Pilot Ossa Logo

We Connect Leading Brands with Global Markets.

One partner. Three core capabilities.

With over 60 years of experience, we integrate CGMP/USP standards, industrial production, and a Full Cycle Partners model to take your project from concept to market.

We are your strategic partner in Mexico and Latin America, with the capability to execute and scale in regulated environments.

Who We Are

Your bridge between innovation and the global marketplace

We are specialized manufacturers connecting innovation in active ingredients and specialty chemicals with the pharmaceutical, personal care, and industrial industries.

Based in Mexico, with coverage across Latin America and international markets, we integrate manufacturing, specialized distribution, and custom development to take your project from concept to market.

We hold a license in Mexico for the production of regulated chemicals and operate in alignment with FDA (U.S.) and PMDA (Japan) standards for API manufacturing.

Our Track Record in Numbers

+0K

tons produced

+0

products in our portfolio for domestic and export markets

+0

years of experience in regulated industries

+0

active customers

0%

-time delivery performance

Installed Capacity

+0

tons/year at our CGMP facility

+0K

tons/year at our industrial plant

Our Purpose

Innovating to Create Real Impact

We drive the development of products in Personal Care, HI&I, and specialized industries, enabling their transition from concept to commercial production.

More than a distributor, we are a trusted CRDMO partner, integrating development, manufacturing, and scale-up.

Our promise

To be the partner that turns technical complexity into reliable execution from formulation to commercial production.

Value Proposition Hero
Value Proposition Hero
Pilot ossa

Our

history

Over 60 years of evolution
A global scale platform

1966

Foundation

Organo sintesis is founded in Mexico City, driven by the vision of developing speciality chemicals for highly demanding industries.

1979

Relocation

Organo Sintesis moves its operations to the State of Mexico, strengthening its operational capabilities and aligning with the demands of the industrial sector.

2019

Global Integration

We join Pilot chemical, combining local expertise with international capabilities and reach.

2025

Consolidation

Pilot Ossa is established as a robust platform, with a portfolio of over 100 products, presence in more than 10 countries, and a specialized technical team.

Now

Strategic Partner.

A platform designed to understand global markets from Mexico, with in-house infrastructure, controlled logistics, and compliance with CGMP standards.

Technical Capability

Three capabilities a
single partner.

01CGMP / USP

1

CGMP / USP Capability

We manufacture under CGMP and USP standards, ensuring quality, traceability, and regulatory compliance for applications in demanding markets.

Infrastructure & Compliance

  • Successful FDA audit (2023).
  • PMDA accreditation valid through 2026.
  • Full traceability from raw materials to finished product.

Key use applications.

Pharmaceutical
  • Parenterals, ophthalmic products, lyophilized products, vaccines and injectables
Healthcare
  • Mouthwashes, toothpastes and sanitizing solutions.
Animal health
  • Creams, ear drops and veterinary sanitation solutions.

02Industrial grade

2

Industrial grade capability. 

We develop and manufacture robust chemical specialties for industrial applications that demand reliability, stability and consistent performance.

Our infrastructure includes: 

  • Glass lined and stainless steel reactors.
  • Pilot plant for process development and scale up.

Industries we serve:

Oil & gas
Lubricants and metalworking
Polymerization and Coatings
Water treatment

Functional Chemistry Expertise

  • Cetylpyridinium Chloride
  • Biocides
  • Chlorphenesin
  • Preservatives
  • Benzalkonium Chloride
  • CDMO / CRO solutions
  • Myristyl Ammonium Chloride

03Full Cycle Partners

3

Full Cycle Partners

Your partner from idea to market. We integrate flexibly at any stage of your project.

Beyond manufacturing, we offer a complete ecosystem for development, scale-up, and technical support to accelerate your time to market.

Our Comprehensive Services:

Analytical Methods

  • Development, validation/verification, optimization, transfer, performance evaluation (maintenance of validated status), and method comparability.

Stability

  • Study design, full project management, rental of climatic chambers, development of stability-indicating methods, IE method validation, and case examples.

Microbiology

  • Selection and evaluation of disinfectants and sanitizers, formulation, staff training, disinfectant/sanitizer rotation programs, safety and control.
  • Minimum Inhibitory Concentration (MIC).
  • Microbial limits – MGA 0571.

Physicochemical Testing

  • Karl Fischer water determination, volumetry, chromatography, volatile organic impurities, COD, color, alcoholic beverage–specific analyses, boiler water analysis, loss on drying, pH, residue on ignition, and infrared spectrophotometry.

Research & Development

  • Complete impurity profiles, related substances, and finished products.
  • Custom synthesis and manufacturing of compounds, impurity synthesis, and tailor-made liquid formulations.
  • Technology transfer from laboratory to pilot plant.
  • Scale-up to commercial production.

Efficiency at every stage, from laboratory → pilot plant → commercial production, without compromising quality or traceability.

International Reach

A platform with global presence

Headquarters & Plants

Toluca, México.

Pilot Chemical Corporate Headquarters

West Chester, Ohio (U.S.A)

Distribution

Japan, South Korea, United States, Caribbean, Central America, Andean Region, South America, Mexico.

Commercial Partnerships

Colombia, Central America, Mexico, Argentina, Dominican Republic.

Production & Technology Centers

Cincinnati, Middletown, Avenel, Lockland, Houston (U.S.A).

Infrastructure

CGMP-compliant facilities, warehouses, and services.

Our operations integrate a CGMP facility, industrial production, and a pilot plant within a single complex, supported by validated processes, full traceability, and international quality standards.

030201
01

CGMP Facility

A certified facility for the manufacturing of APIs and regulated products, featuring three cleanrooms and a Quality Management System based on ICH Q7 and FDA guidelines.

02

Industrial Production

Robust infrastructure for high-performance chemical specialties.

Plant 1:

3 glass-lined reactors

Plant 2:
  • 3 glass-lined reactors
  • 2 stainless steel reactors
  • 1 distillation unit
Production:

Quaternary ammonium compounds, amine oxides, and intermediates.

03

Pilot Plant

A dedicated space for the development and scale-up of new products, enabling an efficient transition from laboratory to commercial production.

Strategic Location

Km. 10.8 Amomolulco Highway, Capulhuac Municipality 52700, State of Mexico, Mexico.

View on Google MapsView on Google Maps

Ready to work with a strategic partner?

We bring the technical capabilities, regulatory expertise, and operational flexibility your project needs. From portfolio products to custom molecule development, we are ready to turn your vision into successful execution.