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.

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

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.

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:

ProductCAS No.CodeEU ASMFCEPUS DMF
Acetic Acid 80% w/w GMP64-19-7384110
Ammonium chloride GMP12125-02-9350314R0-CEP
Ammonium molybdate 4 hydrate GMP12054-85-2

386915
Calcium hydrogenphosphate anhydrous GMP7757-93-9383410
Chromium (III) chloride 6-hydrate GMP USP10125-13-0388815
Cinc acetate 2-hydrate (parenteral) GMP5970-45-6351244R0-CEP 2018-117-Rev 00
Cinc oxide GMP1314-13-2304814
Cobalt (II) chloride 6-hydrate GMP QP7791-13-1386010
Copper (II) oxide GMP1317-38-0352702
Copper (II) sulfate anhydrous GMP7758-98-7382914
Copper II sulphate 5-hydrate GMP7758-99-8380214
Copper(II) hydroxicarbonate(Malaquita) GMP12069-69-1353510
Di-sodium hydrogenphosphate 12-hydrate (parenteral) GMP10039-32-4351544R0-CEP 2017-233-Rev 00
L(+)-Tartaric acid GMP87-69-4381414
Magnesium acetate 4-hydrate (parenteral) GMP16674-78-5353042R0-CEP 2017-280-Rev 00
Magnesium bromide 6-hydrate GMP QP16674-78-5385610
Magnesium fluoride GMP QP16674-78-5355510
Magnesium hydroxide GMP1309-42-8384514
Magnesium L-lactate 2-hydrate GMP18917-93-6353414
Manganese carbonate precipitated GMP598-62-9352310
Phenol GMP108-95-2352610
Potassium acetate (parenteral) GMP127-08-2387144R0-CEP 2018-028-Rev 00
Potassium bromide GMP7758-02-3351814
Potassium chlorate GMP3811-04-9384610
Potassium iodate GMP7758-05-6386811
Sodium acetate 3-hydrate (parenteral) GMP6131-90-4350944R0-CEP 2018-100-Rev 00
Sodium dihydrogen phosphate anhydrous GMP USP7558-80-7382015
Sodium dihydrogenphosphate 1-hydrate GMP10049-21-5351015
Sodium dihydrogenphosphate 2-hydrate (parenteral) GMP10028-24-7351142R0-CEP 2017-177-Rev 00
Sodium fluoride GMP PH7681-49-4353314R0-CEP 2016-103-Rev 01
Sodium molybdate 2-hydrate GMP PH10102-40-6387614
Sodium molybdate 2-hydrate GMP QP10102-40-6387610
Sodium selenite GMP PH10102-18-8352514
Succinic acid110-15-6382216
Tri-sodium citrate 2-hydrate GMP6132- 04- 3383243
Urea GMP57-13-6381114

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 GMP Guide for pharmaceutical excipients.

We provide all documentation needed for excipients on request.

Product range available:

