANDA
ACETAMINOPHENACETAMINOPHENTABLET, EXTENDED RELEASEANDA
ACETAMINOPHENACETAMINOPHENTABLET, EXTENDED RELEASEANDA
ACETAMINOPHENACETAMINOPHENTABLET, EXTENDED RELEASEANDA
ACETAMINOPHENACETAMINOPHENTABLETOTC MONOGRAPH DRUG
Aacetaminophen and IbuprofenAcetaminophen and IbuprofenTABLETANDA
-AcetaminophenTABLETEXPORT ONLY
-AcetaminophenTABLETEXPORT ONLY
-AcetaminophenCAPSULE, GELATIN COATEDDRUG FOR FURTHER PROCESSING
-AcetaminophenPOWDEREXPORT ONLY
AcetaminophenAcetaminophenTABLETOTC MONOGRAPH DRUG
AcetaminophenAcetaminophenTABLETOTC MONOGRAPH DRUG
AcetaminophenAcetaminophenTABLET, FILM COATED, EXTENDED RELEASEANDA
-Acetaminophen 80% and Diphenhydramine Hcl 4% Directly compressible granulesPOWDERDRUG FOR FURTHER PROCESSING
Acetaminophen Diphenhydramine HClAcetaminophen Diphenhydramine HClTABLETOTC MONOGRAPH DRUG
-Acetaminophen Directly compressible granules 90%POWDERDRUG FOR FURTHER PROCESSING
-Acetaminophen Directly compressible granules 90%POWDERDRUG FOR FURTHER PROCESSING
-Acetaminophen Directly compressible granules 90%POWDERDRUG FOR FURTHER PROCESSING
-Acetaminophen Extra StrengthTABLETEXPORT ONLY
-Acetaminophen and Diphenhydramine HydrochlorideTABLETDRUG FOR FURTHER PROCESSING
-Acetaminophen and Diphenhydramine HydrochlorideCAPSULEDRUG FOR FURTHER PROCESSING
-Acetaminophen and IbuprofenTABLETDRUG FOR FURTHER PROCESSING
Acetaminophen and IbuprofenAcetaminophen and IbuprofenTABLETANDA
Acetaminophen and Ibuprofen Back PainAcetaminophen and IbuprofenTABLETANDA
Acetaminophen, Aspirin and CaffeineAcetaminophen, Aspirin and CaffeineTABLETANDA
Amphetamine SulfateAmphetamine SulfateTABLETANDA
Amphetamine SulfateAmphetamine SulfateTABLETANDA
-Atazanavir SulfatePOWDERDRUG FOR FURTHER PROCESSING
-Avatrombopag MaleatePOWDERDRUG FOR FURTHER PROCESSING
-BORTEZOMIBPOWDERBULK INGREDIENT
-BUPROPIONPOWDERBULK INGREDIENT
BUPROPION HYDROCHLORIDEbupropion hydrochlorideTABLET, FILM COATED, EXTENDED RELEASEANDA
BUPROPION HYDROCHLORIDEbupropion hydrochlorideTABLET, FILM COATED, EXTENDED RELEASEANDA
BUPROPION HYDROCHLORIDEbupropion hydrochlorideTABLET, FILM COATED, EXTENDED RELEASEANDA
-BrinzolamidePOWDEREXPORT ONLY
Bupropion hydrochlorideBupropion hydrochlorideTABLET, EXTENDED RELEASEANDA
Bupropion hydrochlorideBupropion hydrochlorideTABLET, EXTENDED RELEASEANDA
Butalbital, Acetaminophen and CaffeineButalbital, Acetaminophen and CaffeineCAPSULEANDA
-COMPRESSO IBU 85 PARPOWDERDRUG FOR FURTHER PROCESSING
-Calcium OxybatePOWDERDRUG FOR FURTHER PROCESSING
-Cetirizine HydrochloridePOWDERDRUG FOR FURTHER PROCESSING
Cetirizine HydrochlorideCetirizine HydrochlorideTABLETANDA
Cetirizine hydrochlorideCetirizine hydrochlorideTABLET, COATEDANDA
Cetirizine hydrochlorideCetirizine hydrochlorideTABLET, COATEDANDA
Cetirizine hydrochloride - HIVESCetirizine hydrochlorideTABLET, COATEDANDA
ClotrimazoleClotrimazoleSOLUTIONOTC MONOGRAPH DRUG
ClotrimazoleClotrimazoleSOLUTIONOTC MONOGRAPH DRUG
ColchicineColchicineCAPSULEANDA
ColchicineColchicineTABLET, FILM COATEDANDA
-Compresso MF 95PPOWDERDRUG FOR FURTHER PROCESSING
-Compresso MF 95PPOWDEREXPORT ONLY
-Compresso PAP 90 CPCPOWDERDRUG FOR FURTHER PROCESSING
-Compresso PAP 90 CPFPOWDERDRUG FOR FURTHER PROCESSING
-Compresso PAP 90CPFPOWDERDRUG FOR FURTHER PROCESSING
-DASATINIBPOWDERBULK INGREDIENT
-DASATINIB MonohydratePOWDERBULK INGREDIENT
