Herbal, Vitamin & Dietary Supplement Contract Manufacturing

Facility and Technical Services

Labeler Our FDA registered cGMP facility has over 25,000 square feet of state-of-the-art capability, with current capacity for tablet and capsule manufacturing exceeding 1 million per month. Vesta's commitment to quality is exemplified by our onsite, full service quality control lab. cGMP requirements include: complete compendia testing for RM's; analytical method validation; manufacturing process validation; cleaning validation; and annual product review. Vesta's equipment inventory includes a chemistry laboratory outfitted with a fume-hood, pH meter, two spectrophotometers, two High Performance Liquid Chromatography (HPLC) systems, and various testing, measuring, and weighing equipment competent for testing material quality. Our manufacturing capabilities are enhanced by: a Littleford plow style granulator and ribbon blender for granulation; Fitzmill and Quadro Comil sizing equipment; Double cone (10ft3 and 100ft3) and Twin Shells (16 quart and 30ft3) units for blending; Manesty Beta press, Manesty Versa press and a Fette P2000 for compression; a 24 inch Accela Cota for coating; and full packaging capabilities of 12,000-18,000 bottles/day.

Formulation and Process Development

Blending, drying, granulation and coating development
Brand extension formulation development
Dosage form specification development
Excipient compatibility studies
Excipient selection and ration determination
Formulation of drug products: solids and semi-solids
Immediate release dosage form development
Manufacturing process optimization
Modified and sustained release dosage form development

Formulation Evaluation

Compressibility evaluation
Content uniformity evaluation
Disintegration testing
Dissolution testing
Friability testing
In-vitro bioequivalence determination
Powder flow determination
Stability assessment
Tap-density testing

Clinical and Small to Large Commercial
Manufacturing and Small Scale Phase III

cGMP Manufacturing
Dosage form preparation and blending
Granulation, tableting, encapsulation and coating
Open and blended clinical packaging and labeling
Semi-automated encapsulation and coating

Regulatory Support & Consulting

Facility & Process Validation

Analytical Method Development/Validation

Development and validation of analytical methods in support of stability testing of drug substances and drug products, residual solvent testing and cleaning validation testing.

Raw Material/Excipient Testing

Testing performed according to the USP, EP, BP, JP or FCC Compendia, or performed according to client-supplied or vendor-supplied methods.

Stability Testing and Stability Storage

Testing performed to support national and international regulatory submissions for new products.' Commercial product stability programs also supported.' Stability storage capabilities with a broad range of storage conditions including all ICH conditions for long-term or accelerated stability studies as well as photostability studies.

Comparative Product Testing

Development and validation of assay, impurity and dissolution methods for over-encapsulated and/or de-branded marketed products.
Testing performed to support clinical release, clinical re-assay and stability programs.

Marketed Product Release Testing

QA/QC release testing performed to support marketed products.

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