Certificates

This section of the website lists the status of all EXCiPACT™ Certificates issued by our approved Certification Bodies. It is intended to be a reliable source of information about EXCiPACT™  – approved suppliers for those who use pharmaceutical excipients.

EXCiPACT™ Certificates can only be issued by those Certification Bodies who have been audited and registered as approved by EXCiPACT and have fully implemented the Scheme rules into their management systems and whose auditors have undergone a rigorous assessment process in order to be EXCiPACT™ registered. Such auditors will have completed both the formal EXCiPACT Training Programme and have been witnessed to verify that the standards and the auditor training had been defined and implemented correctly.

If an organisation is not listed and who claims to have EXCiPACT™ Certification then it may not have been audited by a Registered Certification Body and/or using a Registered EXCiPACT™ Auditor and or adhered to the other rules governing the issue of EXCiPACT™ Certificates. In any question of doubt, please contact info@excipact.org.  A listing is made only when certification fees have been paid to EXCiPACT asbl by the Registered Certification Body.

 

A & C American Chemicals Ltd.

Certifying Body: SGS, FR
Site Location: Quebec, CA
Scope: GDP, GMP

Manufacture, testing, storage and shipment of Pharmaceutical Excipients.

Status: valid
Issue Date: 13 December, 2013
Expiry Date: 12 December, 2016
Reg Number: FR14/018443

Ashland Aquarius™ Plant

Certifying Body: SGS, BE
Site Location: Wilmington, Delaware, USA
Scope: GMP

Manufacturing, testing, and packaging of pharmaceutical excipients used as film coatings in pharmaceutical industry. Relevant products are of brand Aquarius™.

Status: valid
Issue Date: 5 April, 2016
Expiry Date: 4 April, 2019
Reg Number: CH16/0163

Ashland Speciality Ingredients (ASI)

Certifying Body: SGS, FR
Site Location: Texas City, USA
Scope: GMP

Good Manufacturing Practices for the following activities
Manufacturing, testing and packaging of Povidone, Copovidone, Crospovidone, and Pharmasolve used as pharmaceutical excipients

Status: valid
Issue Date: 24 December, 2015
Expiry Date: 23 December, 2018

Ashland Speciality Ingredients ISP Chemicals LLC

Certifying Body: SGS, BE
Site Location: Calvert City, USA
Scope: GMP

Manufacturing, testing and packaging of polyvinylpyrrolidone (PVP) and polyvinylpolypyrrolidone (PVPP) used as pharmaceutical excipients.

Status: valid
Issue Date: 29 April, 2015
Expiry Date: 28 April, 2018
Reg Number: CH15/1338

Aug. Hedinger Gmbh & Co. KG Stuttgart, DE

Certifying Body: mdc, DE
Site Location: Stuttgart, Teutschenthal, DE
Scope: GDP, GMP

Manufacturing of Excipients (e.g. Glycerol 85%, acetic acid 80%, purified water, aqueos solutions).

Re-packaging of Excipients (e.g. Isopropanol, Acetone, Glycerol, Propyleneglycol, acetic acid, metacresol, solids).

Analytical testing and release of Excipients according to pharmacopoeia requirements and 2001/83/EC.

Warehousing and shipment of Excipients (Distribution).

Status: valid
Reg Number: 2675.75.01/0

BASF, DE

Certifying Body: mdc, DE
Site Location: Ludwigshafen, DE
Scope: GDP, GMP

Manufacturing, testing, packaging, storage and release of pharmaceutical excipients of group of polyvinylpyrrolidone (Kollidon®) polymers (Homo and Co-Polymers of different molecular weight ranges, crosslinked or linear type materials).

Status: valid
Issue Date: 25 June, 2013
Expiry Date: 25 June, 2016
Reg Number: D1369200001

BIOGRUND GmbH

Certifying Body: DQS GmbH, DE
Site Location: Hünstetten, DE
Scope: GMP

Manufacture of Ready-to-use-Excipients Preparations for Solid Dosage Forms (for product groups 1-6 see below)

Scope 1: Ready-to-use film coating agents (AquaPolish® brand group, BonuLac®, NutraPolish) as excipients for the production of Solid Dosage Forms.

Scope 2: Ready-to-use tabletting agents (CompactCel® brand group, RetardCel®, BonuMill) as excipients for the production of Solid Dosage Forms.

