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
352760 COPPER (II) OXIDE GMP PA 1317-38-0
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
340014 di-SODIUM HYDROGEN PHOSPHATE 12-H2O parent.GMP PH 10039-32-4
340010 di-SODIUM HYDROGEN PHOSPHATE 12-H2O parent.GMP QP 10039-32-4
381414 L(+)-TARTARIC ACID GMP PH 87-69-4
381410 L(+)-TARTARIC ACID GMP QP 87-69-4
340714 MAGNESIUM ACETATE 4-HYDRATE parenteral use GMP PH 16674-78-5
340710 MAGNESIUM ACETATE 4-HYDRATE parenteral use GMP QP 16674-78-5
385610 MAGNESIUM BROMIDE 6-HYDRATE GMP QP 13446-53-2
384514 MAGNESIUM HYDROXIDE GMP PH 1309-42-8
384510 MAGNESIUM HYDROXIDE GMP QP 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
340514 POTASSIUM ACETATE parenteral use GMP PH 127-08-2
351814 POTASSIUM BROMIDE GMP PH 7758-02-3
384610 POTASSIUM CHLORATE GMP QP 3811-04-9
350714 POTASSIUM DIHYDROGEN PHOSPHATE GMP PH 7778-77-0
350114 POTASSIUM NITRATE GMP PH 7757-79-1
350110 POTASSIUM NITRATE GMP QP 7757-79-1
340414 SODIUM ACETATE 3-HYDRATE parenteral use GMP PH 6131-90-4
340410 SODIUM ACETATE 3-HYDRATE parenteral use GMP QP 6131-90-4
351014 SODIUM DIHYDROGEN PHOSPHATE 1-HYDRATE GMP PH 10049-21-5
351015 SODIUM DIHYDROGEN PHOSPHATE 1-HYDRATE GMP USP 10049-21-5
340114 SODIUM DIHYDROGEN PHOSPHATE 2-H2O parent. GMP PH 13472-35-0
340110 SODIUM DIHYDROGEN PHOSPHATE 2-H2O parent. GMP QP 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
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
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
341310 tri-SODIUM CITRATE 2-HYDRATE parenteral GMP QP 6132-04-3
341315 tri-SODIUM CITRATE 2-HYDRATE parenteral GMP USP 6132-04-3
381114 UREA GMP PH 57-13-6
341414 ZINC ACETATE 2-HYDRATE parenteral use GMP PH 5970-45-6
341410 ZINC ACETATE 2-HYDRATE parenteral use GMP QP 5970-45-6
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
384110 ACETIC ACID 80% w/w GMP QP 64-19-7
381602 ACETIC ACID GLACIAL GMP PE 64-19-7
381614 ACETIC ACID GLACIAL GMP PH 64-19-7
381610 ACETIC ACID GLACIAL GMP QP 64-19-7
380914 ACETONE GMP PH 67-64-1
380910 ACETONE GMP QP 67-64-1
351715 ALUMINIUM AMMONIUM SULPHATE 12-HYDRATE GMP USP 7784-26-1
352110 ALUMINIUM CHLORIDE 6-HYDRATE GMP QP 7784-13-6
350214 ALUMINIUM POTASSIUM SULPHATE 12-HYDRATE GMP PH 7784-24-9
308210 AMINOACETIC ACID (GLYCINE) gmp QP 56-40-6
353910 AMMONIA AQUEOUS,27-30% w/w (as NH3) GMP QP 1336-21-6
350314 AMMONIUM CHLORIDE GMP PH 12125-02-9
350310 AMMONIUM CHLORIDE GMP QP 12125-02-9
350414 AMMONIUM DIHYDROGEN PHOSPHATE GMP PH 7722-76-1
352216 AMMONIUM SULPHATE GMP NF 7783-20-2
352214 AMMONIUM SULPHATE GMP PH 7783-20-2
305314 BENZOIC ACID gmp PH 65-85-0
383810 BENZYL ALCOHOL GMP QP 100-51-6
