What AGON Pharma does

AGON Pharma GmbH is a privately held German pharmaceutical services company founded in 1988 and headquartered in Wendlingen, Baden-Württemberg, with a secondary archive and climate testing facility in Leonberg. The company provides outsourced services to small and medium-sized pharmaceutical companies across three core areas: (1) Analytics — commissioned pharmaceutical analysis, method development and validation, stability testing across ICH climate zones, and batch release analytics performed in GMP-certified laboratories equipped with HPLC, U-HPLC, GC, and TLC systems from Shimadzu, Beckman Coulter, and other vendors; (2) Regulatory Affairs — conversion of dossiers to eCTD format, support during amendment proceedings, deficiency letter responses, and strategic consulting for marketing authorization acquisition; and (3) Development & Marketing Authorisation — medicinal product development and initiation of authorization procedures throughout Europe, leveraging a network of contract manufacturing and extract production partners. The company holds special expertise in herbal medicinal products (Phytopharmaka) and maintains ready-to-submit eCTD dossiers for peppermint oil, valerian, artichoke, ivy, and marshmallow-based products.

AGON operates as a B2B professional services firm with a sales-led go-to-motion, acquiring customers through direct consultation, professional networking, and industry events such as Vitafoods Europe. Pricing is project-based and quote-driven rather than publicly disclosed. The company is regulated under the oversight of Regierungspräsidium Tübingen, holding both a manufacturing authorization (DE_BW_01_MIA_2023_0052) and a GMP certificate for its pharmaceutical control laboratory, supplemented by DIN EN ISO 9001:2015 quality management certification. The company is a member of the Bundesverband der Arzneimittelhersteller (BAH) and Kooperation Phytopharmaka. AGON is led by managing directors Kerstin Stephan and Dr. Annette Wixforth, with Günter Stephan and Michael Schmidt heading development and authorization, and Dr. Michael Fischer leading regulatory affairs.

The business model is service-based, with revenue generated from commissioned analytical work under manufacturing authorization, regulatory affairs consulting engagements, and development partnerships. Geographic reach is primarily European (with Germany as the home market) and was extended in 2024 to include Saudi Arabia with the company's first Middle Eastern marketing authorization. The firm has accumulated more than 300 development, post-marketing, and marketing authorization procedures over its history and works with dozens of active substances.

Name

AGON Pharma

Legal name

AGON Pharma GmbH

Website

https://agon.de

Company type

Private

Founded year

1988

Operating status

Operating

Headcount range

11–50 employees

Short description

AGON Pharma GmbH is a German pharmaceutical services company founded in 1988 that provides GMP-certified analytical testing, regulatory affairs consulting, and marketing authorization services to small and medium-sized pharmaceutical companies, with particular expertise in herbal medicinal products across European and selected international markets.

Ownership category

akta.pro rank

Product category

Pharmaceutical Regulatory and Analytical Services

NAICS

Management Consulting Services (54161)

SIC

Services-Testing Laboratories (8734), Services-Health Services (8000)

akta.pro primary industry

Generic ANDA/Regulatory Affairs & Submissions (HLAIABAJ)

akta.pro secondary industry

Medication Inventory, Procurement & Supply Chain (Pharmacy) (HLACAKAI)

Keywords

• Pharmaceutical regulatory services
• Marketing authorization consulting
• Pharmaceutical analytics
• Herbal medicinal products
• Stability testing services

Headquarters

HQ city

Wendlingen

HQ country

Germany

HQ region

Europe

Offices2 records

Markets served

GTM type

B2B

Offering type

Services

Cost components

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

Revenue model

1. Contract Analytical Services: Commissioned analysis for pharmaceutical products including release testing, stability testing, method development and validation. Services performed under manufacturing authorization and GMP certificate.
2. Regulatory Affairs Services: Marketing authorization consulting, dossier preparation in eCTD format, amendment proceedings support, deficiency letter responses, and strategic advice for obtaining and maintaining marketing authorizations.
3. Product Development & Marketing Authorization: Development of medicinal products and initiation of marketing authorization procedures throughout Europe. Includes project proposals, dossier creation, and coordination of authorization procedures with partners.

