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:
| Product | CAS No. | Code | EU ASMF | CEP | US DMF |
|---|---|---|---|---|---|
Acetic Acid 80% w/w GMP | 64-19-7 | 384110 |  | ||
Ammonium chloride GMP | 12125-02-9 | 350314 | R0-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 | 351244 | R0-CEP 2018-177-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 | 351544 | 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 | 353042 | R0-CEP 2017-280-Rev 01 | ||
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 | 387144 | CEP 2018-028-Rev 01 | ||
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 | 350944 | CEP 2018-100-Rev 01 | ||
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 | 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 | | ||
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 PH.EUR.11ED. |
7784-24-9 |
| 308210 | AMINOACETIC ACID (GLYCINE) gmp QP PH.EUR.11ED. |
56-40-6 |
| 350314 | AMMONIUM CHLORIDE GMP PH PH.EUR.11ED. |
12125-02-9 |
| 350310 | AMMONIUM CHLORIDE GMP QP PH.EUR.11ED.,USP-NF 2022 |
12125-02-9 |
| 386915 | AMMONIUM MOLYBDATE 4-HYDRATE GMP USP USP-NF 2022 |
12054-85-2 |
| 305314 | BENZOIC ACID gmp PH PH.EUR.11ED. |
65-85-0 |
| 308814 | BENZYL ALCOHOL GMP PH |
100-51-6 |
| 383410 | CALCIUM HYDROGEN PHOSPHATE ANHYDROUS GMP QP JP 16,PH.EUR.11ED.,USP-NF 2022 |
7757-93-9 |
| 388143 | CHROMIUM (III) CHLORIDE 6-HYDRATE GMP USP PARENTERAL USE USP-NF 2022 |
10060-12-5 |
| 388115 | CHROMIUM (III) CHLORIDE 6-HYDRATE GMP USP USP-NF 2022 |
10060-12-5 |
| 305210 | CITRIC ACID 1-HYDRATE gmp QP CNFSS,PH.EUR.11ED.,USP-NF 2022 |
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 |
| 387843 | COPPER (II) CHLORIDE 2-HYDRATE GMP USP PARENTERAL USE USP-NF 2022 |
10125-13-0 |
| 387815 | COPPER (II) CHLORIDE 2-HYDRATE GMP USP USP-NF 2022 |
10125-13-0 |
| 352702 | COPPER (II) OXIDE GMP PE |
1317-38-0 |
| 380239 | COPPER (II) SULPHATE 5-HYDRATE GMP PH MICROBIOLOGICALLY TESTED PH.EUR.11ED. |
7758-99-8 |
| 380214 | COPPER (II) SULPHATE 5-HYDRATE GMP PH PH.EUR.11ED. |
7758-99-8 |
| 380215 | COPPER (II) SULPHATE 5-HYDRATE GMP USP USP-NF 2022 |
7758-99-8 |
| 382914 | COPPER (II) SULPHATE ANHYDROUS GMP PH PH.EUR.11ED. |
7758-98-7 |
| 351544 | di-SODIUM HYDROGEN PHOSPHATE 12-HYDRATE GMP PH PARENTERAL USE PH.EUR.11ED. |
10039-32-4 |
| 351514 | di-SODIUM HYDROGEN PHOSPHATE 12-HYDRATE GMP PH PH.EUR.11ED. |
10039-32-4 |
| 385310 | di-SODIUM HYDROGEN PHOSPHATE 2-HYDRATE GMP QP PH.EUR.11ED.,USP-NF 2022 |
10028-24-7 |
| 383525 | di-SODIUM HYDROGEN PHOSPHATE ANHYDROUS GMP PAB PH.EUR.11ED.,USP-NF 2022 |
7558-79-4 |
| 383502 | di-SODIUM HYDROGEN PHOSPHATE ANHYDROUS GMP PE PH.EUR.11ED.,USP-NF 2022 |
7558-79-4 |
| 383510 | di-SODIUM HYDROGEN PHOSPHATE ANHYDROUS GMP QP PH.EUR.11ED.,USP-NF 2022 |
7558-79-4 |
| 387744 | EDTA, ACID GMP PH PARENTERAL USE PH.EUR.11ED. |
60-00-4 |
| 387742 | EDTA, ACID GMP QP PARENTERAL USE PH.EUR.11ED.,USP-NF 2023 |
60-00-4 |
| 381710 | EDTA, ACID GMP QP USP-NF 2022,PH.EUR.11ED. |
60-00-4 |
| 351414 | EDTA, DISODIUM SALT 2-HYDRATE GMP PH PH.EUR.11ED. |
