American Injectables

What American Injectables does

American Injectables is a privately held, FDA-approved U.S. contract development and manufacturing organization (CDMO) specializing in sterile injectable drug products. Founded in 2020 and headquartered in Brooksville, Florida, the company operates a purpose-built fill-finish facility comprising approximately 20,000 sq ft of fill-finish space, a 2,500 sq ft laboratory, 10,800 sq ft of packaging and warehouse capacity, and 10,000 sq ft of ISO 5/7 cleanrooms. It serves pharmaceutical companies, biotech firms, and drug sponsors from early development through commercial supply, with a stated focus on orphan drugs, branded injectables, generic injectables (505b2 and 505j ANDA pathways), and products on the FDA Essential Medicines list.

The company's technical core is a sterile injectable platform anchored on an Optima syringe filling line, a Bosch vial filling line (2R to 50R formats), Fedegari autoclave and dry heat sterilization, and Girton CIP/SIP systems. Operations are managed through a custom electronic plant management system providing real-time equipment monitoring, database analytics, electronic maintenance, and asset tracking, with triple-backed data systems for integrity. Service offerings span formulation development, analytical and stability testing, process engineering, cGMP manufacturing with batch sizes from under 1,000 to 150,000 units, quality assurance, packaging, and CMC/regulatory planning. Currently installed capacity is 16 million units annually, expandable to 50 million, and a multi-line facility expansion is underway with GMP readiness targeted for Q1 2026.

American Injectables generates revenue through project-based CDMO contracts covering formulation, analytical, manufacturing, and regulatory services, with flexible terms including multi-product development and profit/risk-sharing arrangements. The company goes to market via enterprise field sales led by SVP of Business Development Brittany Siqueiros, supported by LinkedIn, content marketing, and a quote-request workflow on its website. The company has raised a cumulative $29 million in Series A funding from New Rhein Healthcare Investors across 2020 and 2022, received FDA approval in January 2025, and completed its first commercial batch for a rare metabolic disorder therapy in December 2025.

Name

American Injectables

Legal name

American Injectables

Website

https://americaninj.com

Company type

Private

Founded year

2020

Operating status

Operating

Headcount range

11–50 employees

Short description

American Injectables is a privately held, FDA-approved U.S. CDMO headquartered in Brooksville, Florida that provides sterile injectable fill-finish and development services to pharmaceutical, biotech, and drug-sponsor clients from clinical through commercial supply.

Ownership category

akta.pro rank

Product category

Sterile Injectable CDMO Services

NAICS

Pharmaceutical Preparation Manufacturing (325412)

SIC

Pharmaceutical Preparations (2834)

akta.pro primary industry

Sterile Fill-Finish & Aseptic Manufacturing CDMO (HLAGABAH)

akta.pro secondary industries

Clinical Trial Material (CTM) Manufacturing & Supply CDMO (HLAGABAK), Contract Development & Manufacturing for Generics (CDMO/CMO) (HLAIABAI)

Keywords

• Sterile injectable manufacturing
• Contract development manufacturing
• Parenteral drug manufacturing
• Vial syringe filling
• Aseptic fill-finish

Headquarters

HQ city

Tampa

HQ country

United States

HQ region

North America

Offices1 record

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

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

Revenue model

1. Contract Development and Manufacturing Services: Full-service CDMO providing sterile injectable manufacturing from development through commercial supply. Revenue generated through project-based contracts for formulation, analytical services, manufacturing, and regulatory support. Flexible partnership models including profit/risk-sharing arrangements.
2. Manufacturing Services: cGMP manufacturing of sterile injectables including vial and syringe filling. Revenue from batch production fees based on flexible batch sizes from clinical to commercial scale.

Pricing tiers

Go-to-market motion2 records

Distribution channels1 record

Marketing channels4 records

Core offering

American Injectables is a U.S.-based FDA-approved Contract Development and Manufacturing Organization (CDMO) that manufactures sterile injectable drug products through cGMP vial filling and syringe filling operations. The company offers an integrated end-to-end platform spanning formulation development, analytical and stability testing, process engineering, manufacturing, quality assurance, packaging, and launch/regulatory planning for pharmaceutical and biotech clients from clinical development through commercial supply.

Product overview

American Injectables is a U.S.-based FDA-approved Contract Development and Manufacturing Organization (CDMO) specializing in sterile injectables. The company operates as a unified platform combining vial filling and syringe filling as its two core manufacturing products, supported by a comprehensive suite of service modules including formulation services, analytical and stability services, process engineering, manufacturing, quality assurance, packaging, and launch/regulatory planning. This end-to-end integrated approach enables seamless progression from early development through commercial supply, with all services designed to work cohesively within their FDA-approved facilities.

