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INDUSTRY

Pharmaceutical/ Veterinary

APIs and regulated products under CGMP standards. Technical solutions and specialized materials for pharmaceutical applications that require quality, traceability and regulatory compliance. With FDA and PMDA registration for API manufacturing.

Key Aspects

We deliver solutions that help improve quality of life, backed by science, safety and efficiency, in line with international best practices.

Our capabilities:

Manufacturing under CGMP standards

Production aaligned with global requirements, with a successful FDA audit (2023) and PMDA accreditation valid through 2026.

Full Cycle Partners

end to end support from synthesis and process development to manufacturing and technical assistance.

Quality and traceability

Quality Management System based on ICH Q7, validated processes and full traceability across the production chain.

The result: Reliable materials and controlled processes that ensure consistency, scalability and trust in regulated markets.

Main applications
01

Parental, ophthalmics and lyophilized products.

Solutions for high demand applications requiring high purity and full traceability. APIs and regulated products under CGMP standards, with cleanroom operations for filling and packaging.

02

Vaccines and injectables.

Active ingredients and excipients for injectable formulations and vaccines. Benzethonium chloride (BZT) Benzalkonium chloride (BKC), USP grade

03

Nasal and respiratory sprays

Compounds for nasal and respiratory formulations. Cetylpyridinium chloride (CPC) for nasal sprays.

04

Anti-infectives and antimicrobials.

Active ingredients for the treatment of bacterial, viral and fungal infections. Chlorphenesin (CPH): bacterial/fungicidal

05

Excipients and pharmaceuticals formulations.

Functional components for drug formulation, including stabilizers, preservatives and lubricants. Quality Management System based on ICH Q7, with validated processes, qualified equipment and full traceability.

Solutions

Technical solutions for the industry

CGMP production

regulatory compliance with infrastructure in controlled environments (cleanrooms) and FDA/PMDA audits.

Quality system

aligned with ICH Q7, including process validation, equipment quantification and comprehensive documentation control.

Process integration

technology transfer and adaptation to production lines.

Regulatory support

guidance for compliance and operations under FDA and PMDA frameworks.

Scaling

design of reproducible processes from laboratory to commercial scale.

Support and partnership

More than a supplier, your partner in pharmaceutical development.

We collaborate with you in the selection, integration and optimization of ingredients and solutions for your pharmaceutical projects. 

Our team provides technical, regulatory and commercial support, ensuring consistent quality and regulatory compliance at every stage of your formulation and scale up.

CONTACT

Let’s talk about your project

If you’re developing or optimizing pharmaceutical products, let’s connect. We help you evaluate alternatives, solve technical challenges and bring your formulation to production under the highest quality standards.

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