Scope 3: Ready-to-use coloring agents (TopMill® brand group, BonuTone®, BonuPrint).

Scope 4: Ready-to-use sugar coating agents (IsuPolish® brand group).

Scope 5: Ready-to-use polishing agents (Bonuwax brand group).

Scope 6: Ready-to-use film coating agents (Eudragit® EPO ReadyMix brand group) as excipients for the production of Solid Dosage Forms.

Status: valid
Issue Date: 26 August, 2013
Expiry Date: 25 August, 2016
Reg Number: 296948 EXCI

Ba'Emek Advanced Technologies LTD

Certifying Body: AJA
Site Location: Afula
Scope: GMP

Manufacture of Pharma grade lactose production & storage

Status: valid
Issue Date: 11 April, 2016
Expiry Date: 11 April, 2016
Reg Number: Israel

Boai NKY Pharmaceuticals Ltd.

Certifying Body: BV China, PRC
Site Location: Jiaozuo, Henan Province, PR China
Scope: GMP

Manufacture of Povidone (KoVidone®), Crospovidone(PolyKoVidone®), Copovidone (KoVidone® VA64) used in pharmaceuticals as an excipient

Status: valid
Issue Date: 27 April, 2015
Expiry Date: 26 April, 2018
Reg Number: CNBJ510001-EP

Capsugel Belgium bvba

Certifying Body: SGS, FR
Site Location: Bornem, BE
Scope: GMP

The manufacturing of printed and non-printed gelatin capsules for pharmaceutical use.

Status: valid
Issue Date: 27 July, 2014
Expiry Date: 30 June, 2017
Reg Number: FR14/18889

Capsugel France SAS

Certifying Body: SGS, FR
Site Location: Colmar, FR
Scope: GMP

The manufacturing of Gelatin and HPMC printed and unprinted empty capsules for pharmaceutical use.

Status: valid
Issue Date: 14 July, 2014
Expiry Date: 30 July, 2017
Reg Number: FR14/18975

Carbagas AG

Certifying Body: AJA
Site Location: Utzenstorf, CH
Scope: GDP, GMP

Manufacture and distribution of pharmaceutical grade cryogenic liquefied gases (nitrogen, oxygen, argon)

 

Status: valid
Issue Date: 15 December, 2015
Expiry Date: 15 December, 2018
Reg Number: AJAGER/16/001

Chemische Fabrik Budenheim KG

Certifying Body: SGS, FR
Site Location: Budenheim, DE
Scope: GDP, GMP

Manufacture, testing, storage and distribution of sodium, magnesium & calcium phosphates excipients used as pharmaceutical excipient or claimed for pharmaceutical use.

Status: valid
Issue Date: 6 February, 2014
Expiry Date: 4 February, 2017
Reg Number: FR14/018789

Colorcon Asia Private Limited

Certifying Body: SGS, BE
Site Location: Verna, Goa, India
Scope: GMP

Manufacture and supply of pharmaceutical excipients:

  • Formulated powder (dry dispersion) comprising of Polymers;
  • Plasticizers and pigments & color; and
  • Formulated blends of pigments and iron oxide.
Status: valid
Issue Date: 29 March, 2016
Expiry Date: 28 March, 2019
Reg Number: IN/EXP/16/50074

Colorcon Ltd

Certifying Body: SGS, FR
Site Location: Dartford, UK
Scope: GDP, GMP

The manufacture of formulated powder and liquid dispersions comprising of polymers, plasticisers and pigments and other formulated excipient blends. The supply of pharmaceutical excipients for the manufacture of dosage forms of medicinal products.

Status: valid
Issue Date: 6 February, 2015
Expiry Date: 5 February, 2018
Reg Number: GB15/93006

Croda Chocques SAS

Certifying Body: SGS, FR
Site Location: Chocques, FR
Scope: GMP

Manufacture and distribution of ethylene oxide and propylene oxide derivatives as excipients for pharmaceuticals

Status: valid
Issue Date: 10 September, 2015
Expiry Date: 9 September, 2018
Reg Number: FR15/81841880

Croda Europe Ltd

Certifying Body: SGS, FR
Site Location: Goole, Thorne, GB
Scope: GDP, GMP

Design, development, manufacturing, supply, testing, and distribution of pharmaceutical excipients or chemicals claimed for pharmaceutical use.

Manufacturing site: Croda Europe Ltd., Rawcliffe Bridge, Goole, DN14 8PN, UK.