383010 BORIC ACID GMP QP 10043-35-3
382114 CALCIUM ACETATE ANHYDROUS GMP PH 62-54-4
382115 CALCIUM ACETATE ANHYDROUS GMP USP 62-54-4
304914 CALCIUM CARBONATE gmp PH 471-34-1
304614 CALCIUM CHLORIDE 2-HYDRATE gmp PH 10035-04-8
383410 CALCIUM HYDROGEN PHOSPHATE ANHYDROUS GMP QP 7757-93-9
305014 CALCIUM HYDROXIDE gmp PH 1305-62-0
383110 CALCIUM HYPOPHOSPHITE GMP QP 7789-79-9
382716 CALCIUM SULPHATE 2-HYDRATE GMP NF 10101-41-4
382710 CALCIUM SULPHATE 2-HYDRATE GMP QP 10101-41-4
341015 CHROMIUM (III) CHLORIDE 6-H2O parenteral GMP USP 10060-12-5
354315 CHROMIUM (III) CHLORIDE 6-HYDRATE GMP USP 10060-12-5
305214 CITRIC ACID 1-HYDRATE gmp PH 5949-29-1
305210 CITRIC ACID 1-HYDRATE gmp QP 5949-29-1
353510 COPPER (II) CARBONATE, BASIC (MALACHITE)GMP QP 12069-69-1
354215 COPPER (II) CHLORIDE 2-HYDRATE GMP USP 10125-13-0
341215 COPPER (II) CHLORIDE 2-HYDRATE parenteral u.GMP US 10125-13-0
352760 COPPER (II) OXIDE GMP PA 1317-38-0
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
304311 D-GLUCOSE ANHYDROUS gmp FCC 50-99-7
304310 D-GLUCOSE ANHYDROUS gmp QP 50-99-7
352010 DIMETIL OXALATE GMP QP 553-90-2
340014 di-SODIUM HYDROGEN PHOSPHATE 12-H2O parent.GMP PH 10039-32-4
340010 di-SODIUM HYDROGEN PHOSPHATE 12-H2O parent.GMP QP 10039-32-4
351514 di-SODIUM HYDROGEN PHOSPHATE 12-HYDRATE GMP PH 10039-32-4
385310 di-SODIUM HYDROGEN PHOSPHATE 2-HYDRATE GMP QP 10028-24-7
350514 di-SODIUM HYDROGEN PHOSPHATE 7-HYDRATE GMP PH 7782-85-6
350515 di-SODIUM HYDROGEN PHOSPHATE 7-HYDRATE GMP USP 7782-85-6
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
351916 di-SODIUM TARTRATE 2-HYDRATE GMP NF 6106-24-7
350614 di-SODIUM TETRABORATE 10-HYDRATE GMP PH 1303-96-4
350615 di-SODIUM TETRABORATE 10-HYDRATE GMP USP 1303-96-4
381714 EDTA, ACID GMP PH 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
340310 EDTA, DISODIUM SALT 2-HYDRATE parenteral GMP QP 6381-92-6
306116 FUMARIC ACID gmp NF 110-17-8
306110 FUMARIC ACID gmp QP 110-17-8
383310 GLUTARALDEHYDE SOLUTION 25% w/w GMP QP 111-30-8
306314 GLYCEROL gmp PH 56-81-5
354414 HYDROCHLORIC ACID 10% w/w GMP PH 7647-01-0
306702 HYDROCHLORIC ACID 37% w/w gmp PE 7647-01-0
306710 HYDROCHLORIC ACID 37% w/w gmp QP 7647-01-0
350014 IRON (II) CHLORIDE 4-HYDRATE GMP PH 13478-10-9
350010 IRON (II) CHLORIDE 4-HYDRATE GMP QP 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
340910 IRON (II) SULPHATE 7-H2O parenteral use GMP QP 7782-63-0
380314 IRON (II) SULPHATE 7-HYDRATE GMP PH 7782-63-0
380310 IRON (II) SULPHATE 7-HYDRATE GMP QP 7782-63-0
352914 iso-PROPYL ALCOHOL GMP PH 67-63-0
352910 iso-PROPYL ALCOHOL GMP QP 67-63-0
384210 iso-PROPYL RUBBING ALCOHOL 70% v/v in water GMP QP 67-63-01
381414 L(+)-TARTARIC ACID GMP PH 87-69-4
