What Agno Pharma does

Agno Pharma is a US-headquartered, privately held global Contract Development and Manufacturing Organization (CDMO) serving pharmaceutical, biotechnology, and generic drug companies across the small-molecule drug lifecycle. Founded in 2004 and led by founder-CEO James J. Chen, Ph.D., the company operates approximately 500 employees across 700,000+ sq ft of manufacturing space, with facilities in Bethlehem, Pennsylvania (US headquarters), Suzhou and Lianyungang, China, and Eugene, Oregon (added via the January 2026 Actylis acquisition). Its service portfolio is organized into four integrated lines: API and Intermediates (R&D, cGMP manufacturing from preclinical through commercial, HPAPI up to OEB 5, sterile API and powder fill), Drug Product (complex formulation, nanomilling, and cGMP injectables, ophthalmics, orals, and topical manufacturing), Long-Acting Implants and LAIs (hot melt extrusion, injection molding, cryomilling, and solvent impregnation), and Analytical Services (method development, validation, and ICH stability programs).

The technology platform is anchored by proprietary SteriMill aseptic nanomilling, which the company reports has contributed to FDA approval of over 18 nanomilled drug products since 2000, alongside flow hydrogenation, enzymatic chemistry (with 20+ enzyme-related patents), OEB 5 HPAPI containment to 0.1 ug/m³, and hot melt extrusion using PLGA, PCL, TPU, EVA, and silicone polymers. Agno owns 60+ patents and has filed extensively across process chemistry and formulation methods, supporting a regulated manufacturing track record that includes five successful FDA inspections (2014, 2018, 2020, 2021, 2024) and ISO 13485:2016 certification for its Particle Sciences division. December 2023's acquisition of Particle Sciences Inc. from Lubrizol added advanced formulation and drug-device combination product capability, and the January 2026 acquisition of Actylis's Eugene site added over two decades of small-molecule API expertise plus a 30,000 sq ft GMP manufacturing plant.

Revenue is generated through project-based CDMO contracts with pharmaceutical, biotech, and generic sponsors, covering everything from preclinical GLP batches and Phase 1 through commercial manufacturing with quote-based, multi-year pricing tied to scope, batch size, and complexity. The go-to-market is direct enterprise sales supported by a senior scientist-led business development team, supplemented by participation in major industry conferences (CPhI, Bio International, AAPS, PODD) and technical thought leadership content. The company is venture- and private-equity-backed (Vivo Capital historically; Bain Capital referenced in marketing materials) and pursues inorganic growth alongside organic capacity expansion, as evidenced by the 2024 build-out of new isolator-based cleanrooms and a dedicated commercial intravaginal ring and filling-line facility.

Name

Agno Pharma

Legal name

Agno Pharma LLC

Website

https://agnopharma.com

Company type

Private

Founded year

2004

Operating status

Operating

Headcount range

251–500 employees

Short description

Agno Pharma is a US-headquartered global pharmaceutical CDMO providing end-to-end small-molecule development, API manufacturing, sterile injectables, HPAPI, and long-acting implant services to pharmaceutical, biotech, and generic drug sponsors from facilities in the US and China.

Ownership category

akta.pro rank

Product category

Pharmaceutical CDMO Services

NAICS

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

SIC

Pharmaceutical Preparations (2834), Medicinal Chemicals & Botanical Products (2833)

akta.pro primary industry

Drug Substance–Drug Product Integrated CDMO (HLAGABAG)

akta.pro secondary industries

Small-Molecule API & Intermediates CDMO (HLAGABAA), Small-Molecule Drug Product (Solid/Oral/Parenteral) CDMO (HLAGABAB), Clinical Trial Material (CTM) Manufacturing & Supply CDMO (HLAGABAK)

Keywords

• Pharmaceutical CDMO services
• API manufacturing
• Drug product formulation
• Sterile injectable manufacturing
• High-potency API

Headquarters

HQ city

Piscataway

HQ country

United States

HQ region

North America

Offices4 records

Markets served

GTM type

B2B

Offering type

Services

Cost components

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

Revenue model

1. CDMO Contract Manufacturing Services: Contract development and manufacturing organization providing end-to-end pharmaceutical services including API manufacturing, drug product formulation, and sterile manufacturing. Revenue is generated through project-based contracts with pharmaceutical, biotech, and generic companies. Services span from preclinical through commercial manufacturing with pricing based on project scope, batch sizes, and development phase.
2. API and Intermediate Manufacturing: Manufacturing of active pharmaceutical ingredients, regulatory starting materials (RSMs), and chemical intermediates under cGMP and non-GMP conditions. Revenue derived from production contracts for clinical and commercial supply.
3. Generic API Supply: Supply of generic APIs to Market Authorization Holders, including both common and challenging APIs with some available through exclusive US marketing partnerships.

