TBD Pharmatech - Pharmaceutical API CDMO

GMP API Development

GMP API development service aims to create Active Pharmaceutical Ingredients (APIs) in compliance with Good Manufacturing Practices (GMP). The objective is to ensure exceptional quality, safety, and efficacy of the APIs.

TBD’s in-house team offers a comprehensive end-to-end API technology development service, optimized for cost-effectiveness.

The process typically starts with route scouting or technology transfer and progresses through process development steps to culminate with the production ready technology for GMP-compliant batches of the required size.
Once a compliant API is developed, regulatory approvals are secured by submitting ASMF/DMF documentations to appropriate agencies. When market-ready then the API advances to commercial production.

Contract Development
TBD Photo Archives. Chemist working on site in Tartu

A series of steps to develop and control the process parameters whilst scaling up the activities.

To validate testing methods for starting materials, intermediates, and the final API product. The goal is to uphold the quality and safety of all compounds used or produced during manufacturing.

Accurate records and documentation ensure process traceability, guide manufacturing operations, document technical details, aid in quality control, and fulfil regulatory mandates. Such documentation is essential for upholding operational consistency, ensuring product integrity, and meeting regulatory standards.

Crucial for ensuring that every facet of the manufacturing process aligns with Good Manufacturing Practice (GMP) standards and specifications, the manufacturing of APIs are reliable, consistent, and compliant with regulatory requirements.

To provide comprehensive data on API quality and manufacturing, these master files are instrumental in streamlining the approval and commercialization steps within the generic GMP API development pipeline.

These studies expose the API to various environmental factors like temperature, humidity, and light to assess its shelf life and potential degradation pathways; to guarantee that the API maintains its quality, efficacy, and safety throughout its designated shelf life.

Originated from from completed in-house API development or through customer-led tech transfer. TBD can manufacture market-approved generics, cGMP innovative molecules required for early phase clinical trials, or any other custom small-molecules such as excipients, intermediates or impurities.


+ Trusted by Industry Leaders. Esteemed pharma industry leaders like Alfasan International, Dechra, Oskar Tropitzsch and more have placed their trust in us. We are proud to be the preferred partner in advancing human and animal healthcare solutions.

+ Proven Expertise. Our extensive portfolio showcases successful API development across a wide range of functions in veterinary and human pharma.

Quality and client focus

Compliant with GMP since 2008, always following the latest regulatory standards. Your projects are in safe hands. Solutions emerge from two-way communication.

End-to-end service

TBD’s skilled in-house team handles every aspect of your API development and manufacturing needs, from route scouting and regulatory support to commercial production.

International outlook

TBD is based in Tartu, Estonia, EU, but our client base extends globally. Experienced with EU, US, Asian, Australian and New Zealand regulatory agencies.

Have a project in mind? Let’s discuss!

Contact us!