6381-92-6 |
| 351410 | EDTA, DISODIUM SALT 2-HYDRATE GMP QP PH.EUR.11ED.,USP-NF 2022 |
6381-92-6 |
| 306116 | FUMARIC ACID gmp NF USP-NF 2022 |
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 |
| 382304 | IRON (III) CHLORIDE SOL. 10-14% Fe w/w GMP PS |
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 USP-NF 2022 |
7782-63-0 |
| 352914 | iso-PROPYL ALCOHOL GMP PH PH.EUR.11ED. |
67-63-0 |
| 352910 | iso-PROPYL ALCOHOL GMP QP PH.EUR.11ED.,USP-NF 2022 |
67-63-0 |
| 381414 | L(+)-TARTARIC ACID GMP PH PH.EUR.11ED. |
87-69-4 |
| 381410 | L(+)-TARTARIC ACID GMP QP PH.EUR.11ED.,USP-NF 2022 |
87-69-4 |
| 353042 | MAGNESIUM ACETATE 4-HYDRATE GMP QP PARENTERAL USE PH.EUR.11ED. |
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 PH.EUR.11ED. |
1309-42-8 |
| 353414 | MAGNESIUM L-LACTATE 2-HYDRATE GMP PH PH.EUR.11ED. |
18917-93-6 |
| 352310 | MANGANESE CARBONATE PRECIPITATED GMP QP |
598-62-9 |
| 352342 | MANGANESE CARBONATE PRECIPITATED GMP QP PARENTERAL USE |
598-62-9 |
| 354142 | MANGANESE (II) CHLORIDE 4-HYDRATE GMP QP PARENTERAL USE USP-NF 2022 |
13446-34-9 |
| 354115 | MANGANESE (II) CHLORIDE 4-HYDRATE GMP USP USP-NF 2025 |
13446-34-9 |
| 352811 | MANGANESE (II) SULPHATE 1-HYDRATE GMP FCC |
10034-96-5 |
| 352602 | PHENOL GMP PE PH.EUR.11ED.,USP-NF 2025 |
108-95-2 |
| 352610 | PHENOL GMP QP PH.EUR.11ED.,USP-NF 2022 |
108-95-2 |
| 371310 | POTASSIUM ACETATE GMP (low Na) QP PH.EUR.11ED.,USP-NF 2022 |
127-08-2 |
| 387144 | POTASSIUM ACETATE GMP PH PARENTERAL USE PH.EUR.11ED. |
127-08-2 |
| 371414 | POTASSIUM BROMIDE GMP Crystal. PH PH.EUR.11ED. |
7758-02-3 |
| 351814 | POTASSIUM BROMIDE GMP PH PH.EUR.11ED. |
7758-02-3 |
| 386402 | POTASSIUM CARBONATE ANHYDROUS, GRANULATED GMP PE PH.EUR.11ED. |
584-08-7 |
| 384610 | POTASSIUM CHLORATE GMP QP |
3811-04-9 |
| 350710 | POTASSIUM DIHYDROGEN PHOSPHATE GMP QP PH.EUR.11ED.,USP-NF 2022 |
7778-77-0 |
| 386514 | POTASSIUM HYDROGEN CARBONATE GMP PH PH.EUR.11ED. |
298-14-6 |
| 386510 | POTASSIUM HYDROGEN CARBONATE GMP QP PH.EUR.11ED.,USP-NF 2022 |
298-14-6 |
| 386811 | POTASSIUM IODATE GMP FCC FCC XIII |
7758-05-6 |
| 350110 | POTASSIUM NITRATE GMP QP |
7757-79-1 |
| 350807 | POTASSIUM SULPHATE GMP PRS |
7778-80-5 |
| 350944 | SODIUM ACETATE 3-HYDRATE GMP PH PARENTERAL USE PH.EUR.11ED. |
6131-90-4 |
| 350910 | SODIUM ACETATE 3-HYDRATE GMP QP PH.EUR.11ED.,USP-NF 2022 |
6131-90-4 |
| 306002 | SODIUM CHLORIDE gmp PE CP 2010,JP 16,PH.EUR.11ED.,USP-NF 2022 |
7647-14-5 |
| 306014 | SODIUM CHLORIDE gmp PH JP 16,PH.EUR.11ED.,USP-NF 2022 |
7647-14-5 |
| 306010 | SODIUM CHLORIDE gmp QP JP 16,PH.EUR.11ED.,USP-NF 2022 |
7647-14-5 |
| 351043 | SODIUM DIHYDROGEN PHOSPHATE 1-HYDRATE GMP USP PARENTERAL USE USP-NF 2022 |
10049-21-5 |
| 351015 | SODIUM DIHYDROGEN PHOSPHATE 1-HYDRATE GMP USP USP-NF 2022 |
10049-21-5 |
| 351114 | SODIUM DIHYDROGEN PHOSPHATE 2-HYDRATE GMP PH PH.EUR.11ED. |
13472-35-0 |
| 351142 | SODIUM DIHYDROGEN PHOSPHATE 2-HYDRATE GMP QP PARENTERAL USE PH.EUR.11ED. |
13472-35-0 |
