Seqens North America

Seqens North America Seqens North America offers its API clients a reliable and cost-effective, domestic source for their API manufacturing needs.

Seqens offers you everything you need from initial process research to commercial manufacturing. We have more than 20 years of experience in chemical manufacturing, which has enabled us to develop deep expertise in custom NCEs, generic APIs, and custom manufactured fine chemicals. Seqens combines the responsiveness of a small company with the capacity and capabilities of a much larger one. This un

ique combination enables us to:

Adapt and respond quickly and effectively to your development needs
Deliver products on-time and within agreed specifications
Offer competitive pricing and a true ease of doing business
Key Company Facts:
10 DMF’s (Drug Master File) filed currently-
4 more in 2012; 6 commercial products
Scaled up over 150 processes/chemistry to plant scale
Operate 2 Massachusetts-based facilities
Over 90 employees

02/03/2023
The role of ICH in helping to raise the quality and safety of APIs in drug development
09/15/2022

The role of ICH in helping to raise the quality and safety of APIs in drug development

This article addresses the role of ICH as a global standards body and how to ensure compliance in API manufacturing

Manufacturing APIs for Injectables Requires a Safety-First Approach: Maintaining Clean Room Operations is Key to Safety,...
09/13/2022

Manufacturing APIs for Injectables Requires a Safety-First Approach:
Maintaining Clean Room Operations is Key to Safety, 5 Best Practices to Follow

Understanding the critical role of cleanroom operations when manufacturing APIs for injectable drugs

What Has Changed in Method Development and Validation for Pharmaceuticals and Why You Need to Know: The 4 best practices...
09/12/2022

What Has Changed in Method Development and Validation for Pharmaceuticals and Why You Need to Know: The 4 best practices that assure robust method validation

Why the traditional approach to developing DMFs, NDAs and ANDAs is no longer acceptable—and what you can do today

The Role of ICH and How to Meet Quality Guidelines in API Manufacturing: 5 Steps to Meet ICH Guidelines
09/09/2022

The Role of ICH and How to Meet Quality Guidelines in API Manufacturing: 5 Steps to Meet ICH Guidelines

This article addresses the role of ICH as a global standards body and how to ensure compliance in API manufacturing

The Many Reasons to Choose an Integrated CDMO for Your ProjectsWhy demand is high for integrated CDMO services
09/08/2022

The Many Reasons to Choose an Integrated CDMO for Your Projects
Why demand is high for integrated CDMO services

What value does a fully integrated CDMO provide?

What are the 10 best practices in API R&D?
09/02/2022

What are the 10 best practices in API R&D?

Why and how stellar R&D and an integrated CDMO provide the fastest road to API approval and first-mover advantage.

What CDMO Capacity Refers to and What to Look ForOvercapacity & Under-capacity are Red Flags
09/01/2022

What CDMO Capacity Refers to and What to Look For
Overcapacity & Under-capacity are Red Flags

Having trouble finding a CDMO with capacity for your project? What you need to know about managing capacity.

APIs: the Superheroes of Drug DevelopmentAccelerating Your Drug Development Projects with Proprietary APIs
08/31/2022

APIs: the Superheroes of Drug Development
Accelerating Your Drug Development Projects with Proprietary APIs

This article describes the value of proprietary APIs and how to work with a CDMO to best leverage them

The Fastest Road to API Manufacturing is Exceptional R&DThe 10 best practices in API R&D
08/26/2022

The Fastest Road to API Manufacturing is Exceptional R&D
The 10 best practices in API R&D

Why and how stellar R&D and an integrated CDMO provide the fastest road to API approval and first-mover advantage.

CDMOs can maintain a collaborative, long-lasting relationship with sponsors.
08/25/2022

CDMOs can maintain a collaborative, long-lasting relationship with sponsors.

Two of the most gratifying things I’ve experienced in my two decades of running a CDMO have been the loyalty of my staff, and the collaborative, often lasting relationships we have built with sponsors. Internally, the majority of Seqens CDMO NA’s (formerly PCI Synthesis) scientists, project mana...

Address

9 Opportunity Way
Newburyport, MA
01950

Opening Hours

Monday 9am - 5pm
Tuesday 9am - 5pm
Wednesday 9am - 5pm
Thursday 9am - 5pm
Friday 9am - 5pm

Telephone

(978) 462-5555

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