Go-to-market motion1 record

Distribution channels2 records

Marketing channels3 records

Core offering

AGON Pharma is a pharmaceutical services company that provides contract analytical services (commissioned analysis, method development, stability testing, batch release analytics), regulatory affairs consulting (eCTD dossier preparation, marketing authorization support, amendment proceedings, deficiency letter responses), and medicinal product development services including initiation of marketing authorization procedures throughout Europe. The company operates a GMP-certified laboratory in Wendlingen, Germany, and leverages a partner network of contract manufacturers and extract producers to develop and obtain marketing authorizations for herbal medicinal products.

Product overview

AGON Pharma is a pharmaceutical services company founded in 1988, offering a portfolio of contract services including Analytics (commissioned analysis, stability testing, method development and validation), Regulatory Affairs (eCTD dossier conversion, amendment procedures, marketing authorisation consulting), and Development & Authorisation (medicinal product development and EU marketing authorisation procedures). The company has developed its own peppermint oil capsule product for irritable bowel syndrome and maintains ready-to-submit dossiers for valerian, artichoke, ivy, and marshmallow-based herbal medicinal products. Core services are delivered through in-house GMP-certified laboratories equipped with HPLC, GC, and TLC systems, and a partner network of pharmaceutical manufacturers and extract producers including Ayanda, Finzelberg, Wiewelhove, and Anklam Extrakt.

Differentiator

Problem solved

Functional benefit

Products and services

• Analytics Services Commissioned pharmaceutical analysis including routine analytics, method development, stability testing, and batch release analytics performed in a GMP-certified laboratory, for pharmaceutical companies requiring outsourced analytical capacity.
• Regulatory Affairs Services Pharmaceutical regulatory consulting including conversion of dossiers to eCTD format, support during amendment proceedings, deficiency letter responses, and strategic consulting for the acquisition and maintenance of national and international marketing authorisations.
• Development & Marketing Authorisation Services Medicinal product development and initiation of marketing authorisation procedures throughout Europe, leveraging AGON's network of contract manufacturing and extract production partners. Includes project proposals, dossier creation, and coordination of authorisation procedures.
• Active Substance Expertise Services Marketing authorisation and post-marketing procedures for dozens of active substances, providing clients access to established analytical methods, core documentation packages, and literature reviews built through prior authorisations.
• Peppermint Oil Capsules (Pfefferminzöl Kapseln) Gastroresistant softgel capsules with 182 mg peppermint oil for symptomatic relief of minor spasms of the gastrointestinal tract, flatulence and abdominal pain, particularly in patients with irritable bowel syndrome. Marketing authorizations have been obtained in multiple European countries.
• Valerian Dragee (Baldrian Dragee) Dragee with 445 mg valerian root dry extract for relief of mild nervous tension and sleep disorders, based on HMPC Monograph Valeriana officinalis L., radix. Dossier in eCTD format ready for submission.
• Artichoke Film Tablets (Artischocken Filmtabletten) Film-coated tablet with 600 mg artichoke leaf dry extract for symptomatic relief of digestive disorders such as dyspepsia with sensation of fullness, bloating and flatulence, based on HMPC monograph. Dossier in eCTD format ready for submission.
• Ivy Lozenges (Efeu Pastille) Lozenge with 26 mg ivy leaf dry extract used as expectorant for productive cough, based on HMPC monograph. Dossier in eCTD format ready for submission within 3 months.
• Ivy Solution (Efeu Lösung) Oral solution with 0.6 g/100 ml ivy leaf dry extract used as expectorant, based on HMPC monograph. Dossier in eCTD format ready for submission within 6 months.
• Marshmallow Lozenges (Eibisch Pastillen) Lozenge with 125 mg marshmallow root dry extract for symptomatic treatment of oral or pharyngeal irritation and associated dry cough, based on HMPC monograph. Dossier in eCTD format ready for submission.
• Marshmallow Solution (Eibisch Lösung) Oral solution with 3.375 g/100 g marshmallow root dry extract for symptomatic treatment of oral/pharyngeal irritation and dry cough, based on HMPC monograph. Dossier in eCTD format ready for submission within 9 months.