CODEPRODUCTCAS NUMBER
385910ACETIC ACID 33% w/w GMP QP64-19-7
384110ACETIC ACID 80% w/w GMP QP64-19-7
350214ALUMINIUM POTASSIUM SULPHATE 12-HYDRATE GMP PH7784-24-9
308210AMINOACETIC ACID (GLYCINE) gmp QP56-40-6
305314BENZOIC ACID gmp PH65-85-0
383410CALCIUM HYDROGEN PHOSPHATE ANHYDROUS GMP QP7757-93-9
388115CHROMIUM (III) CHLORIDE 6-HYDRATE GMP USP10060-12-5
388143CHROMIUM (III) CHLORIDE 6-HYDRATE GMP USP PARENTERAL USE10060-12-5
305210CITRIC ACID 1-HYDRATE gmp QP5949-29-1
353510COPPER (II) CARBONATE, BASIC (MALACHITE)GMP QP12069-69-1
387815COPPER (II) CHLORIDE 2-HYDRATE GMP USP10125-13-0
387843COPPER (II) CHLORIDE 2-HYDRATE GMP USP PARENTERAL USE10125-13-0
352702COPPER (II) OXIDE GMP PE1317-38-0
380214COPPER (II) SULPHATE 5-HYDRATE GMP PH7758-99-8
380215COPPER (II) SULPHATE 5-HYDRATE GMP USP7758-99-8
382914COPPER (II) SULPHATE ANHYDROUS GMP PH7758-98-7
351544di-SODIUM HYDROGEN PHOSPHATE 12-HYDRATE GMP PH PARENTERAL USE10039-32-4
385310di-SODIUM HYDROGEN PHOSPHATE 2-HYDRATE GMP QP10028-24-7
383525di-SODIUM HYDROGEN PHOSPHATE ANHYDROUS GMP PAB7558-79-4
383502di-SODIUM HYDROGEN PHOSPHATE ANHYDROUS GMP PE7558-79-4
383510di-SODIUM HYDROGEN PHOSPHATE ANHYDROUS GMP QP7558-79-4
387744EDTA, ACID GMP PH PARENTERAL USE60-00-4
387742EDTA, ACID GMP QP PARENTERAL USE60-00-4
351414EDTA, DISODIUM SALT 2-HYDRATE GMP PH6381-92-6
351410EDTA, DISODIUM SALT 2-HYDRATE GMP QP6381-92-6
306110FUMARIC ACID gmp QP110-17-8
350014IRON (II) CHLORIDE 4-HYDRATE GMP PH13478-10-9
382360IRON (III) CHLORIDE SOL. 10-14% Fe w/w GMP PA7705-08-0
382302IRON (III) CHLORIDE SOL. 10-14% Fe w/w GMP PE7705-08-0
382337IRON (III) CHLORIDE SOL. 10-14% Fe w/w GMP QP MICROBIOLOGICALLY TESTED7705-08-0
382305IRON (III) CHLORIDE SOL. 10-14% Fe w/w GMP RE7705-08-0
352914iso-PROPYL ALCOHOL GMP PH67-63-0
352910iso-PROPYL ALCOHOL GMP QP67-63-0
381414L(+)-TARTARIC ACID GMP PH87-69-4
381410L(+)-TARTARIC ACID GMP QP87-69-4
353042MAGNESIUM ACETATE 4-HYDRATE GMP QP PARENTERAL USE16674-78-5
385610MAGNESIUM BROMIDE 6-HYDRATE GMP QP13446-53-2
355510MAGNESIUM FLUORIDE GMP QP7783-40-6
384514MAGNESIUM HYDROXIDE GMP PH1309-42-8
353414MAGNESIUM L-LACTATE 2-HYDRATE GMP PH18917-93-6
352310MANGANESE CARBONATE PRECIPITATED GMP QP598-62-9
354142MANGANESE (II) CHLORIDE 4-HYDRATE GMP QP PARENTERAL USE13446-34-9
352610PHENOL GMP QP108-95-2
387144POTASSIUM ACETATE GMP PH PARENTERAL USE127-08-2
351814POTASSIUM BROMIDE GMP PH7758-02-3
386402POTASSIUM CARBONATE ANHYDROUS, GRANULATED GMP PE584-08-7
384610POTASSIUM CHLORATE GMP QP3811-04-9
386514POTASSIUM HYDROGEN CARBONATE GMP PH298-14-6
386510POTASSIUM HYDROGEN CARBONATE GMP QP298-14-6
350110POTASSIUM NITRATE GMP QP7757-79-1
350944SODIUM ACETATE 3-HYDRATE GMP PH PARENTERAL USE6131-90-4
306002SODIUM CHLORIDE gmp PE7647-14-5
306014SODIUM CHLORIDE gmp PH7647-14-5
306010SODIUM CHLORIDE gmp QP7647-14-5
351015SODIUM DIHYDROGEN PHOSPHATE 1-HYDRATE GMP USP10049-21-5
351114SODIUM DIHYDROGEN PHOSPHATE 2-HYDRATE GMP PH13472-35-0
351142SODIUM DIHYDROGEN PHOSPHATE 2-HYDRATE GMP QP PARENTERAL USE13472-35-0
382015SODIUM DIHYDROGEN PHOSPHATE ANHYDROUS GMP USP7558-80-7
353314SODIUM FLUORIDE GMP PH7681-49-4
353310SODIUM FLUORIDE GMP QP7681-49-4
386130SODIUM HYDROXIDE 0.1M GMP DV1310-73-2
386230SODIUM HYDROXIDE 0.5M GMP DV1310-73-2
386330SODIUM HYDROXIDE 0.5M/SODIUM CHLORIDE 0.5M GMP DV.
384930SODIUM HYDROXIDE 2M/SODIUM CHLORIDE 2M GMP DV.
384830SODIUM HYDROXIDE 3M GMP DV1310-73-2
301314SODIUM HYDROXIDE, PELLETS gmp PH1310-73-2
301310SODIUM HYDROXIDE, PELLETS gmp QP1310-73-2
384050SODIUM HYDROXIDE SOL.32% w/w GMP DE1310-73-2
384002SODIUM HYDROXIDE SOL.32% w/w GMP PE1310-73-2
384007SODIUM HYDROXIDE SOL.32% w/w GMP PRS1310-73-2
387614SODIUM MOLYBDATE 2-HYDRATE GMP PH10102-40-6
387610SODIUM MOLYBDATE 2-HYDRATE GMP QP10102-40-6
352502SODIUM SELENITE GMP PE10102-18-8
352514SODIUM SELENITE GMP PH10102-18-8
352544SODIUM SELENITE GMP PH PARENTERAL USE10102-18-8
352507SODIUM SELENITE GMP PRS10102-18-8
352510SODIUM SELENITE GMP QP10102-18-8
385110SODIUM SUCCINATE 6-HYDRATE GMP QP6106-21-4
380714SODIUM SULPHATE 10-HYDRATE GMP PH7727-73-3
380710SODIUM SULPHATE 10-HYDRATE GMP QP7727-73-3
380502SODIUM SULPHATE ANHYDROUS GMP PE7757-82-6
380514SODIUM SULPHATE ANHYDROUS GMP PH7757-82-6
380814SODIUM THIOSULPHATE 5-HYDRATE GMP PH10102-17-7
380810SODIUM THIOSULPHATE 5-HYDRATE GMP QP10102-17-7
382216SUCCINIC ACID GMP NF110-15-6
381210TIN (II) CHLORIDE 2-HYDRATE GMP QP10025-69-1
383243tri-SODIUM CITRATE 2-HYDRATE GMP USP PARENTERAL USE6132-04-3
381114UREA GMP PH57-13-6
351214ZINC ACETATE 2-HYDRATE GMP PH5970-45-6
351244ZINC ACETATE 2-HYDRATE GMP PH PARENTERAL USE5970-45-6
304814ZINC OXIDE gmp PH1314-13-2
353115ZINC SULPHATE 1-HYDRATE GMP USP7446-19-7
351314ZINC SULPHATE 7-HYDRATE GMP PH7446-20-0
351310ZINC SULPHATE 7-HYDRATE GMP QP7446-20-0
351343ZINC SULPHATE 7-HYDRATE GMP USP PARENTERAL USE7446-20-0

