Committed to Providing Active Pharmaceutical Ingredients, Products & Services that Meet 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.

Submissions and Approvals for Active Pharmaceutical Ingredients

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

GMP Production 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
DUNS: 244283781
FEI: 3006110823
Health Canada DEL: 102155
Written Confirmation: 67771B0D
DUNS: 342498946
FEI: 3002807883
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