What Mikart does

Mikart is a U.S.-based contract development and manufacturing organization (CDMO) founded in 1975 in Atlanta, Georgia, specializing in oral solid and non-sterile oral liquid dosage forms across the full development-to-commercialization lifecycle. The company's platform spans pre-formulation and formulation development, non-GMP small-scale laboratory work (eight suites), analytical method development, GMP manufacturing (50L–4,000L liquids, controlled substance suites, pediatric/geriatric formats), and full-service packaging including bottle filling, blister, pouch/foil, cartoning, unit-dose cups, and DSCSA-compliant serialization via OPTEL and TraceLink. Differentiated capabilities include DEA Schedule I–V controlled substance licensing, licensed NanoTransformer™ (nanoformulation) and Microcoat™ (taste-masking) technology platforms, nitrogen-purged liquid/suspension suites, and 2023 DSCSA-compliant serialization.

Mikart serves virtual to mid-sized pharmaceutical and biotech companies requiring outsourced CMC and regulatory capabilities, as well as specialty use-cases in controlled substances (opioids, cannabinoids, psychedelics), pediatric and geriatric formulations, and liquid oral products for dysphagia and palatability-challenged populations. Customer engagements run from preclinical through commercial supply and are supported by a dedicated project manager model with direct CEO-level engagement at kickoff. GTM is direct enterprise sales via a business development team ([email protected]), supplemented by thought leadership (white papers, webinars, blog), industry events, PR/news wires, and organic social — there are no resellers, distributors, or marketplace channels.

The company has been PE-backed since 2018 (the Arteche family retained control for the prior 43 years), and the PE sponsor has driven a multi-year transformation from focused generic manufacturer to integrated CDMO with expanded capabilities. Recent milestones include a 50%+ expansion in oral solid dosage bottling capacity (operational startup Q4 2026), new executive headquarters at Cumberland Center II in Northwest Atlanta (ribbon cutting April 28, 2026), a strategic co-marketing partnership with Benuvia Operations (April 2026) for controlled substances and complex APIs, and the addition of nitrogen-purged liquid/suspension suites (October 2024). Revenue is generated through project-based, quote-priced contracts for development, manufacturing, analytical, regulatory, and packaging services across clinical and commercial stages.

Name

Mikart

Legal name

Mikart, LLC

Website

https://mikart.com

Company type

Private

Founded year

1975

Operating status

Operating

Headcount range

251–500 employees

Short description

Mikart is a U.S. CDMO specializing in oral solid and non-sterile oral liquid dosage forms, serving virtual to mid-sized pharma and biotech companies with DEA Schedule I–V controlled-substance capabilities, formulation development, GMP manufacturing, and DSCSA-compliant packaging from preclinical through commercial supply.

Ownership category

akta.pro rank

Product category

Pharmaceutical Contract Development and Manufacturing (CDMO)

NAICS

Pharmaceutical Preparation Manufacturing (325412), Pharmaceutical and Medicine Manufacturing (32541)

SIC

Pharmaceutical Preparations (2834)

akta.pro primary industry

Small-Molecule Drug Product (Solid/Oral/Parenteral) CDMO (HLAGABAB)

akta.pro secondary industries

Clinical Trial Material (CTM) Manufacturing & Supply CDMO (HLAGABAK), Drug Substance–Drug Product Integrated CDMO (HLAGABAG), GMP Scale-Up, Tech Transfer & Process Validation (PPQ) (HLAGAHAL)

Keywords

• Pharmaceutical contract manufacturing
• Oral solid dosage forms
• Controlled substance manufacturing
• Pharmaceutical development services
• Pharmaceutical packaging services

Headquarters

HQ city

Atlanta

HQ country

United States

HQ region

North America

Offices2 records

Markets served

GTM type

B2B

Offering type

Services

Cost components

Personnel, Operations, Supply Chain, Infrastructure, Technology or R&D, Marketing or Sales

Revenue model

1. Contract Development & Manufacturing (CDMO) Services: Mikart provides end-to-end pharmaceutical development and manufacturing services from pre-formulation through commercial-scale GMP production and serialized packaging. Revenue is generated through project-based contracts, service fees for formulation development, manufacturing runs, analytical testing, regulatory support, and packaging services. Pricing is quote-based given the bespoke nature of CDMO engagements.
2. Oral Solid & Liquid Dosage Manufacturing: Manufacturing revenue derived from commercial-scale production of oral solid (tablets, capsules) and non-sterile oral liquid (solutions, suspensions) dosage forms, including controlled substances (Schedule I–V) and pediatric/geriatric formulations.

