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Hubot, Inc. CDMO

Hubot, Inc. CDMO

Company Headquarters

3333 North Kenmore Street, , South Bend, IN, 46628, US

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Company Description

Hubot, Inc. is a full-service CDMO with deep expertise in the development and commercial manufacturing of complex dosage forms including aerosols, bag-on-valve systems, liquids, suppositories, foams, gels, pastes, and tubes. Serving Consumer Healthcare (OTC, Rx), Medical Device, and Prestige Beauty customers, Hubot combines rigorous pharmaceutical-grade quality systems with the agility of an innovation-focused partner. Our South Bend, Indiana facilities feature ISO 7 and ISO 8 cleanroom environments, a dedicated USP RO-EDI water system, and on-site analytical and innovation labs built to support customers from concept through commercial scale. Our quality framework is validated by a comprehensive certification portfolio including ISO 13485, ISO 22716, ISO 9001, ISO 14001, UL FDA GMP, UL Retailer, Health Canada, and EcoVadis, with facility operations governed by US FDA, EPA, ITAR, Health Canada, and REACH standards.

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Categories from Hubot, Inc. CDMO

505(b)(2)
Accelerated Stability Studies
Aerosol Filling
Analytical Laboratory Services
Analytical Methods Development
Analytical Validation Studies
Animal Health
Assay Development
Chemical Analysis
Chemicals and Raw Materials
Chromatographic Analysis, LC/GC
Consulting
Consulting, Process Analytical Technology (PAT)
Contract Development and Manufacturing Organization (CDMO)
Contract Manufacturing
Contract Packaging
Contract Research
Drug Delivery Systems
Drug Development Services
Efficacy Testing
Extractables / Leachables Testing
Formulation Development
Formulation Services
GMP Auditing
HPLC
IT, 21CFR11 / Annex 11
Lot Release Testing
Manufacturing, Aerosol
Manufacturing, Clinical Trials Supply
Manufacturing, Creams & Ointments
Manufacturing, Dose Form, Non-Sterile
Manufacturing, Gels
Manufacturing, Liquids
Manufacturing, Nasal Delivery
Manufacturing, Nutraceuticals
Manufacturing, Ophthalmics
Manufacturing, Oral Drug Delivery
Manufacturing, OTC
Manufacturing, Powders, Non-Sterile
Manufacturing, Semisolids
Manufacturing, Solutions & Suspensions
Manufacturing, Suppositories
Manufacturing, Topicals
Manufacturing, Veterinary
Methods Development
Methods Validation
Microbial
Microbiological Control Services
Microbiological Testing
Mixing & Blending
Packaging, Compliance
Packaging, Creams & Ointments
Packaging, Design & Testing
Packaging, Development
Packaging, Liquids
Packaging, OTC
Packaging, Private Labeling
Packaging, Services, Other
Process Development/Scale-Up Services
Process R&D
Process Validation Studies
QA/QC
Quality Control Testing
R&D Services
Raw Materials Analysis
Regulatory Affairs Consultants
Scale-Up
Serialization
Stability Studies
Stability, ICH
Validation, Equipment Cleaning
Validation, Manufacturing
Warehousing
Water Treatment Consulting
Wet Chemical Analysis

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