2 /J u n -2 0 1 9 /V er si o n 1 .0 Certificate Avient Colorants Singapore Pte Ltd 8 Third Chin Bee Road Jurong Industrial Estate 618684 Singapore Singapore Scope Administration, Site management, Manufacture, Laboratory, Procurement, Maintenance, infrastructure, Warehouse and Transport Normative base EN ISO 13485:2016 Medical devices – Quality Management System Reg. no. 45483 Validity 01. 03. 2022  – 28. 02. 2025 Issue 01. 03. 2022  A.Grisard, President SQS F.

ISO13485認証取得の4拠点で製造し、グロー バルで同品質の製品を安定的に供給致します。規制対応 • • • 評価試験：- ISO 10993-1 - USP および (Class VI) - 欧州薬局方 モノグラフ 3.1.3/ 3.1.5 (ポリオ レフィン系包装材) - USP (ポリエチレン) - ICH Q3Dに準拠した元素不純物分析 DMF（Type III）および Device Master File 登 録済み 米国FDAおよびEUの食品接触規格 ヘルスケア用途に制限ありー下記参照詳しくはAvientにお問い合わせください。a) 米国食品医薬品局（FDA）または国際標準化機構（ISO）により「インプラント」機器として分類される医療機器、または米国薬局方（USP）または ISO 規格で定義される「パーマネント」 機器、または (b)EU指令90/385/EECの改正で定義された能動埋込型医療機器、または (c)EU指令93/42/EECの改正で定義された「長期」使用のための医療機器。

U KAS MANAC〔M〔N丁 SYSTEMS 0005 、端；薰；; HCSGS 13485 2016 Olin ：氨 城心〔找n心亡〔 ．．八 护、产、八 j 丹月六户 八八月户 八月月‘、 ）如》 称资熨面蔚若三 「｛羹 StS55G S GSlfS5SG56SGSGSGSGSGSG5G5 f5 嚷i羹羹巍熊燕鬓；；奎忿 rage I Oil;；燕七 :终 sds 0Gs、 山5互 0s's""“ 刀之：J"‘、 ,slttiGsti.' China has been assessed and certified as meeting the requirements of 麟 ISO 13485:2016 EN ISO 13485:2016 ’骥鑫馨瓤） For the foiowing actratEes Design and manufacture of medical grade thermoplastic elastomers for non-active medical devices and active medical devices 遴；舞蒸；撇蒸 (non-implantable) ：护、：：于 b入沙黔娜；舞睡莎：器器舞蟒檬非拟拐称群亘爸竺舀‘。5‘冲」之七乃竿月 rf』J枯：“号淤，石 「3 ;:;This certificate is valid from 20 February 2021 until 19 February 2024 S SGSGS and remains valid subject to satisfactory surveillance audits Re certification audit due before 6 January 2024 Issue 6.

C e rt if ie d M an ag ement System s by Sw itze rla nd Certificate The SQS herewith attests that the organisation named below has a management system that meets the requirements of the normative basis mentioned. Normative base EN ISO 13485:2016 Medical devices – Quality Management System Reg. no. 37081 Validity 01.03.2022 – 28.02.2025 Issue 01.03.2022 Swiss Made Swiss Association for Quality and Management Systems (SQS) Bernstrasse 103, 3052 Zollikofen, Switzerland sqs.ch F.

Some have additional certifications such as ISO 13485, ISO 14000, ISO 22000 and other third-party certified standards such as Responsible Care® and IATF. https://www.avient.com/company/policies-and-governance/it-systems-use-policy 9 10 Annex 1 - ISO 13485 certification for Mevopur manufacturing sites North America & EMEA. Avient Colorants Sweden AB in Malmoe and Avient Colorants USA LLC in Lewiston, Maine are Medical Centers of Competence with an external ISO 13485 certification.

C e rt if ie d M an ag ement System s by Sw itze rla nd Certificate The SQS herewith attests that the organisation named below has a management system that meets the requirements of the normative basis mentioned. Normative base EN ISO 13485:2016 Medical devices – Quality Management System Reg. no. 45484 Validity 01.03.2022 – 28.02.2025 Issue 01.03.2022 Swiss Made Swiss Association for Quality and Management Systems (SQS) Bernstrasse 103, 3052 Zollikofen, Switzerland sqs.ch F.

Homepage // News Center // Avient Attains ACC Responsible Care® 14001 Global Certification for Environmental, Health, Safety, and Security Excellence Obtaining the RC14001® certification is unique as it encompasses security, product safety, and transportation elements, setting itself apart from the individual ISO 14001 and ISO 45001 certifications.” Additionally, this certification follows Avient’s recent Gold Rating certification achievement from EcoVadis, a globally renowned sustainability ratings platform, for its dedication to sustainability, ethics, and responsible business practices.  

PHARMACEUTICAL PACKAGING OEM V I A L S , B O T T L E S & C O N T A I N E R S • Raw materials pre-tested to USP 661.1 and ICHQ3D guidelines • Stabilization during molding and sterilization processes for both opaque and transparent polymer materials • Certified formulations available globally • Offered pre-tested raw materials and produced in an ISO 13485 certified site, minimizing risk across the pharmaceutical value chain • Delivered specialized formulated solutions to meet stringent pharmaceutical packaging requirements • Provided global formulations transferrable from our three ISO 13485 certified facilities Mevopur™ Healthcare Concentrates KEY REQUIREMENTS WHY AVIENT? AVIENT SOLUTION CERTIFICATION + AVAILABILITY LEARN MORE © 2021, Avient Corporation, All Rights Reserved https://www.avient.com/products/polymer-colorants/solid-color-masterbatches/mevopur-custom-colors-and-formulations

Is there an Environmental Management System (EMS or/and ISO 14001 certifications) in place? Varies by Site; refer to ISO Cert https://www.avient.com/company/policies-and- governance/global-iso-certificate-library How often are 3rd party audits conducted? IATF and ISO 13485 managed within ETQ Reliance.

Minimum requirements are adopted from the ISO 9001 standard. Avient shall communicate additional requirements regarding automotive (IATF 16949) and healthcare (ISO 13485) applications based on the raw material’s end-use application. This document is property of Avient Corporation and may not be reproduced or communicated to third parties without authorization. 3.0 Supplier Management 3.1 Supplier Quality Management System Avient expects its supply base to maintain a certified QMS at all of its locations and those of its affiliated companies in accordance with the requirements of ISO 9001, ISO 13485, or IATF 16949 (depending on supplier commodity), as applicable.