Go-to-market motion2 records

Distribution channels2 records

Marketing channels8 records

Core offering

Mikart is a U.S.-based pharmaceutical Contract Development and Manufacturing Organization (CDMO) that provides end-to-end services spanning pre-formulation, formulation development, GMP manufacturing, analytical testing, regulatory support, and serialized packaging for oral solid dosage forms (tablets, capsules) and non-sterile oral liquid dosage forms (solutions, suspensions). The company holds DEA Schedule I–V licensing for controlled substance development and manufacturing, and serves virtual to mid-sized pharmaceutical and biotech companies from non-GMP early-phase development through commercial-scale GMP production.

Product overview

Mikart is a Contract Development and Manufacturing Organization (CDMO) founded in 1975, offering an integrated platform of pharmaceutical development, manufacturing, and packaging services. The company's core offering spans oral solid dosage forms (tablets, capsules, powder in bottle) and non-sterile oral liquid dosage forms (solutions, suspensions), with specialized capabilities in controlled substances (Schedule I-V DEA-licensed), pediatric formulations, and geriatric formulations. Mikart provides end-to-end services from non-GMP early-phase development through clinical trial supplies to commercial-scale GMP manufacturing, complemented by full-service packaging including bottle filling, unit dose cups, blister packaging, cartoning, pouch/foil strip packs, and serialization. The company operates nitrogen-purged liquid/suspension suites and recently expanded into a new Atlanta headquarters with over 50% increased bottling capacity. Key technology partnerships include Nano PharmaSolutions (NanoTransformer nanoformulation) and Fluid Pharma (Microcoat taste-masking coating technology).

Differentiator

Problem solved

Functional benefit

Products and services

• Pharmaceutical Development Services Comprehensive early-phase drug development services including pre-formulation, formulation development for pediatric and geriatric populations, pharmaceutical regulatory support, non-GMP small-scale laboratory, and analytical method development for pharmaceutical and biotech clients.
• Pharmaceutical Manufacturing GMP manufacturing of oral solid (tablets, capsules) and non-sterile oral liquid (solutions, suspensions) dosage forms from clinical trial supplies through commercial-scale production for pharmaceutical and biotech clients.
• Controlled Substances Manufacturing (CI–CV) DEA-licensed development and manufacturing of controlled substances across all schedules (Schedule I–V), including secure storage, handling, and cGMP-compliant manufacturing for controlled drug products such as opioids, cannabinoids, and psychedelics.
• Clinical Trial Supplies Manufacturing and packaging of clinical trial materials including clinical trial labeling, packaging, and manufacturing services for Phase I through Phase III clinical programs.
• Oral Solid Dosage Form Manufacturing GMP manufacturing of oral solid dosage forms including tablets, capsules, and powder-in-bottle formulations for pharmaceutical clients.
• Liquids and Suspensions Manufacturing Manufacturing of non-sterile oral liquid dosage forms including solutions and suspensions, with nitrogen-purged capability for oxidation-sensitive products and capacity ranging from 50L to 4,000L.
• Pharmaceutical Packaging Service Full-service pharmaceutical packaging including blister packaging, pouch/foil strip packs, cartoning/tray packaging, unit dose cups, bottle filling, and serialized packaging for commercial and clinical trial materials.
• Pharmaceutical Regulatory Support Regulatory affairs services supporting IND, NDA, ANDA, and 505(b)(2) submissions with FDA compliance and documentation practices.
• Analytical Method Development Phase-appropriate analytical method development and validation supporting pharmaceutical product release, stability testing, and shelf-life determination, compliant with FDA, CFR, and ICH guidelines.
• Non-GMP Small-Scale Laboratory Services Early-stage product development laboratory with 8 non-GMP suites for rapid prototyping, formulation feasibility studies, optimization, and process development prior to scale-up to GMP manufacturing.
• Serialization Services 2023 DSCSA-compliant serialization capabilities offering unit-level traceability and aggregation from lowest unit of sale to pallet using OPTEL equipment and TraceLink data management, including returned product verification.

Quantifiable outcome

• Seamless transition from non-GMP early-phase to GMP commercial manufacturing without development rework or delays.
• +2 more outcomes

Named customers5 records

Segments4 records

Ideal customer profiles4 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature8 records

Partnerships

Five partnerships are on record, tiered core and supporting.

