Investor Presentation Full Year 2021
9
Investor presentation Full year 2021
WegovyⓇ supply update following cGMP issues at supplier
announced in December 2021
WegovyⓇ simplified manufacturing process
ㅎ
Ramp up ongoing
CO
H
Produce
Filling
API
Assemble Packing Freight Distribution Patients
device (inhouse)
(in house)
1
(inhouse)
CGMP
issue at
CMO
CGMP: Current good manufacturing practice; FDA: Food and Drug Administration; EU: European Union; CMO: Contract Manufacturing Organisation
•
•
Update on supply chain situation
Large global contract manufacturing organisation received
a 483 letter by the US FDA related to cGMP issues at
production site for Wegovy® syringes
Deliveries and manufacturing temporarily stopped
Close collaboration between CMO and Novo Nordisk to
address cGMP issues as fast as possible
Supply capacity in H1 2022 is now expected to be close to
the TRX level seen in the fourth quarter of 2021
Application to add an additional device to the marketing
authorisation for WegovyⓇ in EU
Still expect to be able to meet demand in the US in the
second half of 2022
Novo NordiskⓇView entire presentation