Pricing tiers

Go-to-market motion1 record

Distribution channels1 record

Marketing channels4 records

Core offering

Agno Pharma is a global end-to-end pharmaceutical Contract Development and Manufacturing Organization (CDMO) that develops and manufactures active pharmaceutical ingredients (APIs), drug products, sterile injectables, long-acting implants, and provides analytical services. The company serves pharmaceutical, biotechnology, and generic drug companies across the full drug development lifecycle from preclinical through commercial manufacturing, with specialized expertise in complex formulations, nanomilling, hot melt extrusion, and high-potency API handling.

Product overview

Agno Pharma is a US-headquartered, global end-to-end pharmaceutical CDMO (Contract Development and Manufacturing Organization) established in 2004. The company operates as a unified platform offering comprehensive services spanning from API development and manufacturing (including Intermediates, API, HPAPI, and Sterile API) through drug product formulation, manufacturing, and analytical services. The portfolio is organized into integrated service lines: (1) API & Intermediates covering R&D expertise and cGMP manufacturing capabilities from preclinical through commercial scale; (2) Drug Product covering complex formulation development, milling/nanomilling services, and cGMP clinical/commercial manufacturing for injectables, ophthalmics, orals, and topicals; (3) Long-Acting Implants & LAIs covering hot melt extrusion, injection molding, cryomilling, and solvent casting for drug implant development; and (4) Analytical Services covering method development, validation, and ICH-compliant stability programs. In December 2023, Agno Pharma acquired Particle Sciences Inc. (PSI), adding specialized formulation development capabilities for pre-clinical and clinical stage drug products including nanoformulation and implantable devices. The company operates manufacturing facilities in Bethlehem, PA (USA), Suzhou (China), and Lianyungang (China), with approximately 500 employees including 90+ scientists, 15+ PhDs, and 60+ quality professionals.

Differentiator

Problem solved

Functional benefit

Products and services

• API & Intermediates Development and Manufacturing Comprehensive API development and manufacturing services including New Chemical Entities, generics, Regulatory Starting Materials (RSMs), chemical intermediates, and High-Potency APIs (HPAPI) up to OEB 5 with sterile API capabilities. Services span synthetic route scouting, process development, Quality-by-Design approaches, GLP batches, cGMP clinical manufacturing, and commercial-scale production. Targeted at pharmaceutical and biotech companies developing small-molecule drugs.
• Drug Product Formulation Development Advanced formulation services addressing solubility and bioavailability enhancement, long-acting dosage forms, micro/nanotechnology, biopharmaceuticals, microspheres, suspensions, emulsions, lyophilization, and liquid fill. Designed for pharmaceutical and biotech clients requiring complex formulation solutions for challenging molecules.
• Milling, Micronizing and Nanomilling Services Particle size engineering using wet milling (nanomilling with proprietary SteriMill), dry milling (micronization via jet milling), and high-energy media milling for BCS Class II/IV APIs from concept through commercial manufacturing. Targeted at companies developing poorly water-soluble drug products.
• Sterile Powder Fill and Injectable Manufacturing Aseptic powder filling services for cytotoxins using dual dosing head system, with batch capabilities of 25,000 vials at 500 mg, 10,000 vials at 1 g, or 5,000 vials at 2 g. Includes cGMP injectable finished dose manufacturing with aseptic liquid fill, proprietary aseptic nanomilling, nano/coarse suspensions, terminal sterilization, and lyophilized products. For pharmaceutical clients requiring sterile injectable manufacturing.
• High-Potency API (HPAPI) Manufacturing OEB 5 high-potency API production in contained workshops with cGMP-compliant isolators, reactors up to 500 L, and batch production capacity of 1-10 kg. Includes sterile HPAPI production up to 25 kg batches. Designed for pharmaceutical companies developing cytotoxic oncology and other potent therapeutics requiring containment down to 0.1 ug/m3.
• Long-Acting Implants and Drug Delivery Systems Long-acting drug delivery systems including ophthalmic implants, subcutaneous implants, vaginal rings, pessaries, films, and tubing using hot melt extrusion, injection molding, polymeric cryomilling, and solvent impregnation/casting/coating with PLGA, PCL, TPU, EVA, and silicone polymers. Supports HPAPI and controlled substance handling. For pharmaceutical clients developing long-acting injectables and implantable therapeutics.
• cGMP Clinical Drug Product Manufacturing Clinical trial material manufacturing with full in-house analytical capabilities, stage-appropriate method validation, ISO 5 suites for aseptic processing, and lyophilization for biologics. Serves biotech and pharmaceutical clients requiring clinical-stage drug product supply.
• cGMP Commercial Drug Product Manufacturing Flexible commercial manufacturing with 3,000 sq ft cleanroom space, ISO 5 suites, 120 sq ft commercial lyophilizer with CIP/SIP, and particle size reduction including aseptic nanomilling at commercial scale. Targeted at pharmaceutical companies with approved products requiring commercial supply.
• Analytical Methods Development and Validation Comprehensive method development and validation services for small molecules through biologics (peptides, proteins, oligonucleotides) with advanced analytical instrumentation. Supports pharmaceutical and biotech clients across drug development stages.
• ICH-Compliant Stability Programs ICH stability testing with walk-in chambers (5°C, 25°C/60%RH, 30°C/65%RH, 40°C/75%RH), photostability testing per ICH Q1B, and semi-permeable packaging programs supporting global development. Designed for pharmaceutical clients requiring regulatory-compliant stability data.

