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 GMP

64-19-7

384110

Ammonium chloride GMP

12125-02-9

350314RO-CEP-2021-326-Rev 00

Ammonium molybdate 4 hydrate GMP

12054-85-2

386915

Antimony potassium tartrate GMP

28300-74-5

388715

Calcium acetate anhydrous GMP

62-54-4

382110

Calcium hydrogenphosphate anhydrous GMP

7757-93-9

383410

Chromium (III) chloride 6-hydrate GMP

10125-13-0

388115

Zinc acetate 2-hydrate GMP

5970-45-6

351244R0-CEP 2018-117-Rev 01

Zinc oxide GMP

1314-13-2

304814

Cobalt (II) chloride 6-hydrate GMP

7791-13-1

386010

Copper (II) Chloride 2-hydrate GMP

10125-13-0

387843

Copper (II) oxide GMP

1317-38-0

352702

Copper II sulphate 5-hydrate GMP

7758-99-8

380214

Copper(II) hydroxicarbonate(Malaquita) GMP

12069-69-1

353510

Di-sodium hydrogenphosphate 12-hydrate GMP

10039-32-4

351544R0-CEP 2017-233-Rev 02

EDTA, iron (III) sodium salt 3-hydrate

18154-32-0

333310

Iron (III) chloride sol. 10-14% GMP

7705-08-0

382337

L(+)-Tartaric acid GMP

87-69-4

381414

Magnesium acetate 4-hydrate (parenteral) GMP

16674-78-5

353042R0-CEP 2017-280-Rev 00

Magnesium bromide 6-hydrate GMP

16674-78-5

385610

Magnesium fluoride GMP

16674-78-5

355510

Magnesium hydroxide GMP

1309-42-8

384514

Magnesium L-lactate 2-hydrate GMP

18917-93-6

353414

Manganese carbonate precipitated GMP

598-62-9

352310

Manganese (II) chloride 4-hydrate GMP

13446-34-9

354115

Nickel sulfate 6-hydrate GMP

10101-97-0

387543

Phenol GMP

108-95-2

352610

Potassium acetate GMP

127-08-2

387144R0-CEP 2018-028-Rev 00

Potassium bromide GMP

7758-02-3

351814

Potassium bromide GMP Crystal.

7758-02-3

371414

Potassium chlorate GMP

3811-04-9

384610

Potassium iodate GMP

7758-05-6

386811

Sodium acetate 3-hydrate GMP

6131-90-4

350944R0-CEP 2018-100-Rev 00

Sodium dihydrogen phosphate anhydrous GMP

7558-80-7

382015

Sodium dihydrogenphosphate 1-hydrate GMP

10049-21-5

351015

Sodium dihydrogenphosphAte 2-hydrate GMP

10028-24-7

351142R0-CEP 2017-177-Rev 02

Sodium fluoride GMP

7681-49-4

353314R1-CEP 2016-103-Rev 00

Sodium molybdate 2-hydrate GMP

10102-40-6

387614

Sodium molybdate 2-hydrate GMP

10102-40-6

387610

Sodium selenite GMP

10102-18-8

352514

Succinic acid GMP

110-15-6

382216

Tri-sodium citrate 2-hydrate GMP

6132- 04- 3

383215

Urea GMP

57-13-6

381114

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:

