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.

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:

CODE PRODUCT CAS NUMBER
383410 CALCIUM HYDROGEN PHOSPHATE ANHYDROUS GMP QP 7757-93-9
353510 COPPER (II) CARBONATE, BASIC (MALACHITE)GMP QP 12069-69-1
352702 COPPER (II) OXIDE GMP PE 1317-38-0
380214 COPPER (II) SULPHATE 5-HYDRATE GMP PH 7758-99-8
380215 COPPER (II) SULPHATE 5-HYDRATE GMP USP 7758-99-8
382914 COPPER (II) SULPHATE ANHYDROUS GMP PH 7758-98-7
381414 L(+)-TARTARIC ACID GMP PH 87-69-4
381410 L(+)-TARTARIC ACID GMP QP 87-69-4
385610 MAGNESIUM BROMIDE 6-HYDRATE GMP QP 13446-53-2
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
352610 PHENOL GMP QP 108-95-2
387144 POTASSIUM ACETATE GMP PH PARENTERAL USE 127-08-2
351814 POTASSIUM BROMIDE GMP PH 7758-02-3
384610 POTASSIUM CHLORATE GMP QP 3811-04-9
350110 POTASSIUM NITRATE GMP QP 7757-79-1
351015 SODIUM DIHYDROGEN PHOSPHATE 1-HYDRATE GMP USP 10049-21-5
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
354010 SODIUM MOLYBDATE 2-HYDRATE GMP QP 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
380714 SODIUM SULPHATE 10-HYDRATE GMP PH 7727-73-3
380710 SODIUM SULPHATE 10-HYDRATE GMP QP 7727-73-3
381114 UREA GMP PH 57-13-6
304814 ZINC OXIDE gmp PH 1314-13-2

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 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
305314 BENZOIC ACID gmp PH 65-85-0
383410 CALCIUM HYDROGEN PHOSPHATE ANHYDROUS GMP QP 7757-93-9
383110 CALCIUM HYPOPHOSPHITE GMP QP 7789-79-9
305210 CITRIC ACID 1-HYDRATE gmp QP 5949-29-1
353510 COPPER (II) CARBONATE, BASIC (MALACHITE)GMP QP 12069-69-1
352702 COPPER (II) OXIDE GMP PE 1317-38-0
380214 COPPER (II) SULPHATE 5-HYDRATE GMP PH 7758-99-8
380215 COPPER (II) SULPHATE 5-HYDRATE GMP USP 7758-99-8
382914 COPPER (II) SULPHATE ANHYDROUS GMP PH 7758-98-7
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
381744 EDTA, ACID GMP PH PARENTERAL USE 60-00-4
381742 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
306110 FUMARIC ACID gmp QP 110-17-8
383310 GLUTARALDEHYDE SOLUTION 25% w/w GMP QP 111-30-8
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
382305 IRON (III) CHLORIDE SOL. 10-14% Fe w/w GMP RE 7705-08-0
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
385610 MAGNESIUM BROMIDE 6-HYDRATE GMP QP 13446-53-2
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
354142 MANGANESE (II) CHLORIDE 4-HYDRATE GMP QP PARENTERAL USE 13446-34-9
352610 PHENOL GMP QP 108-95-2
387144 POTASSIUM ACETATE GMP PH PARENTERAL USE 127-08-2
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
350110 POTASSIUM NITRATE GMP QP 7757-79-1
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
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
354010 SODIUM MOLYBDATE 2-HYDRATE GMP QP 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
381214 TIN (II) CHLORIDE 2-HYDRATE GMP PH 10025-69-1
381210 TIN (II) CHLORIDE 2-HYDRATE GMP QP 10025-69-1
381114 UREA GMP PH 57-13-6
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

Parenteral Excipients & API

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