Mikart
Mikart specializes in oral solid and non-sterile oral liquid dosage forms, offering comprehensive pharmaceutical services including drug development, manufacturing, packaging, and regulatory support with over 45 years of industry experience.
Services
Mikart offers an array of pharmaceutical services, catering to drug development, clinical trial supplies, regulatory support, manufacturing, packaging, and analytical needs. Their services cover both solid and liquid oral dosage forms, comprehensive packaging solutions, and full regulatory support. The company specializes in pediatric, geriatric, and controlled-substance dosage forms, and they provide specific solutions for swallowing and palatability issues.
History
Mikart has over 45 years of experience in the pharmaceutical industry. The company has continually expanded its capabilities to include a broad range of oral solid and non-sterile oral liquid dosage forms. Significant investments have been made in their Atlanta facility, enhancing manufacturing capabilities and adding new suites for liquids and suspensions.
Facilities
Mikart's state-of-the-art facility is located in Atlanta, occupying 234,000 sq. ft. It features independent HEPA-filtered HVAC systems and a custom-designed low humidity suite. The facility also includes over 100,000 cu. ft. of CII vault space and cages for CIII-V products. Their manufacturing capabilities have been enhanced with the addition of Fette® double-sided tablet presses, and they have a specialized suite for liquid oral drug product development.
Pharmaceutical Packaging Solutions
Mikart provides extensive pharmaceutical packaging services including blister packs, pouch/foil strip packs, cartoning/tray packaging, unit dose cups, and bottle filling. They offer customized clinical trial packaging services like child-resistant packaging, over-encapsulation, and placebo manufacturing. Additional capabilities include sachet filling for powdered products with varied packaging options.
Regulatory Compliance and Analytical Services
Mikart offers comprehensive in-house regulatory compliance solutions, including application compilation and submission in e-CTD format, application maintenance, and lifecycle support. Their analytical services encompass method development and validation, cleaning validation studies, and quality control which includes microbiology laboratories. Mikart is licensed by the DEA to handle Schedule I through V drug substances.