Mikart, LLC
1750 Chattahoochee Ave NW
Atlanta, GA 30318
W: http://www.mikart.com

COMPANY DESCRIPTION

Mikart’s 45+ years of experience in oral solid and nonsterile oral liquid dosage forms and specialization in pediatric, geriatric, and controlled-substance make us the ideal contract development and manufacturing organization partner — from formulation development through commercialization. We value long-lasting relationships and a personalized approach; bringing both the reliability and flexibility to meet your needs and exceed your expectations. For the solid foundation and flexible solutions to bring your product to life, choose Mikart.

SERVICES & CAPABILITIES

Mikart specializes in pharmaceutical contract development and manufacturing. Their expertise lies in providing comprehensive solutions for formulation development, manufacturing, packaging, and regulatory support for various dosage forms, including solid oral dosage, liquids, semi-solids, and more. They excel in tailored drug delivery technologies, process optimization, and ensuring compliance with industry regulations, positioning themselves as a reliable partner for companies aiming to bring innovative pharmaceutical products to market.

TECHNOLOGIES

Mikart offers an extensive range of solutions that empower clients to excel in their endeavors. Poor solubility remains one of the greatest challenges in pharmaceutical development. Mikart has exclusive partnerships with Nano PharmaSolutions’s proprietary NanoTransformer™, a scalable nanosizing technology that generates drug nanoparticles in the 200-600nm (D50) range, and Fluid Pharma, a licensing and product development company applying its proprietary MicroCoat™ technology to advance new therapies for pediatric, geriatric, and oral liquid modified-release applications.

Mikart’s technologies enable clients to navigate complexities, expedite timelines, and achieve success in bringing novel therapies to market efficiently and effectively.

FACILITIES

Mikart has a campus in the Atlanta, GA, staffed by 200+ employees. Our 150,000 sq ft facilities in Atlanta, GA can provide development-scale through commercial-scale production. The facility boasts cutting-edge equipment and technologies for pharmaceutical development and manufacturing across various dosage forms. It includes specialized areas for formulation development, analytical laboratories, multiple manufacturing suites equipped for different types of drug products, packaging capabilities, and storage areas compliant with industry standards and regulatory requirements. Mikart’s facility is designed to accommodate the diverse needs of our clients in the pharmaceutical industry.

MIKART EXPERTISE

• Controlled Substances, including Class 1 Psychedelics
• Pediatric formulations
• Geriatric formulations
• Liquid oral solid dose, solutions & suspensions
  – Tablets
  – Capsules
• Oral liquid dose

AREAS OF EXPERTISE

• Pre-formulation
• Formulation development
• Analytical method development
• Regulatory support
• Process optimization
• Scale-up
• Site and technology transfers
• Product application support

PROCESSING CAPABILITIES

• Delayed release film coating
• Direct compression
• Fast dissolve (ODT)
• Fluid bed top spray
• High shear wet granulation
• Immediate release film coating
• Liquid-to-solid conversion
• Low humidity manufacturing
• Low shear wet granulation
• Modified release film coating
• Multiple unit pellet system

DEDICATED DOSAGE FORMS

• Solutions and Suspensions
• Chewable/ODT
• Liquids/suspensions
• Minitabs
• DEA Controlled substances:
  – Manufacturing: Schedules 1-V
• High Potency

ANALYTICAL SERVICES

• Analytical method development and analytical method validation
• Cleaning validation studies
• Contract resources for specialty analyses
• DEA schedule I-V materials
• Drug release profiles (apparatus I and II)
• HPLC, UPLC, AA, FTIR, UV-Vis, and more
• Method transfer
• Quality control and microbiology laboratories
• Thermal cycling studies
• Verification of USP methods
• Whole and split tablet studies

COMPREHENSIVE PACKAGING CAPABILITIES

State-of-the-art packaging facility with 6 packaging lines with full serialization that can fill over 250,000 bottles per day. Packaging includes bottle filling, blistering, pouch/foil strip packs, cartoning and tray packaging, unit dose cups, and sachet. All of Mikart’s packaging lines are contained in individual suites with independent HVAC systems.