• Technical expertise – Knowhow, experience and capability.
• Regulatory status – In good standing with the FDA.
• Regulatory filing experience.
• PAI – Product developed in USA according to cGMP, inspection on same site and Subject Matter Experts (SMEs) available.
• Any issues with equipment can be addressed immediately.
• USA filing from USA manufacturer.
• Can be transferred after approval to any site in the world.

Capabilities

• Tablet / Capsule formulation development
• Analytical support (HPLC, UPLC, GC, ICP-MS, etc.)
• Capsule >50,000 capsules/hr
• Tablets 66,000- 528,000 tablets/hr (double sided, 55 station, Kikusui)
• Prototype batches for stability, regulatory submissions or clinical trials (10,000 – 150,000 dosages)
• Commercial batches (50k – 5M+ dosages/batch)
• State of the Art packaging lines: In house finished
  products bottling and packaging