Catalent

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Manufacturer
Audited
Audit report available

Headquarters

Flag of United States of AmericaUnited States of America

Sites

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Products & Services

3 3'-diindolylmethane

Abiraterone Acetate

Accutane 10mg 40mg

Acetaminophen

Acyclovir

Advil Cold and Sinus Liquid Gels

Advil Liqui-Gels 200 mg

Advil PM Liqui-Gels

Alectinib

Amifampridine Phosphate

Amprenavir

Amprenavir 50 and 150 mg Soft Gelatin Capsules

AMR 101 1G Capsules

Analytical Method Development and Validation

Analytical Testing for Inhalation Products

Anastrozole

Ansuvimab

Apixaban

Atazanavir Sulfate

Atrasentan

Atrasentan hydrochloride soft gelatin capsules 10 mg (base equivalent)

Belumosudil

Bendroflumethiazide

Benzonatate

Bexarotene

Bioavailability Enhancement Technologies

Biological Drug Products

Borhyaluronidase alpha (genetical recombination)

Country

Flag of United States of AmericaUnited States of America
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Catalent Indiana

Country

Flag of United States of AmericaUnited States of America

City

Bloomington

Address

South Patterson Drive 1300, 47403 4828

Caffeine Ergotamine

Calcifediol

Calcitriol

Calcitriol 0.25 mcg Soft Gelatin Capsules

Calderol Softgels 20mcg

Capsule Development and Manufacturing Services

Clinical Logistics Solutions

Clinical Manufacturing for Oral Liquids

Clinical Packaging Blister

Clinical Packaging - HDPE Bottles

Clinical Packaging & Labeling

Clinical Storage & Distribution

Clonidine

Codicaps

Country

Flag of GermanyGermany
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Audit report appendices available
Audit report available

Catalent Germany Eberbach GmbH

Country

Flag of GermanyGermany

City

Eberbach

Address

Gammelsbacher Straße 2, 69412

This audit report also includes the following appended documentation:

  • List of SOP
  • Site master file

Contract Manufacturing for Nasal Dosage Forms

Contract Manufacturing for Nasal Spray

Contract Micronization Facility in Exton PA

Contract Micronization Facility in Kent, United Kingdom

Controlled Release Technologies

Controlled Substance Oral Solid Manufacturing

Cyclosporine

Dantrolene Sodium

Deslorelin Acetate

Device Evaluation and Selection

Doxercalciferol

Doxycycline

Drisdol Softgels (Ergocalciferol 50,000 IU)

Dronabinol Capsules USP 2.5mg 5.0mg 10.0mg (CIII) SA

Dry Powder Inhalers (DPIs)

Dutasteride

Dutasteride 0.5 mg soft gelatin capsules

Dutasteride Soft Gelatin Capsules 0.5mg

Efavirenz

Erythromycin

Estradiol Vaginal Soft Gelatin Capsules

Ethosuximide

Exemestane

Felbamate

Fentanyl

Fluorouracil

Formulation Development for Capsules

Formulation Development for Clinical Supply

Formulation Development for Tablets

Formulation Development of Inhaled Products

Hectorol 2.5 mcg 1.0 mcg and 0.5 mcg capsules

Highly Potent Capsules

Highly Potent Tablets

Hot Melt Extrusion

Hyaluronidase

Hytrin (Terazosin) Soft Gelatin Capsules

Ibrutinib

Ibuprofen

Ibuprofen Softgels 200 mg

Icosapent Ethyl Gel Capsule 1000 mg (120 count bottle)

Country

Flag of United States of AmericaUnited States of America
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Audit report available

Catalent Greenville

Country

Flag of United States of AmericaUnited States of America

City

Greenville

Address

Sugg Parkway 1240, 27834

Icosapent Ethyl Gel Capsule 500 mg (240 count bottle)

Country

Flag of United States of AmericaUnited States of America
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Audit report available