Manufacturing processes include: alkoxylation, blending, chlorination, phosphation, polymerisation, separation, purification, esterification, and final filling & packaging. Products are naturally based speciality chemicals including, amongst others: lanolin and derivatives, non-ionic surfactants, emollient esters and ethers, sorbitan esters, fatty acid chlorides and their derivatives, functional blends thereof, acrylic liquid dispersions and solution polymers.

Distribution site: Thorne Distribution Center, Unit 6, Alpha Court, Thorne, DN8 5TZ, UK

Processes include: receipt and verification of purchased material and products from above mentioned manufacturing site, the storage and distribution of these materials and products.

Status: valid
Issue Date: 27 January, 2014
Expiry Date: 26 January, 2017
Reg Number: FR14/018521

Croda Iberica SA

Certifying Body: SGS, FR
Site Location: Mevisa, Barcelona, ES
Scope: GDP, GMP

Design, development, manufacturing, supply, testing and distribution of pharmaceutical excipients. Manufacturing processes include esterification, alcoxylation, and blending of derivatives thereof.

Distribution includes warehousing and distribution of pharmaceutical excipients manufactured at site and at other sites within the Croda group.

Products are naturally based specialty chemicals including, amongst others: non-ionic surfactants, fatty acid esters, sorbitan esters and functional blends thereof.

Status: valid
Issue Date: 25 July, 2014
Expiry Date: 24 July, 2017
Reg Number: FR14/018849

Croda Singapore Pte Ltd

Certifying Body: SGS, BE
Site Location: Singapore
Scope: GDP, GMP

Manufacturing and distribution of Excipients like Polysorbates, Sorbitan esters, medium chain triglycerides, mono and diglycerides, Propylene Glycol, Dicaprylate/Dicaprate, Cetyl Palmitate, Diethylene, Glycol Palmitostearate, Macrogol Stearate, Macrogol Stearyl Ether,
Macrogol Glycerol, Cocoates/Caprylocaprate

 

Status: valid
Issue Date: 15 February, 2016
Expiry Date: 14 February, 2019
Reg Number: Certificate SG16/80983

Evonik Industries AG

Certifying Body: mdc, DE
Site Location: Darmstadt, DE
Scope: GMP

Manufacturing, testing, packaging, storage and release of Acrylate/Methacrylate-copolymers (trade name: EUDRAGIT®) used as functional excipients for controlled release of active pharmaceutical ingredients for oral and dermal dosage forms.

Status: valid
Issue Date: 10 December, 2015
Expiry Date: 8 December, 2016
Reg Number: D1372800001

Grace GmbH & Co. KG

Certifying Body: DQS GmbH, DE
Site Location: Worms, DE
Scope: GMP

Manufacture of amorphous silica gel used in pharmaceuticals as an excipient.

Status: valid
Issue Date: 30 April, 2015
Expiry Date: 30 April, 2018
Reg Number: 415602 EXCI

Ideal Cures Private Ltd (IN)

Certifying Body: SGS, FR
Site Location: Jammu, IN
Scope: GMP

Manufacture of Film-Coating Materials and & Specialty Products (Neutral Pellets & Eco-cool Extended cooling Booster for use as Excipients in Pharmaceutical Applications. Eco-cool Extended cooling Booster for use as Excipients in Pharmaceutical Applications.

Status: valid
Issue Date: 24 September, 2014
Expiry Date: 23 September, 2017
Reg Number: IN/EXCiPACT/15/50053

Ideal Cures Private Ltd

Certifying Body: SGS, FR
Site Location: Khambhat, IN
Scope: GMP

Manufacture of Methacrylic acid co-polymers & dispersions and Ethyl Acrylate co-polymers as Excipients for Pharmaceutical applications.

Status: valid
Issue Date: 6 February, 2015
Expiry Date: 5 February, 2018
Reg Number: IN/EXCiPACT/15/50054

Ideal Cures Private Ltd

Certifying Body: SGS, FR
Site Location: Thane, IN
Scope: GMP

Manufacture of Film-Coating Materials and Eco-cool Extended cooling Booster for use as Excipients in Pharmaceutical Applications.

Status: valid
Issue Date: 27 February, 2015
Expiry Date: 26 February, 2018
Reg Number: IN/EXCiPACT/15/50060

Lanolines Stella sa

Certifying Body: SGS, FR
Site Location: Moucron, BE
Scope: GMP

Manufacture of pharmaceutical grade lanolin, lanolin oil and lanolin wax.

