Versatile and fast-paced capabilities
Together with our affiliated companies, we have the facilities to respond globally
to varying needs, from small quantities to larger volumes.
Our plant has proven itself in the large-scale manufacturing of fine chemicals,
advanced intermediates and active ingredients. We are well known for the
large-scale synthesis of complex organic molecules, produced under stringent
regulatory conditions.
Thanks to our dedicated and versatile multi-purpose facilities, we have the
ability and flexibility to take on a wide range of custom manufacturing
projects. Our plant is able to produce FDA-approved products and is regularly
inspected for quality assurance by our customers and governmental agencies.
The custom manufacturing process
From inquiry through full production:
Step 1: Customer contacts Koffolk either by
email/fax/phone
Step 2: Koffolk’s development staff will come back to the potential customer
within 5 business days to discuss the inquiry
Step 3: If there is a mutual agreement, the molecule is then sent to the Koffolk
Labs for table-top production
Step 4: Once process is refined, lab batch is prepared and sent to customer
Step 5: Once customer approves lab batch, process is scaled up to Koffolk pilot-batch plant
and product again sent to customer for approval
Step 6: Once customer approves pilot batch, the process can now move to full-scale
production
Equipment and manufacturing services
We offer a fully equipped and versatile pilot plant that is compliant with
cGMP processes, FDA and EU regulations. Through our plant, we provide our
customers with analytical services, validation methodology, stability assays,
quality control and many other techniques that can help lead to product
registration.
Materials that we regularly work with include:
- Acrylonitrile
- Aluminum chloride
- Ammonia gas
- Carbon monoxide
- Concentrated mineral acids and alkalis
- Dimethylsulfate, diethyl sulfate
- Hydrogen
- Hydrogen chloride gas
- Phosphorus oxychloride
- Sodium cyanide
- Sodium hydride
- Sodium methoxide (solid)
- Thionyl chloride
- Trimethylamine gas
