GMP-certified excipient production sites

All excipient production sites with GMP certification

In the pharmaceutical world, the term GMP, or Good Manufacturing Practice, plays quite a big role. In this article, we explain what GMP stands for in general, and specifically for the pharmaceutical excipient industry. Moreover, it is shown which organizations perform testing and inspection, and how the GMP-certification process works. To get a good overview of the currently GMP-certified excipient production sites, we have marked all of them in an interactive map with additional information available.

What is GMP exactly?

“Good manufacturing practices (GMP) are the practices required in order to conform to the guidelines recommended by agencies that control the authorization and licensing of the manufacture and sale of food and beverages, cosmetics, pharmaceutical products, dietary supplements, and medical devices. These guidelines provide minimum requirements that a manufacturer must meet to assure that their products are consistently high in quality, from batch to batch, for their intended use. […] The World Health Organization (WHO) version of GMP is used by pharmaceutical regulators and the pharmaceutical industry in over 100 countries worldwide, primarily in the developing world. The European Union’s GMP (EU-GMP) enforces similar requirements to WHO GMP, as does the FDA’s version in the US. Similar GMPs are used in other countries, with Australia, Canada, Japan, Saudi Arabia, Singapore, Philippines, Vietnam and others having highly developed/sophisticated GMP requirements.” (Wikipedia)

In the excipient industry, EXCiPACT has an important role:

Regulators require excipient users to qualify their suppliers based on GMP/GDP audits and they have indicated that third party auditing of suppliers is acceptable if a creditable certification body issues certificates and audit reports by employing qualified auditors who are demonstrably credible in suitable GMP/GDP standards and in the needs of the pharmaceutical industry. EXCiPACT asbl is a non-profit organisation that owns and manages oversight of such an independent, high quality, third party Certification Scheme available to pharmaceutical excipient manufacturers and distributors worldwide.

Which certification bodies are working with EXCiPACT?

There are several certification bodies working with EXCiPACT, these are: SGS (global); AENOR (global); AJA (global), blue inspection body (global), DQS (mainly Europe and Mid-East); BV (mainly China), and Certiquality (mainly Italy).

The Certification Scheme can only be undertaken by a Registered EXCiPACT Certification Body employing a Registered EXCiPACT Auditor. The Certification process contains eigth steps in total.

Certification Scheme EXCiPACT
EXCiPACT GMP Certification Process

This is the first step:

“The Supplier selects a Certification Body from the approved list and provides them with information to issue a cost quotation, audit timetable and duration for a 3-year certification audit. This reflects the supplier’s audit scope and the organisational and operational complexity of the specified site.”

The remaining steps of the certification process can be seen here or in the graphic on the right side, which can be expanded.

The detailed process may vary with each Registered EXCiPACT Certification Body.

Developed by excipient suppliers and users, the Scheme’s core objectives are (i) to demonstrate a safe, reliable, transparent pharmaceutical supply chain, and (ii) to reduce the audit burden, costs and resources for manufacturers, distributors and users of pharmaceutical excipients without compromising quality. The Scheme comprises the following components:

  1. GMP standard for excipients as an annex to ISO 9001:2015
  2. GDP standard for excipients as an annex to ISO 9001:2015
  3. Certifying Body competency qualification as an annex to ISO 17021-1:2015
  4. Auditor competency qualification as an annex to ISO 17021-1:2015.

Have a look at all the pharmaceutical excipient production sites with EXCiPACT Certification here:

See the GMP-certified production site’s of our partners:

