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 ASMF |
|---|---|---|---|---|---|
| L(+)-Tartaric acid GMP | 87-69-4 | 381414 |  | ||
| Calcium hydrogenphosphate anhydrous GMP | 7757-93-9 | 383410 | | ||
| Cinc acetate 2-hydrate (parenteral) GMP | 5970-45-6 | 351244 | R0-CEP 2018-117-Rev 00 | ||
| Cinc oxide GMP | 1314-13-2 | 304814 | | |
|
| Copper (II) oxide GMP | 1317-38-0 | 352702 | | ||
| Copper (II) sulfate anhydrous GMP | 7758-98-7 | 382914 | | ||
| Copper II sulphate 5-hydrate GMP | 7758-99-8 | 380214 | | ||
| Copper(II) hydroxicarbonate(Malaquita) GMP | 12069-69-1 | 353510 | | |
|
| Di-sodium hydrogenphosphate 12-hydrate (parenteral) GMP | 10039-32-4 | 351544 | R0-CEP 2017-233-Rev 00 | ||
| Magnesium acetate 4-hydrate (parenteral) GMP | 16674-78-5 | 353042 | R0-CEP 2017-280-Rev 00 | ||
| Magnesium bromide 6-hydrate GMP QP | 16674-78-5 | 385610 | | ||
| Magnesium fluoride GMP QP | 16674-78-5 | 385710 | | ||
| 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 | | |
|
| Phenol GMP | 108-95-2 | 352610 | | ||
| Potassium acetate (parenteral) GMP | 127-08-2 | 387144 | R0-CEP 2018-028-Rev 00 | ||
| Potassium bromide GMP | 7758-02-3 | 351814 | | ||
| Potassium chlorate GMP | 3811-04-9 | 384610 | | ||
| Sodium acetate 3-hydrate (parenteral) GMP | 6131-90-4 | 350944 | R0-CEP 2018-100-Rev 00 | ||
| Sodium dihydrogen phosphate anhydrous GMP USP | 7558-80-7 | 382015 | | ||
| Sodium dihydrogenphosphate 1-hydrate GMP | 10049-21-5 | 351015 | | ||
| Sodium dihydrogenphosphate 2-hydrate (parenteral) GMP | 10028-24-7 | 351142 | R0-CEP 2017-177-Rev 00 | ||
| Sodium fluoride GMP PH | 7681-49-4 | 353314 | R0-CEP 2016-103-Rev 01 | ||
| Sodium molybdate 2-hydrate GMP | 10102-40-6 | 354010 | | ||
| Sodium selenite GMP PH | 10102-18-8 | 352514 | | |
|
| Succinic acid | 110-15-6 | 382216 | | ||
| Tri-sodium citrate 2-hydrate GMP | 6132- 04- 3 | 383243 | |
||
| 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 |
| 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 |
| 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 |
| 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 |
| 353042 | MAGNESIUM ACETATE 4-HYDRATE GMP QP PARENTERAL USE | 16674-78-5 |
| 385610 | MAGNESIUM BROMIDE 6-HYDRATE GMP QP | 13446-53-2 |
| 385710 | 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 |
| 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 |
| 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 |
| 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 |
| 382216 | SUCCINIC ACID GMP NF | 110-15-6 |
| 381214 | TIN (II) CHLORIDE 2-HYDRATE GMP PH | 10025-69-1 |
| 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 |
| 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.
| CODE | PRODUCT | CAS Number |
|---|---|---|
| 3400 | di-sodium hydrogen phosphate 12-H2O parenteral GMP | 10039-32-4 |
| 3403 | EDTA, disodium salt 2 hydrate parenteral GMP | 6381-92-6 |
| 3407 | Magnesium acetate 4 hydrate parenteral use GMP | 16674-78-5 |
| 3405 | Potassium acetate parenteral use GMP | 127-08-2 |
| 3406 | Potassium bromide parenteral use GMP | 7758-02-3 |
| 3402 | Potassium dihidrogen phosphate parenteral use GMP | 7778-77-0 |
| 3404 | Sodium acetate 3 hydrate parenteral use GMP | 6131-90-4 |
| 3401 | Sodium dihydrogen phosphate 2 H2O parenteral GMP | 13472-35-0 |
| 3413 | tri-Sodium citrate 2 hydrate parenteral use GMP | 6132-04-3 |
| 3414 | Zinc acetate 2 hydrate parenteral use GMP | 5970-45-6 |
