API Manufacture | GMP API Manufacturing

For large scale GMP API manufacturing, we have access to seven India-based sites. The main one used for Onyx Scientific is in Ratlam, which is supported by an R&D centre and technical team in Mumbai in addition to a project management team in the UK.

Our Ratlam site, which houses 22 plants, has over 320 reactors with sizes up to 11000 litres and an aggregate capacity of over 2000 MT p.a. The site boasts three dedicated and 15 multi-purpose blocks with powder processing and micronization facilities. Delivering batch sizes up to 1000 Kilograms, our 750-strong team offer a wide range of reaction capabilities.

So when scaling up your project, we can offer dedicated scientists, rapid internal tech transfer from the UK and instant capacity at Ratlam along with having the security of knowing we have additional plants and sites should your demand increase significantly. Furthermore, our solid manufacturing capability is supported by our QA team that maintain the highest level of quality standards across the site. In fact, 20% of our staff at the site are dedicated to quality.

Our parent company Ipca Labs has been manufacturing GMP APIs and supplying these commercial APIs to seven of the top big pharma companies for over 20 years and meet very high standards of EHS and QA compliance. Our commercial GMP API manufacturing sites in India have been inspected and approved by regulatory bodies including FDA, MHRA, SA MCC, TGA, Japan PDA to name a few.

For more information about our API manufacture and production services, please contact us today.

Large scale GMP API manufacturing