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Packaging Facilities

Vitane Contract Packaging Facilities

Vitane Contract Packaging is located within Vitane Pharmaceuticals 14,400 sq. ft in Congers, NY. The packaging facility houses the corporate offices, three large packaging areas, two bottle packaging lines, one blister packaging line and a large warehouse with three loading docks. Vitane Contract Packaging is operational six days a week and runs up to three shifts a day. The controlled environment areas adhere to the guidelines of the FDA. Our HEPA systems meet all temperature and humidity standards. We provide advanced inventory control and a materials management system that follows strict procedures and protocol. All controlled substances are secured, handled and stored in accordance with DEA regulations. The packaging facility is equipped with state-of-the-art packaging equipment and is secured with an alarm system and full-facility surveillance. Our highly educated team is trained for efficient production and on-time delivery for all orders.

Nutraceuticals Packaging Facility

Vitane Pharmaceuticals, Inc. is registered with the FDA as a “Nutraceuticals Packaging Facility”, FDA registration #14024551844, complying with the GMP standards coded in Title 21 CFR. Part 111, “Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements”.In addition, the company is also in compliance with the proposed “Dietary Supplement Health and Education Act of 1994” (DSHEA ACT OF 1994).

FDA Regulatory Pharmaceuticals Compliance

The company is also registered with the United States FDA as a Pharmaceutical Packaging facility, Pharmaceuticals Facility Establishment Identifier # 3009790403, in compliance with the more stringent standards of 21CFR. Part 210 and Part 211 “Current Good Manufacturing Practice for Finished Pharmaceuticals”.

New York State of Pharmacy Board as a Wholesaler/Re-packer of Drugs and/or Devices

The company has fully validated/IQ/OQ its Warehouse Temperature and Humidity mapping, HVAC, Air Compressor, and all the packaging line components, Bottle filling and Blister packing lines.One hundred and fifty eight (158) Standard Operating Procedures (SOPs) are in effect covering all aspects of the packaging operations, warehouse, quality assurance, training, validations, regulatory affairs, and human resources. All Vitane employees have completed the GMP trainings that are documented as part of the compliance program.

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