BENUVIA MANUFACTURING
SERVICES & CAPABILITIES
R&D and Chemistry Services
Excellence in custom synthesis, process development, optimization and challenging chemistries
- Well qualified Ph.D. level research and development team.
- Experienced clinical development team in drug discovery and development.
- Strong expertise in highly complex reactions, purification techniques and isolation of highly pure natural products.
- Expertise in optimizing existing synthetic routes or developing alternative schemes to achieve cGMP processes.
- Capability to run custom synthesis from milligram to multi-kilo scale including purification capabilities (distillation, crystallization, and chromatography)
API Manufacturing Capabilities
Comprehensive production capabilities from grams to multi-kilograms under strict cGMP guidelines
FDA-inspected site for manufacturing, packaging and testing of Active Pharmaceutical Ingredients
- Gram to multi-kilogram API scales for high value low volume NCEs, niche Generic and Cannabinoid products.
- Ability to work on Controlled Substances with Schedule I to V manufacturing license.
- Unique combination of deep chemistry and API manufacturing expertise, fit-for purpose equipment and facility and close partnership with customers to enhance customer service and quality.
- Seamless transition and proven ability to scale-up from lab to commercial manufacturing.
- Strict environmental monitoring of manufacturing space.
Formulation, Fill and Finish Capabilities
Provides Reliable, Safe and Efficient cGMP Formulation and
Filling Services From Clinical to Small Scale Commercial Batches
We can accelerate the development of a finished dosage form by integrating an API and/or dose manufacturing programs
Benuvia Manufacturing offers integrated formulation development services for in-house and external API sources:
- Proprietary Formulation Development
- Feasibility Studies
- Excipient Compatibility
- Product/Process Optimization
- Process Scale-Up & Technology Transfer under cGMP
- Simple and complex dosage forms
- Novel formulations for new or existing products
- Controlled or sustained release formulations
Our fully integrated solutions shorten the
time and lower the cost of drug development and manufacturing
Benuvia Manufacturing offers the following filling services:
- Oral liquid solutions, with automated fill capabilities
for high precision liquids filing into bottles - Liquid inhalation aerosols (pMDI)
- Batch size scaled for clinical through commercial
- Able to handle light and oxygen sensitive products
Analytical and Stability Testing
Method Development with capabilities to develop and validate test methods
to support the release of Raw Materials, Drug Substances and Drug Products
Modern capabilities including High Performance Liquid Chromatography (UPLC, HPLC), Gas Chromatography (GC), Mass Spec, UV, FT-IR, TOC, Spray Pattern, Droplet Size, Plume Geometry, Spray Actuation, Content uniformity and USP compendial Testing.
Extensive variety of instruments
Stability Programs
- 20 Stability Chambers
- Meets ICH guidelines for drug substance and drug product
- Offers accelerated, intermediate & long-term programs
- Stability testing and reporting using iStability data reporting software
- Develops stability protocols, provides data & trend analyses as well as stability reports
| ICH Compliant Chambers |
|---|
| 40°C/75% RH |
| 25°C/60% RH |
| 5°C/Ambient RH |
| 30°C/65% RH |
Quality Systems
Regulatory and Audits