NameCertification BodySite LocationScopeIssue DateExpiry DateRegistration NumberCertified Since
Air Liquide Austria GmbHAJA (Global)Schwechat, AustriaGDP, GMP19. Nov 1919. Nov 22AJAEU/20/00919. Nov 19
Air Liquide Benelux IndustriesDQS GmbHMarchienne-au-Pont, BelgiumGDP, GMP02. Aug 1901. Aug 22527184 EXCI02. Aug 16
Air Liquide France Industrie Grande SyntheSGSGrande-Synthe, FranceGMP12 January, 202111 January, 2024FR17/8184268112 January, 2018
Air Liquide France Industrie Moissy CramayelSGSMoissy Cramayel, FranceGMP12 January, 202111 January, 2024FR17/8184266512 January, 2018
Air Liquide France Industrie, Feyzin Activité LiquideSGSFeyzin, FranceGMP12 January, 202111 January, 2024FR17/8184264612 January, 2018
Air Liquide Italia Produzione srlCertiqualityCastelnuovo del Garda, Verona, ItalyGMP11 December, 202010 December, 2023P451311 December, 2020
Air Liquide Italia Produzione srlCertiqualityLimito Di Piotello, Milan, ItalyGMP19. Nov 2018. Nov 20P448519. Nov 20
Air Liquide Italia Service SRLCertiqualityRodano (Milano), ItalyGMP25. Aug 2024. Aug 20P445225. Aug 20
AL Air Liquide España, S.A.AENORCabanillas del Campo (Guadalajara), SpainGDP, GMP16. Sep 2016. Sep 23EXC-2020/00116. Sep 20
AL Air Liquide España, S.A.AENORMadrid, SpainGDP, GMP16. Sep 2016.09.2020EXC 2020/00216. Sep 20
Armor Proteines S.A.S. (ARMOR PHARMA™)SGSLoudéac, FranceGMP08. Aug 1907. Aug 22FR16/184232108. Aug 19
BASF Advanced Chemicals Co., LtdBureau Veritas ChinaPudong, Shanghai, PR ChinaGMP05 March, 202004 March, 2023CNBJ20200105 March, 2020
BIOGRUND GmbHDQS GmbHHünstetten, GermanyGDP, GMP26 June, 201925 June, 2022296948 EXCI13 December, 2013
Chemische Fabrik Budenheim KGSGSBudenheim, GermanyGDP, GMP14. Apr 2013. Apr 23DE16/81994254319 June, 2014
Evonik Nutrition & Care GmbHDQS GmbHDarmstadt, Weiterstadt, GermanyGDP, GMP08 January, 202007 January, 2023527392 EXCI27 January, 2014
Ideal Cures Private LimitedSGSJammu, Jammu & Kashmir, IndiaGMP12 February, 202104 February, 2024IN/EXCiPACT/15/5005306 February, 2015
Ideal Cures Private LimitedSGSVasai (East), Palghar, IndiaGMP27. Apr 1826. Apr 21IN/EXCiPACT/15/5006027. Apr 15
JRS PharmaSGSCedar Rapids, Iowa, USAGMP27. Aug 1926. Aug 22US19/81994333127. Aug 19
JRS Pharma & Gujarat Microwax Private LimitedSGSNandasan, IndiaGMP19. Aug 1818. Aug 21IN18/50016519. Aug 18
JRS Pharma & Gujarat Microwax Private LimitedSGSNandasan, IndiaGMP19. Aug 1818. Aug 21IN18/500165.0119. Aug 19
JRS Pharma and Gujarat Microwax Pvt. Ltd. (Unit - IV)SGSMehsana, Gujarat, IndiaGMP17 December, 202017 December, 2023IN20/81884453617 December, 2020
JRS Pharma OyAJA (Global)Nastola, FinlandGMP27 January, 202027 January, 2023AJAEU/1585027 January, 2020
MEGGLE GmbH & Co. KgSGSWasserburg, GermanyGDP, GMP01 July, 202030 June, 2023DE17/81994308227 July, 2014
Merck KGaAblue inspection bodyDarmstadt, GermanyGDP, GMP17 June, 201917 June, 2022E-ME-18887-2019-0125 June, 2013
Merck Life Science Technologies (Nantong) Co., Ltd.Bureau Veritas ChinaNantong, Jiangsu, PR ChinaGMP30 June, 202029 June, 2023CNSH768274130 June, 2020
Microcellulose Weissenborn GmbH & Co KGDQS GmbHWeissenborn/Erzgebirge, GermanyGDP, GMP15 January, 201914 January, 2022537607 EXCI15 January, 2019
Nutrition & Biosciences USA 1 LLC Midland Ethocel OperationsSGSMidland, Michigan, USAGMP07 January, 201806 January, 2021US18/8182725807 January, 2018
Nutrition & Biosciences USA 1 LLC Midland Methocel OperationsSGSMidland, Michigan, USAGMP08 January, 201807 January, 2021US18/8182725708 January, 2018
Nutrition & Biosciences USA 1, LLC LA Methocel OperationsSGSPlaquemine, Louisiana, United StatesGMP26 June, 201825 June, 2021US18/8182745026 June, 2018
Omya SASBureau Veritas ChinaOrgon, FranceGMP23 January, 201922 January, 2022CNSH1034409601 January, 1970
Rettenmaier Iberica SL y Cia S.CAENORBarcelona, SpainGDP12 January, 202112 January, 2024EXC 2021/00112 January, 2021
Rettenmaier Natural Fiber Manufacturing (Changzhou) Co., Ltd.Bureau Veritas ChinaChangzou, PR ChinaGMP17 July, 202016 July, 2023CNSH686645917 July, 2020
ROQUETTE FRERESSGSLestrem, FranceGMP24 December, 201823 December, 2021FR15/8184199324 December, 2015
SEPPICSGSCastres, FranceGMP04. Sep 1803. Sep 21FR16/8184238722. Nov 13
SEPPIC (Shanghai) Chemical Specialities Co., LtdSGSShanghai, ChinaGMP24 July, 201923 July, 2022CN16/2169822. Nov 16
Specialty Products US, LLCSGSInstitute, West Virginia, USAGMP07 January, 201806 January, 2021US18/8182724507 January, 2018

Sources: Wikipedia, EXCiPACT, EXCiPACT 2