Highly Potent Active Pharmaceutical Ingredients

Highly Potent Solutions Overview Broad Range of Oral Technologies
Extensive Suite of Oral Manufacturing Capabilities Facilities With Potent Handling Capabilities

sa��ʴ�ý��ҳ��is the #1 Drug Development, Delivery and Supply Partner for the global pharmaceutical and biotech industries.

With over 20 years of experience in potent handling and over 90 years in pharmaceutical delivery solutions, sa��ʴ�ý��ҳ��offers integrated analytical, development, manufacturing, and for highly potent products.

Catalent’s long history of expertise in handling high potent molecules includes more than 300 Category 3 & 4 compounds across 12 sites in the global sa��ʴ�ý��ҳ��network, including hormones and cytotoxics. sa��ʴ�ý��ҳ��has also recently acquired a state-of-the-art facility in Greenville, N.C. which features fit-for-scale capacity with extensive potent handling capabilities.

TECHNOLOGY	POTENT (10 to 1UG/M3-OEL)	HIGHLY POTENT (1UG/M3 or less)	CYTOSTATIC	CYTOTOXIC	HORMONES	DEA I-V
TECHNOLOGY	POTENT (10 to 1UG/M3-OEL)	HIGHLY POTENT (1UG/M3 or less)	CYTOSTATIC	CYTOTOXIC	HORMONES	DEA I-V
Oral Solids	Yes	Yes	Yes	No	No	Yes
Softgel	Yes	Yes	Yes	Yes	Yes	Yes
Zydis	Yes	Yes	Yes	No	No	Yes
Micronization	Yes	Yes	Yes	Yes	No	Yes
Spray Drying	Yes	Yes	No	No	No	No
Analytical	Yes	Yes	Yes	Yes	Yes	Yes
Development	Yes	Yes	Yes	Yes	Yes	Yes
Manufacturing	Yes	Yes	Yes	Yes	Yes	Yes
Clinical Packaging	Yes	Yes	Yes	Yes	Yes	Yes
Clinical Supply	Yes	Yes	Yes	Yes	Yes	Yes

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HIGHLY POTENT SOLUTIONS OVERVIEW

From API optimization, particle size optimization and formulation services, to drug delivery technology and final dose form design services, sa��ʴ�ý��ҳ��can help you at the earliest stages of the drug development process and provide end-to-end solutions to accelerate your programs to clinic and to market, utilizing our broadest expertise, best technologies and rigorous science.

Global supply chain expertise
- Development
- Analytical services
- Delivery technologies
- Clinical and commercial manufacturing
- Packaging services
- Clinical storage and distribution
Highly potent, hormonal, cytotoxic compounds
Multiple oral dose form technologies and services
Robust controls for special handling and containment
- Engineering and PPE controls
- Comprehensive risk assessment processes
- Highly-trained and experienced personnel
- Expertise in special handling protocols
Controlled substance handling (DEA I-V)

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BROAD RANGE OF ORAL TECHNOLOGIES

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EXTENSIVE SUITE OF ORAL MANUFACTURING CAPABILITIES

Tableting and capsule filling
Particle Size Engineering
Hot-Melt Extrusion
sa��ʴ�ý��ҳ��Spray Drying Technology
High-shear and wet granulation processing, solvent-based capability
Fluid-bed processing, Wurster coating
Compression and encapsulation
Extrusion/spheronization
Blending and milling
Compression and encapsulation
Extrusion/spheronization
Blending and milling

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FACILITIES WITH POTENT HANDLING CAPABILITIES

Our high potent handling facilities have strong track records for both quality and regulatory compliance.

Oral Solids Development and Manufacturing

Softgel Technologies

Stand-Alone Analytical Services

Raleigh, North Carolina

Clinical Supply

Get an up-close look at these sites and more, explore Catalent’s 360⁰ virtual tours.

All molecules have a challenge. We have a solution. For an expert consultation of how we can assist with your highly potent molecule challenges contact us and an expert will get back to you shortly.

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