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Contract Manufacturing - API

World-leading drug substance producer and active pharmaceutical ingredient manufacturer

Consort Medical has been an active pharmaceutical ingredient (API) manufacturer for over 30 years.  Combined with our development and supply services, we have the facilities and expertise to take an API from pre-clinical through to commercial scale manufacture.

Expert in active pharmaceutical ingredient manufacturing area

From kilo lab to pilot plant to commercial scale manufacture; we help discover, develop and optimise complex active pharmaceutical ingredient manufacturing processes and analytical methods. We can support clients to provide a smooth transition from drug substance development through to commercial API manufacture.

We are flexible and offer CMO (tech transfer) and or CDMO services for your drug substance or API requirements. Working in partnership, we strive to deliver a rapid, cost effective and compliant solution in an ever-changing regulatory and economic environment, giving our customers assurance of supply with API’s that require complexity.

Safety and Quality are fundamental and integral part of our business.  Our manufacturing facilities meet the highest standards and have been inspected by MHRA, FDA and other regional regulatory bodies, as well as many customer audits. All of our APIs, both generic and proprietary, are manufactured according to cGMP and appropriate regulatory frameworks. We supply API’s across the globe and are one of the biggest producers of Flurbiprofen.

We believe in a culture of continuous improvement

Our CMO offering in API manufacturing services  focuses on operational excellence and continuous improvement ensuring processes are efficient and effective.

As a market leader in active pharmaceutical ingredient manufacturing we focus on pushing the capabilities of our industry forward, while sharing the benefits with all of our stakeholders and partners.

  • Highly-skilled staff with yellow, green or black belt lean six sigma certifications
  • Experienced workforce in manufacture of drug substance and API’s
  • Reduction of manufacturing process cycle times, delivering an increased output of over 20% for the API
  • Increase in production yields by over 15%
  • Reduction in the cost of manufacture of API
  • Standardised turnaround times

Our key capabilities as active pharmaceutical ingredient suppliers

Manufacturing:

  • Our cGMP manufacturing plants  in Cramlington are dedicated to API commercial-scale production with approval from all major regulatory authorities
  • Total contract active pharmaceutical ingredient manufacturing capacity of >120m3 which includes range of vessels, filter driers and clean rooms.
  • Licence for controlled drug production and flexibility to handle and manufacture potent drug classes

Regulatory and support  services for API manufacture

  • Supply chain management, sourcing and qualification
  • Regulatory expertise and support
  • Compilation and submission of Drug Master Files (DMF)
  • Support for IND applications
  • Secure storage and supply of controlled drugs

30 years of generic API manufacturing experience

Consort is a global leader in the production of generic APIs in areas such as antidepressants, narcotics and anaesthetics.

We supply the following generic products worldwide:

 

 Product Name CAS No. Therapeutic CategoryRegistration
Sodium Flurbiprofen (Pharmaceutical grade)56767-76-1OpthalmicsUSDMF

ASMF

Flurbiprofen (racemic)5104-49-4NSAIDUS DMF

CEP

Japan DMF, Canada DMF, China DMF, Taiwan DMF

S(+)-Flurbiprofen51543-39-6NSAIDN/A
R(-)-Flurbiprofen51543-40-9VariousN/A

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