Catalent Greenville

Country

Flag of United States of AmericaUnited States of America

City

Greenville

Address

Sugg Parkway 1240, 27834

Immediate and Sustained Release Capsules

Immediate and Sustained Release Formulations

Immediate and Sustained Release Tablets

Injectable Drug Product Manufacturing

Injectable Filling and Packaging in Cartridges

Isotretinoin

Isradipine

Lanoxicaps 0.5 0.10 and 0.20mg Softgel Capsules

Letrozole

Levalbuterol Tartrate

Lipid Based Drug Delivery

Lopinavir

Lopinavir/ritonavir 133.3/33.3mg soft gelatin capsules

Loratadine

Loratadine Softgels 10 mg

Lovaza 1 g Soft Gelatin Capsules (Omega-3-Acid Ethyl Esters, 1 Gram)

Lubiprostone

Lubiprostone 24mcg capsules

MDV3100 40mg capsules (softgels)

Miconazole

Miconazole 1200 mg Softgels

Miconazole Gelatin Encapsulated Vaginal Suppository 200 mg

Miconazole Nitrate

Miconazole Nitrate 1200mg Vaginal Ovule Soft Gelatin Capsule

Micronization of Highly Potent Compounds

Micronization Process Facility

Mifepristone

Morphine Sulfate

Nasal Solution and Suspension

Nasal Spray Clinical Supply

Neomycin Sulfate

Neoral 25 mg and 100 mg softgels

Nepafenac

Nifedipine

Nifedipine 10mg and 20mg Softgel Capsule

Nimodipine

Nimodipine 30mg Softgel Capsules

Nimodipine 30mg Softgels

Nitazoxanide

Omega-3 Acid Ethyl Esters 90

Oral Dose Technologies

Oxycodone

Oxycodone Hydrochloride

Palonosetron

Palonosetron HCl 0.50 mg softgels (1.5 oval)

Palonosetron Hydrochloride 0.50 mg Softgels

Palovarotene

Paricalcitol

Pharmaceutical Contract Micronization

Phenoxybenzamine Hydrochloride

Pilocarpine

Procardia Softgels 10 mg (Nifedipine)

Progesterone

Progesterone Soft Gelatin Capsules 100 mg and 200 mg

Promethazine Hydrochloride

Prometrium 100 mg and 200 mg soft gelatin capsule

R115866 Softgels

Regulatory Support Services

Risperidone

Risperidone 0.5 mg and 1.0 mg Orally Disintegrating Tablets

Risperidone 2.0 mg orally disintegrating tablets

Ritonavir

Ritonavir 100mg and 200mg Soft Gelatin Capsule

Rocaltrol 0.25mcg & 0.5mcg Softgel Capsule

Sandimmun 25 mg and 100 mg softgels

Scale Up and Technology Transfer

Scale-Up Capabilities

Secnidazole

Secondary Packaging Services

Selegiline Hydrochloride

Selegiline Hydrochloride Zydis Tablet 1.25mg

Soft Gelatin Capsule Manufacturing Process for OET-10275167

Soft Gelatin Capsule Oet 10275258

Softgel Development & Manufacturing Services

Softgels Oet 10258977

Softgels OET10275261

Softgels Oet 10275378

Softgels Oet 10275449 50

Softgels Oet 10275485

Softgels OET-10275547-9

Sotorasib

Spray Drying Solutions

Stick Packs for Powder, Granule & Gel

Tablet Development and Manufacturing Services

Tafamidis

Talarozole

Targretin 75 mg Soft Gelatin Capsule

Terazosin HCl

Tessalon 100 mg and 200 mg Softgel Capsules and Benzonatate 100 mg and 200 mg Softgel Capsules

Tipranavir

Tipranavir capsules 250 mg imprinted

Tretinoin

Vandetanib

Vesanoid 10mg Softgels

Vial Filling and Packaging

Vigabatrin

Vitamin D

Yxsoralen Ultra Soft Gelatin Capsules

Zarontin 0.25g Soft Gelatin Capsules

Zemplar (paracalcitol) capsules, 1 mcg

Zydis Fast Dissolving Tablet Technology