Vision & Mission
Build a Better Future, Together
At Tulex Pharmaceuticals, we work closely with innovative companies to assist with drug design, delivery, manufacturing and FDA compliance.
Who We Are
A technology driven specialty pharmaceutical company with a team of highly experienced and proven scientists.
What We Do
Focused on developing and marketing innovative technology and complex drug products for oral administration.
How We Do It
Fully integrated facility including R&D laboratories and cGMP solvent capable manufacturing plant.
Our Accomplishments
Team’s prior experiences include 25+ IND submissions, 7 NDA approvals via (505b2) and 30+ANDA approvals in 7 First to File arena, 25+ Extended-Release products
FDA Compliance
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November 2017
March 2018
December 2019
August 2020
Our Quality System
Our Quality System supports the development and manufacture of pharmaceutical drug products throughout the product life cycle. Which includes:
Pharmaceutical Development
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Commercial Manufacturing
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Technology Transfer
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Post Market Reporting
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Our Quality System includes critical concepts such as Quality, Quality Risk Management, and Investigations, Corrective and Preventive Action (CAPA), Change Control, Training, and Six Systems Inspection Model.
Our Quality Unit is an autonomous group that directly reports to the CEO and President of the company.
