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ANI GLOBAL SOURCE IS A CULTURE OF INTEGRITY

Manufacturing & Packaging


ANI Global Source, we produce solid, semi-solid and non-sterile liquid products.

From Phase IIB through commercial manufacturing, ANI Global Source manufactures and packages a wide variety of dosage forms including tablets, capsules, liquid unit dose, liquid solutions, suspensions, topical liquids, creams, and gels.  We have world-class facilities, experienced operators and a comprehensive set of equipment to get started on your program.

Clinical

We have clinical manufacturing capabilities for all of our dosage forms.  Our typical entry point for clinical manufacturing is typically Phase 2B.  If you have a clinical manufacturing program we would like to talk to you and if you would like to know more about our development capabilities please follow this link.

Commercial

As your contract manufacturing partner, ANI Global Source is dedicated to fast, flexible, seamless commercial manufacturing processes that enable a competitive advantage for our clients. Built on a culture of excellence with a 40+ year history, ANI Global Source continues to pioneer new methods that maximize quality and optimize time to market.

Manufacturing Capability Matrix

Finished Dosage Form Development Typical Batch Size (range) Capacity
Oral tablets - active Yes 90 - 450 kg ~3.5 billion doses/yr
Oral tablets - placebo Yes 90 - 450 kg  
Capsules - active Yes 200 - 500 kg ~490 million doses/yr
Capsules - placebo Yes 200 - 500 kg  
Over encapsulation Yes 10 - 25 kg  
Overcoating - Aqueous Yes 100-200 kg  
Overcoating - Solvent Yes 100-175 kg  
Liquid fills Yes 1000 - 2000L ~56 million bottles/yr
Liquid fills - Unit Dose Yes 60 - 2000L 12 million/cups/yr
Topicals Yes 360-500 kg ~2 million tubes/yr
Powder Fill Yes 100 - 1000kg ~12 million bottles/yr
Fluid bed granulation Yes    
Hi-shear wet granulation Yes    
Direct tablet compression Yes    

 

Packaging One of the key benefits of our manufacturing capability is our ability to support packaging for all of the dosage forms that we manufacture. Bottles, blisters, and tubes are all at your disposal for a comprehensive manufacturing partner. Serialization ANI Global source has implemented serialization and is well on our way to be compliant with serialization requirements. Please contact us for more information.

 

Packaging Matrix Mass Configurations Size/Shape Materials
Solids Packaging: Bottles        
Tablets 100 - 1050 mg 12, 100, 250,
500, 1000
Round, Capsule, Elliptical  
Capsules 100 - 600 mg 100, 250,
500, 1000
00,0,1,2,3,4  
Powder Fill 3-2000 g 1 - 5" diameter containers Round Containers  
Solids Packaging: Blisters   4, 7, 10 Card Base: PVC, PVC/PVDC,
ALCAR, PETG,
Polypropylene, Fromable Foils
        Lidding: Al lined with PVDC
or heat sealable lacquer,
Tyvek, Paper coated
with sealable lacquer
Solids Packaging: Blisters 3 - 1000 mL Bottle Round, Square Plastic, Glass
Liquid Packaging-Unit Dose 5 - 30 mL Cup square unit dose cups Plastic
Semi-Solid Packaging 2 - 227 g Tube Plastic, Laminate, Metal  

Facilities & Equipment
Specialized Product  Manufacturing Capabilities
Manufacturing & Packaging
Analytical Services
Formulation Development
Technology Transfer