Company Info

Lyne Laboratories, Inc.

CDMO

Overview

Lyne Laboratories is focused on the development and manufacturing of ANDA drugs as well as on supply chain management. Its mission is to offer drug development and manufacturing solutions to select companies that are focusing on creating win/win business partnerships. The company was founded by Robert C. Crisafi in 1965. Lyne is specialized in the manufacture of oral liquids, powders, semi-solids, tablets and liquid unit-dose packaging. It also offers manufacturing services for scheduled drugs and alcohol formulations. The company’s services include: Clinical manufacturing – Late Stage Phase III, Technical Transfer, Commercial manufacturing, Analytical services, ICH stability programs, Validation services, Alcohol formulations, etc. Its developmental services include: Pre-Formulation and Formulation Development, Process Development, Process Scale-Up, Methods development/validation, Regulatory support, Engineering batches, etc.

Company Services

Services/CapabilitiesCDMO

+ Development Services

Analytical Development & Validation
Bioanalytical Services
Preformulation/Formulation
Process Development & Validation
Raw Material Testing
Scale Up/Tech Transfer
Stability Testing

+ Drug Product Manufacturing

Lyophilized Products Manufacturing

+ Drug Substance Manufacturing

Controlled Substances