INCOG BioPharma
INCOG BioPharma is a privately held sterile injectable CDMO providing end-to-end fill/finish, device assembly, and packaging services for clinical through commercial phase drug products. It serves global market-leading biopharmaceutical companies from its FDA-approved, Annex 1-compliant 21-acre campus in Fishers, Indiana.
- Company typePrivate
- Founded2021
- HeadquartersFishers, United States
- Headcount101–250
- GTM typeB2B
- OfferingServices
What INCOG BioPharma does
INCOG BioPharma is a privately held contract development and manufacturing organization (CDMO) specializing in sterile injectable drug product fill/finish services for the global biopharmaceutical market. Founded in 2021 and headquartered in Fishers, Indiana, the company operates from a 21-acre, FDA-approved, Annex 1-compliant purpose-built campus featuring barrier isolation filling technology, OPTIMA MultiUse L6000 filling lines, AES Clean Technology modular cleanrooms, and capabilities across syringes (0.5–10mL), cartridges (1.5–5mL), and vials (2R–30R). Its integrated service portfolio spans formulation development, aseptic filling, analytical method development, device assembly and packaging for combination products (autoinjectors, pens, needle safety devices), and regulatory/compliance support for clinical through commercial phase programs.
The company targets market-leading biopharmaceutical companies for long-term strategic partnerships, engaging enterprise decision-makers via direct sales and major industry conferences such as BIO International, PDA Universe of Pre-filled Syringes, CPHI, INTERPHEX, DCAT, and the J.P. Morgan Healthcare Conference. Revenue is generated through project-based fee-for-service contracts covering clinical and commercial sterile injectable manufacturing. Following its first FDA commercial approval in 2024 with zero Form 483 observations, INCOG is executing a $200 million campus expansion announced in December 2025 that will add approximately 300,000 ft², scale annual fill capacity to 480 million units, and grow the workforce to nearly 1,000 employees by 2030.
Leadership is concentrated among co-founder Cory Lewis (CEO/President), co-founder Tedd Green (COO), and CFO Doug Dayhoff, supported by VPs of Quality, Technical Operations, Operations, and Business Development. The company is founder-owned with no disclosed institutional private equity backing, has raised approximately $86.6M in disclosed funding across 2020, 2022, and 2024 rounds, and is growing through a combination of operating cash flow, prior capital raises, and the $200M expansion investment. INCOG has been named one of Indiana's Best Places to Work for four consecutive years (2022–2025).
INCOG BioPharma firmographics
Firmographics- Name
- INCOG BioPharma
- Legal name
- INCOG BioPharma Services, Inc.
- Website
- https://incogbiopharma.com
- Company type
- Private
- Founded year
- 2021
- Operating status
- Operating
- Headcount range
- 101–250 employees
- Short description
- INCOG BioPharma is a privately held sterile injectable CDMO providing end-to-end fill/finish, device assembly, and packaging services for clinical through commercial phase drug products. It serves global market-leading biopharmaceutical companies from its FDA-approved, Annex 1-compliant 21-acre campus in Fishers, Indiana.
- Ownership category
- akta.pro rank
INCOG BioPharma industry classification
Industry- Product category
- Contract Development and Manufacturing (CDMO) Services for Sterile Injectables
- NAICS
- Pharmaceutical Preparation Manufacturing (325412), Pharmaceutical and Medicine Manufacturing (32541)
- SIC
- Services-Commercial Physical & Biological Research (8731)
- akta.pro primary industry
- Sterile Fill-Finish & Aseptic Manufacturing CDMO (HLAGABAH)
- akta.pro secondary industries
- Drug Substance–Drug Product Integrated CDMO (HLAGABAG), Process Development & Tech Transfer Services (CDMO) (HLAGABAL)
Keywords
Where INCOG BioPharma is headquartered
LocationHeadquarters
- HQ city
- Fishers
- HQ country
- United States
- HQ region
- North America
Offices1 record
Markets served
INCOG BioPharma business model
Business model- GTM type
- B2B
- Offering type
- Services
- Cost components
- Personnel, Operations, Infrastructure, Technology or R&D, Marketing or Sales, Supply Chain
Revenue model
- Contract Manufacturing Services: INCOG operates as a Contract Development and Manufacturing Organization (CDMO) providing fee-for-service manufacturing to biopharmaceutical companies. Revenue is generated through project-based contracts for sterile injectable fill/finish services spanning clinical through commercial phases.
Go-to-market motion2 records
Distribution channels1 record
Marketing channels5 records
INCOG BioPharma product offering
Product offeringCore offering
INCOG BioPharma is a fill/finish Contract Development and Manufacturing Organization (CDMO) providing end-to-end sterile injectable drug product manufacturing services from clinical through commercial phases. Its offering includes aseptic formulation and filling of syringes, cartridges, and vials using barrier isolation technology; automated device assembly and packaging for combination products; and support services such as QC testing, process scale-up, regulatory support, and material storage. Services are delivered from a 21-acre, FDA-approved and Annex 1-compliant campus in Fishers, Indiana.
Product overview
INCOG BioPharma is a fill/finish Contract Development and Manufacturing Organization (CDMO) providing end-to-end solutions for clinical through commercial phase sterile injectable drug products for the global biopharmaceutical market. The company's core offering consists of three integrated service areas: (1) Formulation and Filling Services using barrier isolation technology for syringes, cartridges, and vials at clinical and commercial scale; (2) Device Assembly & Packaging for combination products including autoinjectors and pen injectors with full serialization and track-and-trace capabilities; and (3) Support Services including quality control testing, regulatory support, and material storage. The company operates from a 21-acre campus in Fishers, Indiana, featuring FDA-approved, Annex 1-compliant facilities with multiple OPTIMA filling lines.
