Corden PharmaChem’s manufacturing facilities in Ireland & Belgium offer reliable, cost effective world-class custom pharmaceutical development and manufacturing capabilities as well as a number of high quality generic active pharmaceutical ingredients.

We conduct commercial cGMP manufacturing of active pharmaceutical ingredients and advanced intermediates for clinical trial supplies and commercial products. We offer big pharma calibre facilities, extensive regulatory experience, and a successful track record of FDA inspections. Moreover, we are uniquely suited to provide the full spectrum of cGMP synthesis and chemical manufacturing services, from production of early stage clinical trial materials to product launch and commercialization.

APIs manufactured to cGMP standards for clinical research or commercial sale must meet requirements for identity, strength, quality and purity. Our strength in process research and scale up, coupled with our wide range of cGMP synthesis capabilities, is well known in the industry. We are uniquely suited to handle your cGMP manufacturing needs seamlessly from grams to metric tons and through all phases of clinical trials without the need for technology transfer to another company. We manufacture bulk APIs and advanced synthetic intermediates to support clinical trial studies in various stages of product development, including Phase I through Phase III clinical trials. We manufacture commercial APIs or key intermediates in multi-kilogram to metric-ton quantities.

We have manufactured active pharmaceutical ingredients and intermediates in accordance with cGMP regulations since 1976. Our cGMP culture, procedures, and FDA-registered facilities are frequently audited by pharmaceutical companies and their regulatory consultants, making us a tested and proven partner.

The following standard documents are made available to customers with their products (automatically or on request):

• Specifications and certificates of analysis.
• Production procedures and master batch records for the laboratory, pilot scale and production scale. These procedures include the descriptions of the in-process controls, a list of the critical parameters for the validation, and calorimetric safety data, among others.
• Batch log records and batch documentation (may be reviewed at Corden PharmaChem sites).
• Development reports.
• Process validation plans and reports (may be reviewed at Corde PharmaChemsites).
• Annual product reviews.