CODE PRODUCT CAS NUMBER
385910

ACETIC ACID 33% w/w GMP QP

64-19-7

384110

ACETIC ACID 80% w/w GMP QP

64-19-7

350214

ALUMINIUM POTASSIUM SULPHATE 12-HYDRATE GMP PH

7784-24-9

308210

AMINOACETIC ACID (GLYCINE) gmp QP

56-40-6

350314

AMMONIUM CHLORIDE GMP PH

12125-02-9

350310

AMMONIUM CHLORIDE GMP QP

12125-02-9

386915

AMMONIUM MOLYBDATE 4-HYDRATE GMP USP

12054-85-2

305314

BENZOIC ACID gmp PH

65-85-0

383410

CALCIUM HYDROGEN PHOSPHATE ANHYDROUS GMP QP

7757-93-9

388115

CHROMIUM (III) CHLORIDE 6-HYDRATE GMP USP

10060-12-5

388143

CHROMIUM (III) CHLORIDE 6-HYDRATE GMP USP PARENTERAL USE

10060-12-5

305210

CITRIC ACID 1-HYDRATE gmp QP

5949-29-1

386010

COBALT (II) CHLORIDE 6-HYDRATE GMP QP

7791-13-1

353510

COPPER (II) CARBONATE, BASIC (MALACHITE)GMP QP

12069-69-1

387815

COPPER (II) CHLORIDE 2-HYDRATE GMP USP

10125-13-0

387843

COPPER (II) CHLORIDE 2-HYDRATE GMP USP PARENTERAL USE

10125-13-0

352702

COPPER (II) OXIDE GMP PE

1317-38-0

380214

COPPER (II) SULPHATE 5-HYDRATE GMP PH

7758-99-8

380239

COPPER (II) SULPHATE 5-HYDRATE GMP PH MICROBIOLOGICALLY TESTED

7758-99-8

380215

COPPER (II) SULPHATE 5-HYDRATE GMP USP

7758-99-8

382914

COPPER (II) SULPHATE ANHYDROUS GMP PH

7758-98-7

351514

di-SODIUM HYDROGEN PHOSPHATE 12-HYDRATE GMP PH

10039-32-4

351544

di-SODIUM HYDROGEN PHOSPHATE 12-HYDRATE GMP PH PARENTERAL USE

10039-32-4

385310

di-SODIUM HYDROGEN PHOSPHATE 2-HYDRATE GMP QP

10028-24-7

383525

di-SODIUM HYDROGEN PHOSPHATE ANHYDROUS GMP PAB

7558-79-4

383502

di-SODIUM HYDROGEN PHOSPHATE ANHYDROUS GMP PE

7558-79-4

383510

di-SODIUM HYDROGEN PHOSPHATE ANHYDROUS GMP QP

7558-79-4

387744

EDTA, ACID GMP PH PARENTERAL USE

60-00-4

381710

EDTA, ACID GMP QP

60-00-4

387742

EDTA, ACID GMP QP PARENTERAL USE

60-00-4

351414

EDTA, DISODIUM SALT 2-HYDRATE GMP PH

6381-92-6

351410

EDTA, DISODIUM SALT 2-HYDRATE GMP QP

6381-92-6

306116

FUMARIC ACID gmp NF

110-17-8

306110

FUMARIC ACID gmp QP

110-17-8

350014

IRON (II) CHLORIDE 4-HYDRATE GMP PH

13478-10-9

382360

IRON (III) CHLORIDE SOL. 10-14% Fe w/w GMP PA

7705-08-0

382302

IRON (III) CHLORIDE SOL. 10-14% Fe w/w GMP PE

7705-08-0

382337

IRON (III) CHLORIDE SOL. 10-14% Fe w/w GMP QP MICROBIOLOGICALLY TESTED

7705-08-0

382305

IRON (III) CHLORIDE SOL. 10-14% Fe w/w GMP RE

7705-08-0

380315

IRON (II) SULPHATE 7-HYDRATE GMP USP

7782-63-0

352914

iso-PROPYL ALCOHOL GMP PH

67-63-0

352910

iso-PROPYL ALCOHOL GMP QP

67-63-0

381414

L(+)-TARTARIC ACID GMP PH

87-69-4

381410

L(+)-TARTARIC ACID GMP QP

87-69-4

353042

MAGNESIUM ACETATE 4-HYDRATE GMP QP PARENTERAL USE

16674-78-5

385610

MAGNESIUM BROMIDE 6-HYDRATE GMP QP

13446-53-2

355510

MAGNESIUM FLUORIDE GMP QP

7783-40-6

384514

MAGNESIUM HYDROXIDE GMP PH

1309-42-8

353414

MAGNESIUM L-LACTATE 2-HYDRATE GMP PH

18917-93-6

352310

MANGANESE CARBONATE PRECIPITATED GMP QP

598-62-9

352342

MANGANESE CARBONATE PRECIPITATED GMP QP PARENTERAL USE

598-62-9

354115

MANGANESE (II) CHLORIDE 4-HYDRATE GMP USP

13446-34-9

352610

PHENOL GMP QP

108-95-2

387144

POTASSIUM ACETATE GMP PH PARENTERAL USE

127-08-2

371414

POTASSIUM BROMIDE GMP Crystal. PH

7758-02-3

351814

POTASSIUM BROMIDE GMP PH

7758-02-3

386402

POTASSIUM CARBONATE ANHYDROUS, GRANULATED GMP PE

584-08-7

384610

POTASSIUM CHLORATE GMP QP

3811-04-9

386514

POTASSIUM HYDROGEN CARBONATE GMP PH

298-14-6

386510

POTASSIUM HYDROGEN CARBONATE GMP QP

298-14-6

386811

POTASSIUM IODATE GMP FCC

