Who we are
Lyne has been providing contract manufacturing services to mid-size and large ethical pharmaceutical companies, small biotech start-ups, and virtual companies for more than 35 years. We specialize in the manufacture of oral liquids, powders, semi-solids, tablets and liquid unit-dose packaging. Lyne also offers manufacturing services for scheduled drugs and alcohol formulations.
Lyne’s services include:
- Clinical manufacturing – Late Stage Phase III
- Technical Transfer
- Commercial manufacturing
- Analytical services
- ICH stability programs
- Validation services
- Regulatory support for NDAs & ANDAs
- Hospital unit-dose liquid packaging
- Scheduled drugs
- Alcohol formulations
Lyne offers a wide range of contract manufacturing services from our modern, cGMP-compliant facility including compounding, filling and packaging. We offer liquid filling flexibility with up to eight different filling lines. Lyne’s high-speed rotary fillers have the capacity to fill up to 250 containers a minute. Batch sizes can range from 100 liters pilot size to 10,000 liters commercial.
Lyne has the expertise to meet all regulatory requirements of product development and manufacturing including technology transfer, pilot and engineering batches, commercial services validation and commercial batches. Lyne has a successful track record with FDA pre-approval and post-validation inspections for new and abbreviated drug applications, CMC sections, clinical supplies for late stage Phase III studies, cGMP compliance, and regulatory services.
Lyne was an early pioneer of unit-dose packaging for liquids and offers this specialty package option in various cup materials.
For more information, please contact us.