• Benuvia Operations, LLCcoreGTM or Marketing Partner · 1 April 2026Strategic co-marketing partnership combining Mikart's formulation development and finished dose manufacturing capabilities with Benuvia's expertise in controlled substances, complex APIs, and psychedelics. Creates a unified U.S.-based CDMO offering spanning API development through finished drug product manufacturing. Jointly promotes services globally targeting controlled substances, cannabinoids, and emerging therapeutic categories. Includes coordinated industry events and customer outreach.
• Nano PharmaSolutionscoreTechnology or Integration · 1 January 2022Technology partnership licensing NanoTransformer™ platform for nanoformulation of poorly soluble drugs. Mikart uses this technology to produce clinical trial materials for clients with BCS Class II/IV compounds. The technology generates stable drug nanoparticles using no additives, enabling nano-granules suitable for preclinical oral gavage and first-in-human powder-in-capsule from a single formulation — accelerating timelines and reducing API requirements.
• Fluid PharmacoreTechnology or Integration · 1 January 2022Technology partnership licensing Microcoat™ technology for taste-masking and modified-release oral liquid formulations. Enables coating of very small particles (under 100 microns) without agglomeration — a significant manufacturing challenge overcome. Supports more stable suspension products, reconstitutable suspensions, ODTs, chewables, and other patient-friendly dosage forms for pediatric and geriatric populations.
• OPTELsupportingTechnology or Integration · 1 January 2015Serialization equipment provider contracted to implement DSCSA-compliant serialization on Mikart's packaging lines. OPTEL provides hardware and integration services enabling unit-level traceability from manufacturing through distribution.
• TraceLinksupportingTechnology or Integration · 1 January 2015Serialized data management and verification platform contracted to manage and verify serialized product data, enabling DSCSA compliance, aggregation tracking, and EPCIS event data generation for Mikart's customers.

Scale indicators7 records

Recent moves6 records

Expansion highlights4 records

Emerging players

• Quotient Sciences: Quotient Sciences offers integrated drug development services including formulation and clinical manufacturing, with particular strength in early-phase and poorly soluble API work. Overlaps with Mikart's NanoTransformer-enabled preclinical-to-first-in-human platform and rapid early-phase formulation cycles.

Direct peers

• Tapemark: Tapemark is a contract manufacturer specializing in transdermal patches, unit-dose liquids, and other specialty dose forms for pharma, with packaging capabilities including serialization — a direct peer for Mikart's liquids/suspensions manufacturing and serialized packaging business.
• Adare Pharma Solutions: Adare is a CDMO with deep pediatric and geriatric formulation expertise, taste-masking technology, and oral solid/liquid manufacturing — directly comparable to Mikart's Microcoat-enabled taste-masking for pediatric/geriatric populations.
• Particle Sciences (Lubrizol): Particle Sciences (acquired by Lubrizol Life Science) is a CDMO specializing in complex drug formulations including nanoformulations, controlled substances, and patient-centric dosage forms — a strong analog to Mikart's poorly-soluble API and specialty controlled-substance capabilities.
• CoreRx: CoreRx is a mid-sized U.S. CDMO specializing in liquid and solid oral dose forms, controlled substances, and complex formulation development — directly comparable to Mikart in customer base (virtual-to-mid pharma), technology stack, and dosage form focus.
• Halo Pharma: Halo Pharma is a mid-sized CDMO offering oral solid and liquid dose manufacturing, pediatric formulations, and small-mid pharma focused commercial supply — competing head-to-head with Mikart on dosage forms and customer profile.
• Ascendia Pharmaceuticals: Ascendia is a specialty CDMO focused on complex formulations, poorly soluble APIs, and small-batch injectable and oral dose manufacturing for niche pharma clients — overlapping closely with Mikart's NanoTransformer-enabled solubility work and small-mid pharma target market.

Broad incumbents

• Hovione: Hovione is a global CDMO with strengths in API and drug product development including oral solids and complex formulations. Overlaps with Mikart's integrated API–drug-product development capabilities and complex formulation technology.
• PCI Pharma Services: PCI is a global integrated CDMO with strong commercial packaging, serialization, and oral solid dose capabilities. Overlaps with Mikart on serialization/DSCSA services and commercial bottling scale, but operates at significantly larger scale across multiple modalities.
• Catalent Pharma Solutions: Catalent is a global, broad-portfolio CDMO serving oral solid, sterile, biologics, and specialty dose forms across large and small pharma. Comparable as a broader incumbent CDMO with overlap in oral solid dose manufacturing and clinical-to-commercial supply.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat5 records

Key risks5 records

Key highlights7 records

Customer concentration

• LinkedInlinkedin.com/company/mikart-llc

Revenue estimate

Valuation estimate

Number of profiles

Profiles5 records

Funding overview

Funding rounds

Investors

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about Mikart