DEXMETHYLPHENIDATE HYDROCHLORIDEDEXMETHYLPHENIDATE HYDROCHLORIDECAPSULE, EXTENDED RELEASEANDA
DEXMETHYLPHENIDATE HYDROCHLORIDEDEXMETHYLPHENIDATE HYDROCHLORIDECAPSULE, EXTENDED RELEASEANDA
DEXMETHYLPHENIDATE HYDROCHLORIDEDEXMETHYLPHENIDATE HYDROCHLORIDECAPSULE, EXTENDED RELEASEANDA
DEXMETHYLPHENIDATE HYDROCHLORIDEDEXMETHYLPHENIDATE HYDROCHLORIDECAPSULE, EXTENDED RELEASEANDA
DEXMETHYLPHENIDATE HYDROCHLORIDEDEXMETHYLPHENIDATE HYDROCHLORIDECAPSULE, EXTENDED RELEASEANDA
DEXMETHYLPHENIDATE HYDROCHLORIDEDEXMETHYLPHENIDATE HYDROCHLORIDECAPSULE, EXTENDED RELEASEANDA
DEXMETHYLPHENIDATE HYDROCHLORIDEDEXMETHYLPHENIDATE HYDROCHLORIDECAPSULE, EXTENDED RELEASEANDA
DEXMETHYLPHENIDATE HYDROCHLORIDEDEXMETHYLPHENIDATE HYDROCHLORIDECAPSULE, EXTENDED RELEASEANDA
-DapagliflozinPOWDERDRUG FOR FURTHER PROCESSING
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine SulfateDextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine SulfateTABLETANDA
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine SulfateDextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine SulfateTABLETANDA
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine SulfateDextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine SulfateTABLETANDA
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine SulfateDextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine SulfateTABLETANDA
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine SulfateDextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine SulfateTABLETANDA
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine SulfateDextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine SulfateTABLETANDA
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine SulfateDextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine SulfateTABLETANDA
-Di-tert-butyl ((S)-6-oxo-6-(((S)-1-phenylpropan-2-yl) amino) hexane-1,5-diyl) dicarbamatePOWDERBULK INGREDIENT
-Dimethyl FumaratePOWDERBULK INGREDIENT
Dofetilide 0.125mgDofetilide 0.125mgCAPSULEANDA
Dofetilide 0.25mgDofetilide 0.25mgCAPSULEANDA
Dofetilide 0.5mgDofetilide 0.5mgCAPSULEANDA
-Eltrombopag OlaminePOWDERBULK INGREDIENT
-EmpagliflozinPOWDERBULK INGREDIENT
-Esomeprazole Magnesium TrihydratePOWDERDRUG FOR FURTHER PROCESSING
Esomeprazole magnesiumEsomeprazole magnesiumCAPSULE, DELAYED RELEASEANDA
Esomeprazole magnesiumEsomeprazole magnesiumCAPSULE, DELAYED RELEASEANDA
Fexofenadine HCLFexofenadine HCLTABLETANDA
-Fexofenadine HydrochloridePOWDERBULK INGREDIENT
Fexofenadine HydrochlorideFexofenadine HydrochlorideTABLETANDA
Fexofenadine HydrochlorideFexofenadine HydrochlorideTABLETANDA
Fexofenadine HydrochlorideFexofenadine HydrochlorideTABLETANDA
Fexofenadine HydrochlorideFexofenadine HydrochlorideTABLET, FILM COATEDANDA
Fexofenadine HydrochlorideFexofenadine HydrochlorideTABLET, FILM COATEDANDA
GABAPENTINGABAPENTINCAPSULEANDA
GABAPENTINGABAPENTINCAPSULEANDA
GABAPENTINGABAPENTINCAPSULEANDA
GABAPENTINGABAPENTINCAPSULEANDA
GABAPENTINGABAPENTINCAPSULEANDA
GABAPENTINGABAPENTINCAPSULEANDA
GUAIFENESINGUAIFENESINTABLET, EXTENDED RELEASEANDA
GUAIFENESINGUAIFENESINTABLET, EXTENDED RELEASEANDA
GUAIFENESINGUAIFENESINTABLET, EXTENDED RELEASEANDA
GUAIFENESINGUAIFENESINTABLET, EXTENDED RELEASEANDA
GUAIFENESINGUAIFENESINTABLET, EXTENDED RELEASEANDA
-GabapentinPOWDERBULK INGREDIENT
GabapentinGabapentinTABLET, FILM COATEDANDA
