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 email@example.com. A listing is made only when certification fees have been paid to EXCiPACT asbl by the Registered Certification Body.
A & C American Chemicals Ltd.
Ashland Aquarius™ Plant
Manufacturing, testing, and packaging of pharmaceutical excipients used as film coatings in pharmaceutical industry. Relevant products are of brand Aquarius™.
Ashland Speciality Ingredients (ASI)
Manufacturing, testing and packaging of Povidone, Copovidone, Crospovidone, and Pharmasolve used as pharmaceutical excipients
Ashland Speciality Ingredients ISP Chemicals LLC
Manufacturing, testing and packaging of polyvinylpyrrolidone (PVP) and polyvinylpolypyrrolidone (PVPP) used as pharmaceutical excipients:
- Lower molecular weight PVPs: Plasdone™ K29/32, PVP K30PI
- Higher molecular weight PVPs: Plasdone™ K90, Plasdone™ K90D
- Polyplasdone™ (PVPP): Polyplasdone™ XL, Polyplasdone™ XL-10, Polyplasdone™ INF-10
Aug. Hedinger Gmbh & Co. KG Germany
Manufacturing of Excipients (e.g. Glycerol 85%, acetic acid 80%, purified water, aqueos solutions).
Re-packaging of Excipients (e.g. Isopropanol, Acetone, Glycerol, Propylene glycol, acetic acid, metacresol, solids), analytical testing and release of excipients according to pharmacopoeia requirements and 2001/83/EC, warehousing and shipment of Excipients (Distribution).
Ba'Emek Advanced Technologies LTD
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).
BCN Trasvases, S.L.
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® E PO ReadyMix brand group) as excipients for the production of Solid Dosage Forms.
Scope 7: Re-packaging and Re-labelling of pharmaceutical Excipients (Bonucel® brand group) under GMP Conditions
Boai NKY Pharmaceuticals Ltd.
Manufacture of Povidone (KoVidone®), Crospovidone(PolyKoVidone®), Copovidone (KoVidone® VA64) used in pharmaceuticals as an excipient
Capsugel Belgium bvba
Capsugel France SAS
The manufacturing of Gelatin and HPMC printed and unprinted empty capsules for pharmaceutical use.
Manufacture and distribution of pharmaceutical grade cryogenic liquefied gases (nitrogen, oxygen, argon)
Chemische Fabrik Budenheim KG
Manufacture, testing, storage and distribution of sodium, magnesium & calcium phosphates used as pharmaceutical excipient or claimed for pharmaceutical use.
Colorcon Asia Private Limited
Manufacture and supply of pharmaceutical excipients:
- Formulated powder (dry dispersion) comprising of Polymers;
- Plasticizers and pigments & color;
- Formulated blends of pigments and iron oxide.
The manufacture of formulated powder and liquid dispersions, comprising of polymers, plasticisers and pigments and other formulated pharmaceutical excipient blends. The supply of pharmaceutical excipients for the manufacture of dosage forms of medicinal products.
Croda Chocques SAS
Manufacture and distribution of ethylene oxide and propylene oxide derivatives as excipients for pharmaceuticals
Croda Europe Ltd
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.
Croda Iberica SA
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 on 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.
Croda Singapore Pte Ltd
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
Evonik Industries AG
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.
Grace GmbH & Co. KG
Manufacture of synthetic amorphous silica gel used in pharmaceuticals as an excipient.
Ideal Cures Private Ltd
Manufacture of Methacrylic acid co-polymers & dispersions and Ethyl Acrylate co-polymers as Excipients for Pharmaceutical applications.
Ideal Cures Private Ltd
Manufacture of Film Coating Materials and & Specialty Products (Neutral Pellets & Eco-cool Extended cooling Booster) for use as Excipients in Pharmaceutical Applications.
Ideal Cures Private Ltd
Manufacture of Film Coating Materials and Eco-cool Extended cooling Booster for use as Excipients in Pharmaceutical Applications.
Lanolines Stella sa
Manufacture of pharmaceutical grade lanolin, lanolin oil and lanolin wax.
Merck KGaA Darmstadt, DE
Sourcing, manufacturing, testing, packaging, storage, release for product of “EMPROVE®exp”, “EMPROVE®bio”, “EMPROVE®ESSENTIAL” and “EMPROVE®EXPERT” lines such as organic and inorganic salts, organic and inorganic acids and bases, solvent and aqueous solutions.
Molkerei MEGGLE Wasserburg GmbH & Co. KG.
Manufacture, testing, storage and distribution of lactose and co-processed excipients used as pharmaceutical excipient or claimed for pharmaceutical use.
Nanjing Duoyuan Biochemistry Co., Ltd.
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 and XTAB xx)
- Sorbitol solutions – (product line NEOSORB® 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®)
Saudi Kayan Petrochemical Company (A SABIC affiliate)
Manufacturing, storage and supply of Ethanolamine and Ethoxylate as an Excipient for Pharmaceutical Finished Products.
SEPIPROD (production site of SEPPIC)
Manufacturing, testing, packaging, storage and release of pharmaceutical starting materials (Excipients) i.e. SEPIFILM™, SEPICOAT™, SEPISPERSE™, SEPISTAB™, SEPITRAP™, SEPINEO™, MONTANE™ and MONTANOX™ PREMIUM range (Pharmaceutical-range of emulsifiers).
Sonneborn refined products BV
Manufacture and distribution of Petrolatum (petroleum jelly), White Oils and microcrystalline waxes as pharmaceutical excipients and chemicals claimed for pharmaceutical use.
Vikram Thermo (India) Ltd
Manufacturing, Testing, Packaging, Storage and Release of Acrylate/Methacrylate Co-polymers used as functional excipients in pharmaceuticals.