Differentiator
Problem solved
Functional benefit
Products and services
- Formulation and Filling Services Aseptic fill/finish services for clinical through commercial scale manufacturing, handling syringes (0.5mL to 10mL), cartridges (1.5mL to 5mL), and vials (2R to 30R) using barrier isolation filling technology with time pressure or peristaltic pump mechanisms and non-destructive inline weight verification. Offered to biopharmaceutical companies requiring sterile injectable manufacturing.
- Device Assembly & Packaging Automated assembly of complex combination products including autoinjectors (YpsoMate by Ypsomed, Molly by SHL Medical), pens, safety systems (BD UltraSafe Plus), and needle safety devices, with precision labeling, unit-dose serialization, and custom packaging configurations. Targeted at biopharmaceutical companies launching injectable combination products.
- Support Services Comprehensive support including process design and scale-up, QC chemistry and microbiology testing, regulatory support and compliance, and material and finished product storage. Laboratory services include formulation and analytical development for clinical and commercial scale-up. Available to biopharmaceutical clients as part of INCOG's end-to-end CDMO offering.
- Sterile Injectable Drug Product CDMO Services End-to-end contract development and manufacturing organization services for sterile injectable drug products spanning clinical through commercial phases, integrating formulation, aseptic filling, analytical development, regulatory support, and final packaging. Offered to global biopharmaceutical companies.
Quantifiable outcome
- Production capacity of 480 million units annually post-expansion
- +2 more outcomes
Companies that use INCOG BioPharma
Customer profileNamed customers1 record
Segments1 record
Ideal customer profiles1 record
INCOG BioPharma technology and API
TechnologyTechnology focussed No
API detail
- Has API
- No
- API docs
- API detail
Core technology
AI maturity
App detail
Feature6 records
INCOG BioPharma partnerships and signals
Strategic signalPartnerships
Four partnerships are on record, tiered core and supporting.
- AES Clean TechnologycoreAES Clean Technology equipped INCOG's state-of-the-art facility in Fishers with its modular cleanroom systems and high-performance HVAC technology to optimize environmental control. The partnership provided the flexibility and customization for growth, including the ability to quickly triple drug product manufacturing capacity via future capital investment projects.
- OPTIMA PharmacoreOPTIMA Pharma provided the filling line equipment for INCOG's manufacturing facility. The OPTIMA MultiUse L6000 filling line drives up to 40M units of annual capacity for pre-filled syringes, cartridges, and vials and was cGMP qualified with its first media fill campaign.
- Shiel SextonsupportingConstruction partner for the facility build-out, contributing to the rapid construction timeline that saw INCOG break ground and complete state-of-the-art build-out in under a year.
- Javan EngineeringsupportingEngineering partner contributing to the facility design and construction for INCOG's cleanroom production area.
Scale indicators7 records
Recent moves9 records
Expansion highlights6 records
INCOG BioPharma competitors and assessment
Company assessmentMarket position
Competitive moat4 records
Key highlights6 records
Customer concentration
INCOG BioPharma social profiles
Digital presenceINCOG BioPharma financial estimates
Financial estimateRevenue estimate
Valuation estimate
INCOG BioPharma leadership team
Management profileNumber of profiles
Profiles7 records
INCOG BioPharma funding detail
Funding detailFunding overview
Funding rounds5 records
Investors
Funding detail is available on the Subscription and Enterprise plan.Contact sales →
INCOG BioPharma M&A and investment
M&A and investmentM&A
Investments
M&A and investment is available on the Subscription and Enterprise plan.Contact sales →
Frequently asked questions about INCOG BioPharma
What does INCOG BioPharma do?
INCOG BioPharma is a fill/finish Contract Development and Manufacturing Organization (CDMO) providing end-to-end sterile injectable drug product manufacturing services from clinical through commercial phases. Its offering includes aseptic formulation and filling of syringes, cartridges, and vials using barrier isolation technology; automated device assembly and packaging for combination products; and support services such as QC testing, process scale-up, regulatory support, and material storage. Services are delivered from a 21-acre, FDA-approved and Annex 1-compliant campus in Fishers, Indiana.
Is INCOG BioPharma a public or private company?
INCOG BioPharma is a private company. It is classified as founder individual operated bootstrapped and is currently operating.
When was INCOG BioPharma founded?
INCOG BioPharma was founded in 2021. It employs 101 to 250 people.
Where is INCOG BioPharma based?
INCOG BioPharma is headquartered in Fishers, United States, in the North America region.
How does INCOG BioPharma make money?
One revenue line is on record: contract Manufacturing Services.
Does INCOG BioPharma have an API?
No public API is recorded for INCOG BioPharma.
What industry is INCOG BioPharma in?
INCOG BioPharma's product category is Contract Development and Manufacturing (CDMO) Services for Sterile Injectables. Its primary akta.pro industry code is HLAGABAH, Sterile Fill-Finish & Aseptic Manufacturing CDMO, with a secondary code of HLAGABAG, Drug Substance–Drug Product Integrated CDMO. Its NAICS code is 325412 and its SIC code is 8731.