American Botanical Drug Corporation

GMP Manufacturing

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ABDC utilizes already established GMP manufacturing facilities in the US and in Asia for cost-effective botanical product GMP manufacturing services:

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• Scale up from R&D to cGMP manufacturing

• Technology transfer

• Drug development process

• Formulation optimization

• Clinical trial materials GMP manufacturing

• Pharmaceutical products manufacturing

• Release testing

• Certificates of Analysis

• Formal stability studies according to ICH guidelines

• Commercial product manufacturing

Clinical Supply Manufacturing

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Packaging and labeling for:

• Sterile fill syringes

• Bottles

• Over encapsulation

• Blister packaging

• Bulk packaging

• Bulk labeling

• Sachets

• Powder in bottle

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Pharmaceutical product dosage forms:

• Capsules, hard gelatin or HPMC (hydroxypropyl methyl cellulose), liquid-filled

• Capsules, hard gelatin or HPMC, powder-filled

• Capsules, controlled or sustained release

• Tablets, immediate release

• Tablets, controlled or sustained release

• Tablets, enteric-coated

• Topical gels, creams, ointments

• Oral liquids

• Over-encapsulation

• Injectables, including lyophilization