7758-05-6

350110

POTASSIUM NITRATE GMP QP

7757-79-1

350944

SODIUM ACETATE 3-HYDRATE GMP PH PARENTERAL USE

6131-90-4

306002

SODIUM CHLORIDE gmp PE

7647-14-5

306014

SODIUM CHLORIDE gmp PH

7647-14-5

306010

SODIUM CHLORIDE gmp QP

7647-14-5

351015

SODIUM DIHYDROGEN PHOSPHATE 1-HYDRATE GMP USP

10049-21-5

351114

SODIUM DIHYDROGEN PHOSPHATE 2-HYDRATE GMP PH

13472-35-0

351110

SODIUM DIHYDROGEN PHOSPHATE 2-HYDRATE GMP QP

13472-35-0

351142

SODIUM DIHYDROGEN PHOSPHATE 2-HYDRATE GMP QP PARENTERAL USE

13472-35-0

382015

SODIUM DIHYDROGEN PHOSPHATE ANHYDROUS GMP USP

7558-80-7

353314

SODIUM FLUORIDE GMP PH

7681-49-4

353310

SODIUM FLUORIDE GMP QP

7681-49-4

386130

SODIUM HYDROXIDE 0.1M GMP DV

1310-73-2

386230

SODIUM HYDROXIDE 0.5M GMP DV

1310-73-2

386330

SODIUM HYDROXIDE 0.5M/SODIUM CHLORIDE 0.5M GMP DV

.

384930

SODIUM HYDROXIDE 2M/SODIUM CHLORIDE 2M GMP DV

.

384830

SODIUM HYDROXIDE 3M GMP DV

1310-73-2

301314

SODIUM HYDROXIDE, PELLETS gmp PH

1310-73-2

301310

SODIUM HYDROXIDE, PELLETS gmp QP

1310-73-2

384050

SODIUM HYDROXIDE SOL.32% w/w GMP DE

1310-73-2

384002

SODIUM HYDROXIDE SOL.32% w/w GMP PE

1310-73-2

384007

SODIUM HYDROXIDE SOL.32% w/w GMP PRS

1310-73-2

384305

SODIUM HYDROXIDE SOL.50% w/w GMP RE

1310-73-2

387614

SODIUM MOLYBDATE 2-HYDRATE GMP PH

10102-40-6

387644

SODIUM MOLYBDATE 2-HYDRATE GMP PH PARENTERAL USE

10102-40-6

387610

SODIUM MOLYBDATE 2-HYDRATE GMP QP

10102-40-6

387642

SODIUM MOLYBDATE 2-HYDRATE GMP QP PARENTERAL USE

10102-40-6

352502

SODIUM SELENITE GMP PE

10102-18-8

352514

SODIUM SELENITE GMP PH

10102-18-8

352544

SODIUM SELENITE GMP PH PARENTERAL USE

10102-18-8

352507

SODIUM SELENITE GMP PRS

10102-18-8

352510

SODIUM SELENITE GMP QP

10102-18-8

385110

SODIUM SUCCINATE 6-HYDRATE GMP QP

6106-21-4

380714

SODIUM SULPHATE 10-HYDRATE GMP PH

7727-73-3

380710

SODIUM SULPHATE 10-HYDRATE GMP QP

7727-73-3

380502

SODIUM SULPHATE ANHYDROUS GMP PE

7757-82-6

380514

SODIUM SULPHATE ANHYDROUS GMP PH

7757-82-6

380814

SODIUM THIOSULPHATE 5-HYDRATE GMP PH

10102-17-7

380810

SODIUM THIOSULPHATE 5-HYDRATE GMP QP

10102-17-7

382216

SUCCINIC ACID GMP NF

110-15-6

381210

TIN (II) CHLORIDE 2-HYDRATE GMP QP

10025-69-1

383243

tri-SODIUM CITRATE 2-HYDRATE GMP USP PARENTERAL USE

6132-04-3

381114

UREA GMP PH

57-13-6

381115

UREA GMP USP

57-13-6

351214

ZINC ACETATE 2-HYDRATE GMP PH

5970-45-6

351244

ZINC ACETATE 2-HYDRATE GMP PH PARENTERAL USE

5970-45-6

304814

ZINC OXIDE gmp PH

1314-13-2

353115

ZINC SULPHATE 1-HYDRATE GMP USP

7446-19-7

351314

ZINC SULPHATE 7-HYDRATE GMP PH

7446-20-0

351310

ZINC SULPHATE 7-HYDRATE GMP QP

7446-20-0

351343

ZINC SULPHATE 7-HYDRATE GMP USP PARENTERAL USE

7446-20-0

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
3515

di-sodium hydrogen phosphate 12-H2O parenteral GMP


10039-32-4

3817


EDTA, acid GMP

60-00-4

3514


EDTA, disodium salt 2 hydrate parenteral GMP


6381-92-6

3530


Magnesium acetate 4 hydrate parenteral use GMP


16674-78-5

3871


Potassium acetate parenteral use GMP



127-08-2

3518


Potassium bromide parenteral use GMP


7758-02-3

3402


Potassium dihidrogen phosphate parenteral use GMP



7778-77-0

3509


Sodium acetate 3 hydrate parenteral use GMP


6131-90-4

3511


Sodium dihydrogen phosphate 2 H2O parenteral GMP



13472-35-0

3832


tri-Sodium citrate 2 hydrate parenteral use GMP

6132-04-3

3512


Zinc acetate 2 hydrate parenteral use GMP



5970-45-6