| |
Integrity / Quality / Service / Compliance
Core Competencies: Over the Counter (OTC) pharmaceuticals, nutraceuticals and supplements
- FBP has invented new forms and found creative ways to put both monographed and new active ingredients into its current forms.
- A range of delivery vehicles and formulations can be considered in planning a category to specifically address the needs of the consumer.
- The process starts with customers at the concept stage to determine and define the brand strategy, the consumer need and the product attributes required to meet that need.
Research & Development: Beginning with Ideation, the art of bringing a new product to market involves a thorough understanding of the active ingredient’s properties in the delivery matrix. FBP’s knowledge of the actives and excipients used to manufacture the final product means that when the product is delivered it will perform as expected in terms of efficacy, shelf life, and taste. New delivery vehicles | Formulations | Stability Programs
- New delivery vehicles – FBP’s expertise extends to active ingredients and delivery forms that the company does not currently manufacture.
- Formulations – Stability and taste masking are the two most critical elements of product development. FBP’s knowledge of the materials and close working relationship with one of the pre-eminent flavor development companies in the country means that customers get a product that meets or exceeds expectations.
- Stability Programs – FBP capabilities also includes in-house ICH Q1A compliant stability programs designed to ensure delivery of a product that meets label claim throughout its shelf life.
 Products:
- Over the Counter (OTC) pharmaceuticals. FBP works primarily with monographed active ingredients and the forms as outlined in the USP. It also has the skills and capabilities to work with partners in development of NDA’s, ANDA’s, and SNDA’s by preparing and providing data required for these applications.
- Supplements and nutraceuticals. These classes of products are becoming increasingly important to the consumer; FBP is currently manufacturing products that compete in this category in all of its forms.
- Packaging is a critical attribute of the product, and FBP offers a wide range of packaging capabilities.
Regulatory Compliance:
- Making a drug product REQUIRES compliance with the regulations controlling the manufacture and distribution of the drug product. Customers need to know that their manufacturing partner is delivering a product that is compliant with those regulations in a cost effective manner. FBP minimizes the risk of marketing a drug by going above and beyond the minimum requirements of the regulations.
- The regulations now governing the manufacture and distribution of supplements are now much closer to those required for drug products. Customers need a supplier that is capable of compliance with these new regulatory requirements. FBP is already DSHEA compliant and ready to make safe effective compliant supplement products.
Innovation:
- Our R&D staff of formulation scientists will work with you to develop the products to meet your market objectives.
- A range of delivery vehicles and formulations can be offered to meet your objectives
|
Services:
Cooperative Ideation
- Product Development
- Formulation and flavor enhancement
- Stability
- Validation
Turnkey Contract Manufacturing
– concept to finished product
Multiple packaging options
Quality protocols
Regulatory expertise
Chemistry & microlabs
 Sample production capabilities
|
|