A special grade of water has to be used when manufacturing APIs and excipients intended to be used in sterile, parenteral drug products. We manufacture “Parenteral grade” products using purified water with an endotoxins limit lower than 0.25 EU/ml and a total aerobic count limit lower than 100 cfu/ml.

Most of the time mineral salts for injectable use need to have low endotoxin content. Pharmacopoeias would indicate the maximum level of endotoxins allowed depending on the product. In other cases the level of endotoxins is specified by our customers.

High-purity salts for parenteral use are manufactured in our GMP plant in Venta de Baños under strict GMP, ICH Q7 compliant conditions.

These salts can be used in parenteral products:

  • Solutions and powders for injection
  • Solutions for dialysis
  • Solutions for infusion

We offer the following products. However, we can produce any of our salts in low-endotoxin grade on demand.

CODEPRODUCTCAS Number
3400di-sodium hydrogen phosphate 12-H2O parenteral GMP
10039-32-4
3403EDTA, disodium salt 2 hydrate parenteral GMP6381-92-6
3407Magnesium acetate 4 hydrate parenteral use GMP16674-78-5
3405Potassium acetate parenteral use GMP
127-08-2
3406Potassium bromide parenteral use GMP7758-02-3
3402Potassium dihidrogen phosphate parenteral use GMP
7778-77-0
3404Sodium acetate 3 hydrate parenteral use GMP6131-90-4
3401Sodium dihydrogen phosphate 2 H2O parenteral GMP
13472-35-0
3413tri-Sodium citrate 2 hydrate parenteral use GMP6132-04-3
3414Zinc acetate 2 hydrate parenteral use GMP
5970-45-6