Committed to Providing Products and Services Meeting Latest Global Quality and Safety Standards and Regulations
At Phyton, we continuously strive to improve all of our systems and processes in order to enhance the quality and safety of our products and services. We endeavour to not only meet the changing needs of our customers but to exceed customer expectations in all aspects of our business.
Our robust quality management and compliance systems are routinely monitored and reviewed to ensure we always satisfy all applicable specifications, regulations and quality standards in the development, manufacture and supply of cGMP active pharmaceutical ingredients and starting materials. Phyton has a strong performance history of meeting the requirements of regulatory agencies.
Product Submissions and Approvals
From starting material through to finished API, Phyton’s highly-skilled Quality Control and Quality Assurance teams in Germany and Canada ensure our APIs are manufactured and tested under strict GMP and meet USP/EP/JP compendia requirements.
Our Regulatory Affairs team at Phyton compiles high-quality registration documents. They are involved in all aspects of the registration process in order to ensure complete and successful registrations in several countries. Phyton holds the following registrations:
|Paclitaxel from Fermentation||Semi-Synthetic Paclitaxel||Docetaxel Anhydrous|
|US DMF, #25525||US DMF, #16374||US DMF, #24675|
|EU CEP, R1-CEP 2011-324||EU CEP, R1-CEP 2008-077||EU CEP, R0-CEP 2012-105|
|Canadian DMF, #2016-135||Canadian DMF, #2002-027||Canadian DMF, #2013-131|
|Japan DMF, #224MF10111||Korea DMF, #20121011-68-A-265-13||Japan DMF, #224MF10168|
|Korea DMF, #20130614-68-A-278-15|
Facility Registrations & Inspections
Phyton’s facilities in Germany and Canada have successfully been inspected by multiple regulatory agencies and comply with international GMP requirements, including:
|Phyton Biotech, LLC||Phyton Biotech, GmbH|
Health Canada DEL: 102155
Written Confirmation: 67771B0D
State Social Services Agency Schleswig-Holstein
Certificate of GMP Compliance of a Manufacturer, DE_SH_01_GMP_2017_1011
|Health Canada: October 2016, October 2014||State Social Services Agency Schleswig-Holstein: March 2017, March 2014, March 2011|
|US FDA: September 2017, October 2014, January/February 2012||USFDA: July 2016, September 2013, November/December 1998|
|Korean FDA: June 2012||Korean FDA: January 2013|
|EDQM: May 2011||EDQM: March 2017|
|TGA: August 2010|