| 351110 | SODIUM DIHYDROGEN PHOSPHATE 2-HYDRATE GMP QP PH.EUR.11ED.,USP-NF 2022 |
13472-35-0 |
| 382015 | SODIUM DIHYDROGEN PHOSPHATE ANHYDROUS GMP USP USP-NF 2022 |
7558-80-7 |
| 353314 | SODIUM FLUORIDE GMP PH PH.EUR.11ED. |
7681-49-4 |
| 353310 | SODIUM FLUORIDE GMP QP PH.EUR.11ED.,USP-NF 2022 |
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 PH.EUR.11ED. |
1310-73-2 |
| 301310 | SODIUM HYDROXIDE, PELLETS gmp QP PH.EUR.11ED.,USP-NF 2022 |
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 |
| 384004 | SODIUM HYDROXIDE SOL.32% w/w GMP PS |
1310-73-2 |
| 384305 | SODIUM HYDROXIDE SOL.50% w/w GMP RE |
1310-73-2 |
| 387644 | SODIUM MOLYBDATE 2-HYDRATE GMP PH PARENTERAL USE PH.EUR.11ED. |
10102-40-6 |
| 387614 | SODIUM MOLYBDATE 2-HYDRATE GMP PH PH.EUR.11ED. |
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 PH.EUR.11ED. |
10102-18-8 |
| 352544 | SODIUM SELENITE GMP PH PARENTERAL USE PH.EUR.11ED. |
10102-18-8 |
| 352514 | SODIUM SELENITE GMP PH PH.EUR.11ED. |
10102-18-8 |
| 352507 | SODIUM SELENITE GMP PRS CNFSS,PH.EUR.11ED. |
10102-18-8 |
| 352510 | SODIUM SELENITE GMP QP BP-VET 2012 |
10102-18-8 |
| 385110 | SODIUM SUCCINATE 6-HYDRATE GMP QP USP-NF 2022 |
6106-21-4 |
| 380714 | SODIUM SULPHATE 10-HYDRATE GMP PH PH.EUR.11ED. |
7727-73-3 |
| 380710 | SODIUM SULPHATE 10-HYDRATE GMP QP PH.EUR.11ED.,USP-NF 2022 |
7727-73-3 |
| 380502 | SODIUM SULPHATE ANHYDROUS GMP PE PH.EUR.11ED. |
7757-82-6 |
| 380514 | SODIUM SULPHATE ANHYDROUS GMP PH PH.EUR.11ED. |
7757-82-6 |
| 380814 | SODIUM THIOSULPHATE 5-HYDRATE GMP PH PH.EUR.11ED. |
10102-17-7 |
| 380810 | SODIUM THIOSULPHATE 5-HYDRATE GMP QP PH.EUR.11ED.,USP-NF 2022 |
10102-17-7 |
| 382216 | SUCCINIC ACID GMP NF USP-NF 2024 |
110-15-6 |
| 382246 | SUCCINIC ACID GMP PE MICROBIOLOGICALLY TESTED ACS 11 ED.,CHP,JPE,USP-NF 2024 |
110-15-6 |
| 381210 | TIN (II) CHLORIDE 2-HYDRATE GMP QP |
10025-69-1 |
| 383244 | tri-SODIUM CITRATE 2-HYDRATE GMP PH PARENTERAL USE PH.EUR.11ED. |
6132-04-3 |
| 383243 | tri-SODIUM CITRATE 2-HYDRATE GMP USP PARENTERAL USE USP-NF 2022 |
6132-04-3 |
| 381114 | UREA GMP PH PH.EUR.11ED. |
57-13-6 |
| 381115 | UREA GMP USP USP-NF 2022 |
57-13-6 |
| 351244 | ZINC ACETATE 2-HYDRATE GMP PH PARENTERAL USE PH.EUR.11ED. |
5970-45-6 |
| 351214 | ZINC ACETATE 2-HYDRATE GMP PH PH.EUR.11ED. |
5970-45-6 |
| 304814 | ZINC OXIDE gmp PH PH.EUR.11ED. |
1314-13-2 |
| 353115 | ZINC SULPHATE 1-HYDRATE GMP USP USP-NF 2024 |
7446-19-7 |
| 351314 | ZINC SULPHATE 7-HYDRATE GMP PH PH.EUR.11ED. |
7446-20-0 |
| 351310 | ZINC SULPHATE 7-HYDRATE GMP QP PH.EUR.11ED.,USP-NF 2022 |
7446-20-0 |
| 351343 | ZINC SULPHATE 7-HYDRATE GMP USP PARENTERAL USE USP-NF 2022 |
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.
| CODE | PRODUCT | CAS Number |
|---|---|---|
| 3515 | di-sodium hydrogen phosphate 12-H2O parenteral GMP | 10039-32-4 |
| 3817 |
| 60-00-4 |
| 3514 |
| 6381-92-6 |
| 3530 |
| 16674-78-5 |
| 3871 |
| 127-08-2 |
| 3518 |
| 7758-02-3 |
| 3402 |
| 7778-77-0 |
| 3509 |
| 6131-90-4 |
| 3511 |
| 13472-35-0 |
| 3832 |
| 6132-04-3 |
| 3512 |
| 5970-45-6 |