Quantifiable outcome

• FDA approval of over 18 nanomilled drug products since 2000
• +1 more outcomes

Named customers3 records

Segments4 records

Ideal customer profiles3 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature6 records

Partnerships

Three partnerships are on record, tiered core.

• DelAQUA PharmaceuticalscoreStrategic or Co-development Partner · 29 January 2026Strategic collaboration to integrate DelAQUA's polymeric micelle drug delivery platform with PSI's formulation development capabilities. Combines PSI's expertise in implantable and sustained-release formulations with DelAQUA's solubility-enhancing technology to deliver next-generation drug delivery solutions. Enables accelerated development timelines and formulations aligned with customer target product profiles.
• SiCare BiocoreStrategic or Co-development Partner · 1 August 2025Strategic partnership to scale advanced drug delivery platform. Combines SiCare Bio's drug delivery expertise with Agno Pharma's manufacturing capabilities to offer enhanced solutions to pharmaceutical clients.
• Particle Sciences Inc.coreOthers · 1 December 2023Acquired by Agno Pharma in December 2023, Particle Sciences (PSI) operates as a division of Agno Pharma. PSI specializes in pre-clinical and clinical stage drug product formulation, including nanoformulation, hot melt extrusion, implantable devices, and sustained-release formulations. Founded in 1991 and based in Bethlehem, Pennsylvania.

Scale indicators8 records

Recent moves8 records

Expansion highlights6 records

Direct peers

• Catalent: Global CDMO with deep capabilities in sterile injectables, softgel/orals, and biologics fill-finish. Direct competitor for Agno's injectable, oral, and complex formulation services, particularly with biotech and innovator pharma clients.
• Hovione: Specialty CDMO focused on complex small-molecule API, particle engineering, and inhalation/sterile dosage forms. Highly comparable to Agno's API plus nanomilling plus sterile injectable positioning, with similar HPAPI capability.
• Piramal Pharma Solutions: Integrated CDMO offering API, HPAPI, sterile injectables, and drug product development. Directly comparable to Agno's end-to-end API-to-drug-product model, with strong overlap in HPAPI and complex formulation services.
• Siegfried Holding: Swiss CDMO with strong small-molecule API and finished dose capabilities. Competes with Agno for small-molecule API and drug product contracts, particularly from European innovator pharma clients.
• Cambrex (Eurofins Discovery/Cambrex): Small-molecule API and finished dosage CDMO with deep expertise in controlled substances, HPAPI, and complex chemistries. Highly comparable to Agno's API, intermediates, and HPAPI service lines.
• Aenova Group: European CDMO with solid dose, semi-solid, and sterile manufacturing capabilities. Comparable to Agno in oral solid dose, sterile injectables, and formulation development, particularly for mid-sized pharma clients.
• PCI Pharma Services: CDMO with strong capabilities in sterile injectables, clinical trial supply, and commercial packaging. Comparable to Agno in injectable fill-finish, clinical manufacturing, and biotech-focused service offerings.
• Alcami Corporation: US-headquartered CDMO offering API development, sterile and oral solid dose manufacturing, and analytical services. Comparable mid-sized US-based CDMO competing with Agno for analytical, API, and drug product contracts.
• Curia (formerly AMRI): Contract development and manufacturing organization with API, drug product, and analytical services. Directly comparable to Agno's integrated CDMO model, with overlap in small-molecule API, sterile injectables, and analytical offerings.

Broad incumbents

• Lonza: World's largest CDMO with broad small-molecule API, biologics, and cell-and-gene therapy services. Overlaps with Agno in HPAPI, API, and sterile fill-finish, but operates at materially larger scale and global reach.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat6 records

Key risks6 records

Key highlights7 records

Customer concentration

Compliance2 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles8 records

Subsidiaries4 records

Funding overview

Funding rounds1 record

Investors1 record

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

M&A1 record

Investments

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

Frequently asked questions about Agno Pharma