Reliable Intermediates Supplier

Good Manufacturing Practices - Quality Chemicals

Good Manufacturing Practices - Quality Chemicals

We can supply any of our products manufactured under GMP conditions.

These GMP products are usually used by pharmaceutical, biopharmaceutical and veterinary companies and can be used as:

Reagents
Starting material
Excipients
API

They are produced under the European GMP Guide for the manufacturing of drug products part II, active substances (ICH Q7).

We also offer multicompedial products: the product can be supplied in compliance with the quality standards of individual pharmacopoeias, a combination of several of them or even without a monograph in any pharmacopoeia.

Benefits of GMP Grade

With our GMP grade you get the following benefits:

Fast track to market, fast registration
High quality and safe raw materials; easier and safer to get process approval
Dossiers ready-to-use, no need to develop test methods or evaluate stability data
Compliance with international regulatory standards

Our GMP Grade Offerings

With the GMP grade we offer:

Strict working conditions following ICH guideline Q7-part II
Customised solutions and tailored packaging to meet your needs
Change control
Full traceability
Supplier audits
Dedicated regulatory support
Comprehensive dossiers in the international CTD format, acc. to ICH Module 3.

Please find more details about documents at “Supporting Documents” at Support in the Menu.

We have been regularly inspected by the Spanish Agency of Medicines and Medical Devices (AEMPS) since 2015, which means our quality assurance system is regularly monitored and audited by this authority.

Our quality system is also monitored by 30 audits per year by our pharma, cosmetics and food industry customers.

API

All our products manufactured suitable for use as APIs, are produced in GMP conditions and meet the requirements of the European GMP Guide for the manufacturing of drug products part II, active substances (ICH Q7).

For APIs we provide support to regulatory affairs:

CEP Certificate of Suitability of the European Pharmacopeia
ASMF Active Substance Master Files

All these documents can be provided in e-CTD format

APIs available:

Product	CAS No.	Code	EU ASMF	CEP	US DMF
Acetic Acid 80% w/w GMP	64-19-7	384110	Yes
Ammonium chloride GMP	12125-02-9	350314		R0-CEP 2021-326-Rev 00
Ammonium molybdate 4 hydrate GMP	12054-85-2	386915	Yes
Antimony potassium tartrate GMP	28300-74-5	388715	Yes
Calcium acetate anhydrous GMP	62-54-4	382110	Yes
Calcium hydrogenphosphate anhydrous GMP	7757-93-9	383410	Yes
Chromium (III) chloride 6-hydrate GMP	10125-13-0	388115	Yes
Zinc acetate 2-hydrate GMP	5970-45-6	351244		R0-CEP 2018-177-Rev 01
Zinc oxide GMP	1314-13-2	304814	Yes		Yes
Cobalt (II) chloride 6-hydrate GMP	7791-13-1	386010	Yes
Copper (II) Chloride 2-hydrate GMP	10125-13-0	387843	Yes
Copper (II) oxide GMP	1317-38-0	352702	Yes
Copper II sulphate 5-hydrate GMP	7758-99-8	380214	Yes
Copper(II) hydroxicarbonate(Malaquita) GMP	12069-69-1	353510	Yes		Yes
Di-sodium hydrogenphosphate 12-hydrate GMP	10039-32-4	351544		CEP 2017-233-Rev 02
EDTA, iron (III) sodium salt 3-hydrate	18154-32-0	333310	Yes
Iron (III) chloride sol. 10-14% GMP	7705-08-0	382337	Yes
L(+)-Tartaric acid GMP	87-69-4	381414	Yes
Magnesium acetate 4-hydrate (parenteral) GMP	16674-78-5	353042		R0-CEP 2017-280-Rev 01
Magnesium bromide 6-hydrate GMP	16674-78-5	385610	Yes
Magnesium fluoride GMP	16674-78-5	355510	Yes
Magnesium hydroxide GMP	1309-42-8	384514	Yes
Magnesium L-lactate 2-hydrate GMP	18917-93-6	353414	Yes
Manganese carbonate precipitated GMP	598-62-9	352310	Yes		Yes
Manganese (II) chloride 4-hydrate GMP	13446-34-9	354115	Yes
Nickel sulfate 6-hydrate GMP	10101-97-0	387543	Yes
Phenol GMP	108-95-2	352610	Yes
Potassium acetate GMP	127-08-2	387144		CEP 2018-028-Rev 01
Potassium bromide GMP	7758-02-3	351814	Yes
Potassium bromide GMP Crystal.	7758-02-3	371414	Yes
Potassium chlorate GMP	3811-04-9	384610	Yes
Potassium iodate GMP	7758-05-6	386811	Yes
Sodium acetate 3-hydrate GMP	6131-90-4	350944		CEP 2018-100-Rev 01
Sodium dihydrogen phosphate anhydrous GMP	7558-80-7	382015	Yes
Sodium dihydrogenphosphate 1-hydrate GMP	10049-21-5	351015	Yes
Sodium dihydrogenphosphAte 2-hydrate GMP	10028-24-7	351142		CEP 2017-177-Rev 02
Sodium fluoride GMP	7681-49-4	353314		CEP R1-CEP 2016-103-Rev 00
Sodium molybdate 2-hydrate GMP	10102-40-6	387614	Yes
Sodium molybdate 2-hydrate GMP	10102-40-6	387610	Yes
Sodium selenite GMP	10102-18-8	352514	Yes		Yes
Succinic acid GMP	110-15-6	382216	Yes
Tri-sodium citrate 2-hydrate GMP	6132- 04- 3	383215			Yes
Urea GMP	57-13-6	381114	Yes
Sodium Thiosulfate 5-hydrate PH	7772-98-7	380814		CEP 2024-569 - Rev 00
Zinc Acetate 2-Dihydrat PH	5970-45-6	351244		CEP 2018-177 - Rev 02

Excipients

All our products suitable for use as excipients are produced in GMP conditions and meet the requirements for excipients according to the joint IPEC-PQG