Status: valid
Issue Date: 1 July, 2014
Expiry Date: 30 June, 2017
Reg Number: FR14/18921

Merck KGaA Darmstadt, DE

Certifying Body: mdc, DE
Site Location: Darmstadt, DE
Scope: GDP, GMP

Sourcing, manufacturing, testing, packaging, storage, release for product of “EMPROVE® exp” and “EMPROVE® bio” lines such as organic and inorganic salts, organic and inorganic acids and bases, solvent and aqueous solutions.

Status: valid
Issue Date: 25 June, 2013
Expiry Date: 25 June, 2016
Reg Number: 2677.77.01/0

Molkerei Meggle GmbH

Certifying Body: SGS, FR
Site Location: Wasserburg, DE
Scope: GDP, GMP

Manufacture, testing, storage and distribution of lactose and co-processed excipients used as pharmaceutical excipient or claimed for pharmaceutical use.

Status: valid
Issue Date: 19 June, 2014
Expiry Date: 13 April, 2017
Reg Number: FR14/18882

NOVACARB France

Certifying Body: SGS, FR
Site Location: Laneuveville-devant-Nancy, FR
Scope: GMP

Manufacturing, Packaging and Distribution of sodium bicarbonate HD110 in Big Bags.

Status: valid
Issue Date: 10 September, 2015
Expiry Date: 9 September, 2018
Reg Number: FR15/81841714

ROQUETTE FRERES

Certifying Body: SGS, FR
Site Location: Lestrem, FR
Scope: GMP

Design, production and storage of excipients made from amylaceous substances:

  • Native starches – (maize and wheat // B grade)
  • Pregelatinised starches – (product line LYCATAB®)
  • Modified starches – (product line GLYCOLYS®)
  • Monohydrate & anhydrous Glucoses
  • Sorbitol powders – (product line NEOSORB® P 70/xx and POLYSORB® 85/70/00)
  • Maltitol powders (product line SWEETPEARL®)
  • Maltitol solutions (LYCASIN®  80/55, LYCASIN® 75/75 and POLYSORB® 75/55)
  • Mannitol powders (product line PEARLITOL®) and PEARLITOL FLASH®
  • Xylitol powders (product line XYLISORB®)
Status: valid
Issue Date: 11 November, 2015
Expiry Date: 10 November, 2018
Reg Number: FR15/81841993

SEPIPROD (production site of SEPPIC)

Certifying Body: mdc, DE
Site Location: Castres, FR
Scope: GMP

Manufacturing, testing, packaging, storage and release of pharmaceutical starting materials (Excipients) i.e. SEPIFILM™, SEPICOAT™, SEPISPERSE™, SEPISTAB™, SEPITRAP™, SEPINEO™, MONTANETM and MONTANOX™ PREMIUM range (Pharmaceutical-range of emulsifiers.

Status: valid
Issue Date: 4 October, 2013
Expiry Date: 3 October, 2016
Reg Number: D137140002

Saudi Kayan Petrochemical Company (SABIC affiliate) 

Certifying Body: SGS, FR
Site Location: Jubail, SA
Scope: GDP, GMP

Manufacture and distribution of Petrolatum (petroleum jelly), White Oils and microcrystalline waxes as pharmaceutical excipients and chemicals claimed for pharmaceutical use.

Status: valid
Issue Date: 19 November, 2013
Expiry Date: 17 October, 2016
Reg Number: FR13/018279

Sonneborn refined products BV

Certifying Body: SGS, FR
Site Location: Amsterdam, NL
Scope: GDP, GMP

Manufacture and distribution of Petrolatum (petroleum jelly), White Oils and microcrystalline waxes as pharmaceutical excipients and chemicals claimed for pharmaceutical use.

Status: valid
Issue Date: 22 November, 2013
Expiry Date: 21 November, 2016
Reg Number: FR13/018373

Vikram Thermo (India) Ltd

Certifying Body: SGS, FR
Site Location: Gujarat, IN
Scope: GMP

Manufacturing, Testing, Packaging, Storage and Release of Acrylate/Methacrylate Co-polymers used as functional excipients in pharmaceuticals.

Status: valid
Issue Date: 16 April, 2015
Expiry Date: 15 April, 2018
Reg Number: IN/EXCiPACT/15/50052