Differentiator

Problem solved

Functional benefit

Products and services

• Vial Filling Ready-to-use glass or plastic vial filling services supporting 2R to 50R vial sizes with 100% In-Process-Control, nitrogen flushing, and peristaltic filling, designed for pharmaceutical and biotech clients needing cGMP sterile injectable vial manufacturing.
• Syringe Filling Ready-to-use nested syringe filling services for 1 mL long and 1 to 50 mL syringes with statistical In-Process-Control, vent and vacuum stoppering, and rotary piston for viscous filling, intended for pharmaceutical clients requiring cGMP sterile syringe fill-finish.
• Formulation Services Formulation development services including optimization, proof-of-concept studies, API evaluation with various excipients, and clinical trial material manufacturing for pharmaceutical and biotech sponsors developing sterile injectable drug products.
• Analytical and Stability Services Raw material, in-process, and finished product testing to verify drug purity, potency, and regulatory compliance, plus ICH stability studies for shelf life determination, supporting pharmaceutical client regulatory submissions.
• Process Engineering Engineering batches, validation batches, and registration batches with integrated electronic management system providing critical data and documentation for FDA filings.
• Manufacturing Services Sterile injectable cGMP manufacturing with flexible batch sizes from less than 1,000 to 150,000 units, supporting orphan and branded drugs with strict cGMP adherence and FDA-approved quality systems.
• Packaging Services Small-scale packaging currently available with automated cartoning of syringes and vials, with automated syringe assembly coming in 2026.
• Launch and Regulatory Planning CMC (Chemistry, Manufacturing, and Controls) documentation support, material and finished goods management, and GMP warehousing services for pharmaceutical clients preparing commercial launch.

Quantifiable outcome

• First commercial batch delivered to patients nationwide for rare metabolic disorder therapy
• +2 more outcomes

Named customers2 records

Segments3 records

Ideal customer profiles3 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature7 records

Partnerships

Seven partnerships are on record, tiered core and minor.

• Kimberlee SteelecoreOthers · 1 January 2025Managing Director, North America at SHL Medical (autoinjector drug delivery devices). Former Vice President, Strategic Partners at Catalent with 25+ years in pharmaceutical, medical device, consulting and technology. Appointed to Board January 2025.
• Paul CampanellicoreOthers · 1 March 2024Former CEO of Endo International and Par Pharmaceutical. Joined Board in March 2024 and transitioned to Executive Chairman. Brings tenured sterile products expertise from leadership at Par Pharmaceutical and Endo International.
• Subhanu SaxenacoreOthers · 1 March 2024Former Managing Director & Global CEO of Cipla (global pharma company with presence in 170+ countries). Managing Partner at New Rhein Healthcare Investors since 2017. Brings extensive pharmaceutical operations experience.
• Greg ParekhcoreOthers · 1 March 2024Founded New Rhein Healthcare Investors in 2010. Previously led M&A at Novartis AG (2004-2009), executing over 20 transactions with $70+ billion total deal value. Led integration planning for Alcon on behalf of Novartis.
• Carlo De NotaristefanicoreOthers · 1 March 2024International operations senior executive with global technical, operational, and P&L experience. Former Executive VP of Operations at Teva Pharmaceuticals. Lead advisor for Manufacturing and Supply Chain to Operation Warp Speed/Federal Covid Response since May 2020.
• Akhil AkulaminorOthers · 1 March 2024Vice President at New Rhein Healthcare Investors. Previously worked at Pfizer on corporate development team and was a founding member of Pfizer Breakthrough Growth Initiatives ($500 million investment vehicle).
• Namigen LLCcoreStrategic or Co-development Partner · 1 August 2021Partnership to manufacture and commercialize an injectable drug listed on FDA's Essential Medicines list for hospital use. Namigen LLC is a virtual pharmaceutical company led by Nathan Barishansky and Michael Major.

Scale indicators6 records

Recent moves8 records

Expansion highlights5 records

Broad incumbents

• Lonza: Global CDMO leader with significant sterile injectable fill-finish capacity across multiple sites. Larger and more diversified but competes directly for sterile injectable outsourcing programs from pharma sponsors.
• Fresenius Kabi: Major sterile injectable manufacturer with substantial U.S. operations producing generic injectable pharmaceuticals and offering contract manufacturing. Overlaps with American Injectables in the U.S. generic and branded injectable CDMO space.
• Patheon (Thermo Fisher Scientific): Operates one of the largest global CDMO networks including sterile injectable manufacturing. Competes with American Injectables for outsourced sterile fill-finish work as part of a much broader pharma services portfolio.
• Hikma Pharmaceuticals: Global generic injectable manufacturer with U.S. manufacturing and a pipeline of sterile injectable products. Comparable to American Injectables' generic and 505j ANDA pathway orientation within a much larger commercial footprint.

Direct peers

• Grand River Aseptic Manufacturing (GRAM): U.S.-based FDA-inspected sterile injectable CDMO specializing in aseptic fill-finish of vials, syringes, and cartridges. Closely comparable to American Injectables in focus, regulatory positioning, and domestic U.S. value proposition.
• Catalent: Major global sterile injectable fill-finish CDMO with extensive vial and syringe capabilities across multiple U.S. and European sites. Direct competitor for pharmaceutical sponsors seeking outsourced sterile injectable manufacturing, including commercial and clinical supply.
• Baxter BioPharma Solutions: Operates a sterile contract manufacturing business for injectables and other dosage forms, serving pharma and biotech customers. Comparable as a U.S.-based sterile injectable CDMO with parenteral fill-finish expertise.
• Recipharm: Global CDMO with sterile injectable manufacturing services including aseptic fill-finish. Direct competitor for outsourced sterile injectable development and commercial manufacturing contracts.
• Aenova: European-headquartered CDMO with sterile injectable fill-finish capabilities serving pharmaceutical companies. Comparable as a contract manufacturer competing for similar vial and syringe outsourcing programs.
• Curia: Global CDMO offering sterile injectable development and manufacturing services. Direct competitor for CDMO contracts and notably the prior employer of American Injectables' SVP of Business Development, Brittany Siqueiros.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat4 records

Key risks6 records

Key highlights7 records

Customer concentration

• LinkedInlinkedin.com/company/american-injectables

Compliance2 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles10 records

Funding overview

Funding rounds1 record

Investors1 record

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 American Injectables