381410 L(+)-TARTARIC ACID GMP QP 87-69-4
353014 MAGNESIUM ACETATE 4-HYDRATE GMP PH 16674-78-5
353010 MAGNESIUM ACETATE 4-HYDRATE GMP QP 16674-78-5
340714 MAGNESIUM ACETATE 4-HYDRATE parenteral use GMP PH 16674-78-5
340710 MAGNESIUM ACETATE 4-HYDRATE parenteral use GMP QP 16674-78-5
385610 MAGNESIUM BROMIDE 6-HYDRATE GMP QP 13446-53-2
305114 MAGNESIUM HYDROXIDE CARBONATE, LIGHT gmp PH 39409-82-0
384514 MAGNESIUM HYDROXIDE GMP PH 1309-42-8
384510 MAGNESIUM HYDROXIDE GMP QP 1309-42-8
353414 MAGNESIUM L-LACTATE 2-HYDRATE GMP PH 18917-93-6
381031 MAGNESIUM SULPHATE 7-HYDRATE GMP OMNI 10034-99-8
381014 MAGNESIUM SULPHATE 7-HYDRATE GMP PH 10034-99-8
381010 MAGNESIUM SULPHATE 7-HYDRATE GMP QP 10034-99-8
351614 MALEIC ACID GMP PH 110-16-7
351610 MALEIC ACID GMP QP 110-16-7
352310 MANGANESE CARBONATE PRECIPITATED GMP QP 598-62-9
354115 MANGANESE (II) CHLORIDE 4-HYDRATE GMP USP 13446-34-9
341115 MANGANESE (II) CHLORIDE 4-HYDRATE parent. GMP USP 13446-34-9
352814 MANGANESE (II) SULPHATE 1-HYDRATE GMP PH 10034-96-5
352805 MANGANESE (II) SULPHATE 1-HYDRATE GMP RE 10034-96-5
306802 orto-PHOSPHORIC ACID 85% w/w gmp PE 7664-38-2
306810 orto-PHOSPHORIC ACID 85% w/w gmp QP 7664-38-2
382510 PHENOL 90%, w/w AQUEOUS SOLUTION GMP QP 108-95-2
382515 PHENOL 90%, w/w AQUEOUS SOLUTION GMP USP 108-95-2
352610 PHENOL GMP QP 108-95-2
340514 POTASSIUM ACETATE parenteral use GMP PH 127-08-2
351814 POTASSIUM BROMIDE GMP PH 7758-02-3
340610 POTASSIUM BROMIDE parenteral use GMP QP 7758-02-3
383707 POTASSIUM CARBONATE ANHYDROUS GMP PRS 584-08-7
383710 POTASSIUM CARBONATE ANHYDROUS GMP QP 584-08-7
384610 POTASSIUM CHLORATE GMP QP 3811-04-9
385414 POTASSIUM CHLORIDE, Free-flowing GMP PH 7447-40-7
385410 POTASSIUM CHLORIDE, Free-flowing GMP QP 7447-40-7
381914 POTASSIUM CHLORIDE GMP PH 7447-40-7
381910 POTASSIUM CHLORIDE GMP QP 7447-40-7
350714 POTASSIUM DIHYDROGEN PHOSPHATE GMP PH 7778-77-0
340210 POTASSIUM DIHYDROGEN PHOSPHATE parenteral GMP QP 7778-77-0
381810 POTASSIUM HYDROGEN TARTRATE GMP QP 868-14-4
304714 POTASSIUM HYDROXIDE, PELLETS gmp PH 1310-58-3
383610 POTASSIUM NITRATE free flowing GMP QP 7757-79-1
350114 POTASSIUM NITRATE GMP PH 7757-79-1
350110 POTASSIUM NITRATE GMP QP 7757-79-1
350831 POTASSIUM SULPHATE GMP OMNI 7778-80-5
350814 POTASSIUM SULPHATE GMP PH 7778-80-5
350914 SODIUM ACETATE 3-HYDRATE GMP PH 6131-90-4
350910 SODIUM ACETATE 3-HYDRATE GMP QP 6131-90-4
340414 SODIUM ACETATE 3-HYDRATE parenteral use GMP PH 6131-90-4
340410 SODIUM ACETATE 3-HYDRATE parenteral use GMP QP 6131-90-4
385214 SODIUM BENZOATE GMP PH 532-32-1
385210 SODIUM BENZOATE GMP QP 532-32-1
341514 SODIUM BENZOATE parenteral use GMP PH 532-32-1