Quantifiable outcome

• Successfully obtained marketing authorization in Saudi Arabia for a Saccharomyces cerevisiae capsule product
• +1 more outcomes

Named customers2 records

Segments2 records

Ideal customer profiles2 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature4 records

Partnerships

Five partnerships are on record, tiered core.

• Ayanda GmbHcoreStrategic or Co-development PartnerAyanda GmbH, Falkenhagen is a partner in AGON's network of strong partners for contract pharmaceutical manufacturing and extract production. The partnership enables AGON to offer a comprehensive package from product idea through active substance procurement, manufacturing, and preparation and submission of marketing authorization documentation.
• BOLDER Arzneimittel GmbH & Co. KGcoreStrategic or Co-development PartnerBOLDER Arzneimittel GmbH & Co. KG, Köln is part of AGON's established network of manufacturing partners. The partnership contributes to AGON's ability to provide a complete service offering for pharmaceutical product development.
• Finzelberg GmbH & Co KG (Martin Bauer Group)coreStrategic or Co-development PartnerFinzelberg GmbH & Co KG - Martin Bauer Group, Andernach is a key partner in AGON's network, specializing in extract production for pharmaceutical applications. The partnership supports AGON's herbal medicinal product development capabilities.
• Wiewelhove GmbHcoreStrategic or Co-development PartnerWiewelhove GmbH, Ibbenbüren is a trusted partner in AGON's network of pharmaceutical contract manufacturers. The partnership enables AGON to offer a broad range of dosage forms and innovations to clients.
• Anklam Extrakt GmbHcoreStrategic or Co-development PartnerAnklam Extrakt GmbH, Anklam is a partner in AGON's network specializing in extract production. The partnership contributes to AGON's comprehensive service offering for herbal medicinal product development and manufacturing.

Scale indicators4 records

Recent moves10 records

Expansion highlights6 records

Direct peers

• Eurofins Scientific: Eurofins is the largest global contract testing provider for pharmaceutical products, running HPLC/GC stability, release, and method validation services. Like AGON, it serves pharma companies needing GMP-compliant analytical work, but at a vastly larger scale across many geographies.
• Intertek: Intertek offers pharmaceutical analytical services, including stability testing, method development, and batch release testing, mirroring the contract analytical proposition AGON delivers to its SME pharma clients.
• Hermes Arzneimittel: Hermes Arzneimittel is a German mid-sized pharmaceutical company with its own regulatory and product development capabilities, often partnering with smaller sponsors on marketing-authorization projects in herbal and OTC categories — directly comparable in scope to AGON's SME-pharma focus.
• Charles River Laboratories: Charles River's Manufacturing Solutions segment includes pharmaceutical testing, stability, and regulatory support, competing for the same outsourcer wallet as AGON across both small and larger pharma sponsors.
• PharmaLex (Cencora): PharmaLex (now part of Cencora) provides regulatory affairs consulting, dossier preparation, and product development strategy for pharma companies. It competes for marketing-authorization mandates and eCTD conversion work that AGON performs.
• Diapharm: Diapharm is a German-based pharmaceutical regulatory affairs and quality consulting firm specifically supporting SMEs with marketing authorization, eCTD preparation, and lifecycle maintenance — a near-direct SME-focused competitor to AGON's regulatory offering.
• SGS (Life Sciences): SGS provides pharmaceutical laboratory testing, stability storage, and quality/release analytics under GMP conditions, directly overlapping AGON's analytics service line for both human and herbal medicinal products.

Broad incumbents

• Vetter Pharma: Vetter is a leading CDMO specializing in aseptic fill/finish for injectables, with regulatory and analytical support services. It is comparable only loosely; Vetter operates at a far larger scale and different dosage-form focus than AGON's herbal/solid-oral specialization.
• Recipharm: Recipharm is a large European CDMO offering contract manufacturing plus integrated regulatory and development services. It operates broader in drug substance and finished product manufacturing rather than specializing as AGON does in herbal dossiers and analytical testing.
• Aenova Holding: Aenova is a major European CDMO offering solid, semi-solid, and liquid dosage forms with regulatory services, comparable only in the regulatory/development slice but much larger in manufacturing scale than AGON.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat5 records

Key risks5 records

Key highlights7 records

Customer concentration

Compliance3 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles4 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 AGON Pharma