Commercial APIs

Bachem produces one of the largest amounts of commercially available synthetic peptide active pharmaceutical ingredients (APIs) in the world.

From the 75 approved peptide APIs in new chemical entities (NCEs) and generics that are globally available, Bachem commercialized one third of these APIs.

Our Good Manufacturing Practice (GMP) facilities are located in Switzerland and the United States and are regularly inspected by Swiss medic, the FDA, EMA, and other local regulatory authorities in the world to ensure our operational excellence and quality.

Bachem strives to develop long-term partnerships with customers. The long-lasting experience and capability of manufacture drug substance in large quantities under GMP conditions as well as the strong regulatory background makes Bachem a preferred commercial partner.

 

 

What Bachem offers

With more than 50 years of experience in the development, production, and compiling data for Drug Master Files (DMF), we have built a reputation as a reliable GMP manufacturer of NCEs as well as for high-demand generic products.

We have the capacity to produce peptide APIs from gram scale up to annual quantities of hundreds of kilograms. Bachem’s quality management system covers the entire production process, from starting materials to production, packaging and delivery of the final product.

Commercial NCEs

Our partners trust in our support and guidance for the commercial supply of GMP-manufactured NCEs.

Commercial Generics

Our partners trust in the constant quality of our generic APIs to manufacture their drug products.

Why choose Bachem?

  • Customer centricity & service – At Bachem, we strive to give our customers an all-round positive experience – no matter who they are or where they are located.
  • Innovation and technology – Technological leadership and innovative strength have been the cornerstones of our success since the very beginning of our company.
  • Operational excellence and quality – Bachem is a leading and successful global player in the business of developing and manufacturing peptides and oligonucleotides.
  • People & culture – Our employees make the difference. Representing our corporate culture of passion and commitment, they are the foundation of our success.
  • Sustainability – We are committed to sustainability by taking responsibility towards our employees, the society, and the environment.

What our customers are saying

“I truly feel comfortable selecting Bachem as API partner for our complex formulation need. Bachem always comes with innovative research which make them stand tall in this highly competitive environment. Working with Bachem, I don’t recollect any points which were not resolved and we have to go open ended for our ANDA submission, their customer service support is indeed superb. I can say that Bachem knows science, Bachem knows regulatory requirements, Bachem knows service which gives ultimate peace of mind to us and we are always confident that we tied knot with perfect API partner.”

-Kushal Shah, Manager, Amneal Pharmaceuticals.

“Frankly speaking and without flattery, we have never experienced such a great level of perfection. Instead of describing all that we have seen or read about Bachem, it is much easier to state that we returned from our visit to Bachem with the highest level of admiration.”

– Big Pharma Company

“With Bachem we have a reliable supplier at our side since many years. Bachem hasn´t only a constant in quality and experience for manufacturing in Europe but also looks for solution in difficult times. We really appreciate the cooperation between both parties.“

– European pharmaceutical company

Commercial API news

Commercial API knowledge

Our Knowledge Center has a wide variety of tools and materials for peptide and oligonucleotide chemistry.

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Further topics of interest

Commercial
Generics

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GMP
Production

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Quality and
Regulatory

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