341510 SODIUM BENZOATE parenteral use GMP QP 532-32-1
383910 SODIUM BROMIDE GMP QP 7647-15-6
380414 SODIUM CARBONATE 10-HYDRATE GMP PH 6132-02-1
353210 SODIUM CARBONATE ANHYDROUS GMP QP 497-19-8
306002 SODIUM CHLORIDE gmp PE 7647-14-5
306014 SODIUM CHLORIDE gmp PH 7647-14-5
306010 SODIUM CHLORIDE gmp QP 7647-14-5
351014 SODIUM DIHYDROGEN PHOSPHATE 1-HYDRATE GMP PH 10049-21-5
351015 SODIUM DIHYDROGEN PHOSPHATE 1-HYDRATE GMP USP 10049-21-5
340114 SODIUM DIHYDROGEN PHOSPHATE 2-H2O parent. GMP PH 13472-35-0
340110 SODIUM DIHYDROGEN PHOSPHATE 2-H2O parent. GMP QP 13472-35-0
351114 SODIUM DIHYDROGEN PHOSPHATE 2-HYDRATE GMP PH 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
306202 SODIUM HYDROGEN CARBONATE gmp PE 144-55-8
306214 SODIUM HYDROGEN CARBONATE gmp PH 144-55-8
306210 SODIUM HYDROGEN CARBONATE gmp QP 144-55-8
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
381302 SODIUM HYDROXIDE SOL.30% w/w GMP PE 1310-73-2
381307 SODIUM HYDROXIDE SOL.30% w/w GMP PRS 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
384010 SODIUM HYDROXIDE SOL.32% w/w GMP QP 1310-73-2
384302 SODIUM HYDROXIDE SOL.50% w/w GMP PE 1310-73-2
384310 SODIUM HYDROXIDE SOL.50% w/w GMP QP 1310-73-2
354010 SODIUM MOLYBDATE 2-HYDRATE GMP QP 10102-40-6
340814 SODIUM MOLYBDATE 2-HYDRATE parenteral use GMP PH 10102-40-6
340810 SODIUM MOLYBDATE 2-HYDRATE parenteral use GMP QP 10102-40-6
341610 SODIUM SELENATE GMP parenteral use GMP QP 13410-01-0
385510 SODIUM SELENATE GMP QP 13410-01-0
352502 SODIUM SELENITE GMP PE 10102-18-8
352514 SODIUM SELENITE GMP PH 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
382216 SUCCINIC ACID GMP NF 110-15-6
382210 SUCCINIC ACID GMP QP 110-15-6
304414 SUCROSE gmp PH 57-50-1
305614 TALC, WASHED gmp PH 14807-96-6
381214 TIN (II) CHLORIDE 2-HYDRATE GMP PH 10025-69-1
381210 TIN (II) CHLORIDE 2-HYDRATE GMP QP 10025-69-1
382410 TIN (II) CHLORIDE, SOLUTION 25% w/w GMP QP 10025-69-1
304214 TITANIUM DIOXIDE (ANATASE) gmp PH 13463-67-7
304210 TITANIUM DIOXIDE (ANATASE) gmp QP 13463-67-7
383210 tri-SODIUM CITRATE 2-HYDRATE GMP QP 6132-04-3
341310 tri-SODIUM CITRATE 2-HYDRATE parenteral GMP QP 6132-04-3
341315 tri-SODIUM CITRATE 2-HYDRATE parenteral GMP USP 6132-04-3
381114 UREA GMP PH 57-13-6
351214 ZINC ACETATE 2-HYDRATE GMP PH 5970-45-6
341414 ZINC ACETATE 2-HYDRATE parenteral use GMP PH 5970-45-6
341410 ZINC ACETATE 2-HYDRATE parenteral use GMP QP 5970-45-6
353710 ZINC CHLORIDE SOLUTION 63% w/w GMP QP 7646-85-7
304814 ZINC OXIDE gmp PH 1314-13-2
353110 ZINC SULPHATE 1-HYDRATE GMP QP 7446-19-7
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
351315 ZINC SULPHATE 7-HYDRATE GMP USP 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