GabapentinGabapentinTABLET, FILM COATEDANDA
Glycopyrrolate Oral SolutionGlycopyrrolateSOLUTIONANDA
-GuaifenesinPOWDEREXPORT ONLY
-GuaifenesinPOWDEREXPORT ONLY
GuaifenesinGuaifenesinTABLET, EXTENDED RELEASEANDA
GuaifenesinGuaifenesinTABLET, EXTENDED RELEASEANDA
-Guaifenesin Directly compressible Granules 95%POWDERDRUG FOR FURTHER PROCESSING
-Guaifenesin Directly compressible granules 95%POWDERDRUG FOR FURTHER PROCESSING
Guaifenesin and Pseudoephedrine HClGuaifenesin and Pseudoephedrine HClTABLET, EXTENDED RELEASEANDA
Guaifenesin and Pseudoephedrine HClGuaifenesin and Pseudoephedrine HClTABLET, EXTENDED RELEASEANDA
Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenTABLETANDA
Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenTABLETANDA
Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenTABLETANDA
IBUPROFENIBUPROFENTABLETANDA
IBUPROFENIBUPROFENTABLETANDA
-IBUPROFENTABLET, FILM COATEDDRUG FOR FURTHER PROCESSING
IbuprofenIbuprofenTABLET, FILM COATEDANDA
IbuprofenIbuprofenTABLET, FILM COATEDANDA
-IbuprofenTABLETDRUG FOR FURTHER PROCESSING
-IbuprofenTABLETDRUG FOR FURTHER PROCESSING
IbuprofenIbuprofenTABLETANDA
IbuprofenIbuprofenTABLETANDA
IbuprofenIbuprofenTABLETANDA
IbuprofenIbuprofenTABLETANDA
IbuprofenIbuprofenTABLET, FILM COATEDANDA
IbuprofenIbuprofenTABLET, FILM COATEDANDA
-Ibuprofen Directly compressible granules 66%POWDERDRUG FOR FURTHER PROCESSING
-Ibuprofen Directly compressible granules 66%POWDERDRUG FOR FURTHER PROCESSING
LISDEXAMFETAMINE DIMESYLATELISDEXAMFETAMINE DIMESYLATECAPSULEANDA
LISDEXAMFETAMINE DIMESYLATELISDEXAMFETAMINE DIMESYLATECAPSULEANDA
LISDEXAMFETAMINE DIMESYLATELISDEXAMFETAMINE DIMESYLATECAPSULEANDA
LISDEXAMFETAMINE DIMESYLATELISDEXAMFETAMINE DIMESYLATECAPSULEANDA
LISDEXAMFETAMINE DIMESYLATELISDEXAMFETAMINE DIMESYLATECAPSULEANDA
LISDEXAMFETAMINE DIMESYLATELISDEXAMFETAMINE DIMESYLATECAPSULEANDA
LISDEXAMFETAMINE DIMESYLATELISDEXAMFETAMINE DIMESYLATECAPSULEANDA
LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDELOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDETABLET, FILM COATEDANDA
LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDELOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDETABLET, FILM COATEDANDA
LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDELOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDETABLET, FILM COATEDANDA
-Lapatinib DitosylatePOWDERBULK INGREDIENT
-LevetiracetamPOWDERDRUG FOR FURTHER PROCESSING
LevetiracetamLevetiracetamTABLET, FILM COATEDANDA
LevetiracetamLevetiracetamTABLET, FILM COATEDANDA
LevetiracetamLevetiracetamTABLET, FILM COATEDANDA
LevetiracetamLevetiracetamTABLET, FILM COATEDANDA
-Levocetirizine dihydrochloridePOWDERBULK INGREDIENT
-LinagliptinPOWDERBULK INGREDIENT
Lisdexamfetamine dimesylateLisdexamfetamine dimesylateTABLET, CHEWABLEANDA
Lisdexamfetamine dimesylateLisdexamfetamine dimesylateTABLET, CHEWABLEANDA
Provenance

Facility and operations data from the FDA Drug Establishments Current Registration Site. Product data from the openFDA National Drug Code Directory. Patent and exclusivity data from the FDA Orange Book. Shortage data from the FDA drug shortage database. Contact details the FDA publishes for registered establishments are deliberately not reproduced here. This entry is compiled from public records and has not been claimed by the company.