Pharma
Pharmaceutical raw materials of highest standard
Trust the expertise of a raw materials specialist for pharmaceutical products with more than 40 years of international experience. As a proven partner of the pharmaceutical industry, MAGNESIA provides high-quality minerals and corresponding compounds based on magnesium and calcium, as well as other mineral products such as potassium, sodium and zinc compounds. As a certified distributor of active ingredients, we always keep an eye on the requirements of the respective countries for the production and registration of pharmaceutical products. Of course, MAGNESIA products comply with applicable quality regulations and requirements of Good Manufacturing Practice (GMP) as well as Good Distribution Practice (GDP).
With MAGNESIA you will benefit from a seamless supply chain for optimal productivity.
A wide range of applications for your medicines
Depending on the product format, consistency and pharmaceutical purpose, our high-quality minerals can be used as excipients or active ingredients in a wide range of pharmaceutical applications, as for
peroral applications
suppositories
dermal applications
enteral diet
semi-solid preparations
whitemaker
tablets
parenteralia
Is your product still in the development phase? In this case, please take advantage of integrating the MAGNESIA consulting team into the process at an early stage. We think along, so that you can start production smoothly.
High-quality components: A sound base for safe medicines
Calcium, magnesium and other minerals for your medicines are available at MAGNESIA in the desired quality and quantity. Detailed specifications, safety data sheets and product samples will be sent to you on request.
Please take the following examples to get an idea of your product options:
MagGran® products
Description
These compacted mineral salt agglomerates are available in two versions:
- without any additional additives (MagGran®) or
- enriched with binders* (MagGran®plus) such as corn starch, maltodextrin or PVP
Benefits
MagGran® granules enable optimal processing and best product quality
*The version with binders currently can only be used as an excipient, but as such of unrestricted high quality for the processing and the production process.
Precipitated calcium carbonate as excipient for tablets/solid forms
Description
- corresponds to common pharmacopoeias such as EP or USP and JP
- manufactured in a qualified manufacturing process
- extensive documentation available for use as excipient
Benefits
- constant and documented product quality for customer evaluation and approval
- reliable delivery source / supply reliability
Precipitated calcium carbonate for use as active ingredient
Description
- corresponds to common pharmacopoeias such as EP or USP and JP
- manufactured in a manufacturer’s factory qualified and audited by MAGNESIA
- certified according to Part II EU-GMP Guideline by local supervisory authority
- documentation available for use as active ingredient
Benefits
- constant and documented product quality
- documents available for pharmaceutical approval
- audit report available at MAGNESIA for customer evaluation and approval
- reliable delivery source / supply reliability
- best support from MAGNESIA and manufacturer for pharmaceutical approval
High-purity and free-flowing magnesium hydroxide as raw material for high-purity magnesium salts
Description
- natural and unrestricted source of raw materials
Benefits
- reliable and competitive manufacturer
- constant product quality, especially with regard to elemental impurities according to ICH-Q3D
- high purity raw material at a competitive price
Precipitated calcium carbonate, magnesium carbonate extra light and tri-calcium citrate as TiO2 substitute for use as whitener
Description
- corresponds to common pharmacopoeias such as EP or USP
- manufactured in a qualified manufacturing process
- extensive documentation available for use as excipient
Benefits
- safe alternative to TiO2, which is suspected to be a carcinogenic substance
- smooth marketing of corresponding products
- reliable delivery source / supply reliability
Magnesium stearate vegetabil as excipient
Description
- meets current market and regulatory requirements in accordance with GMP, EP, USP, FCC and others
- meets requirements for halal products as well as kosher products
Benefits
- registered as pharmaceutical excipient in China
- detailed data on elemental impurities according to ICH-Q3D available
- excellent documentation
- comprehensive support with regard to regulatory issues and increasing quality requirements for excipients
Magnesium oxide for use as excipient (in tablet production) or active ingredient
Description
- corresponds to common pharmacopoeias such as EP or USP and JP
- made from seawater or raw material from the Dead Sea
- wide range of qualified and audited manufacturing plants
- qualities partially certified according to Part II EU-GMP-Guideline by local regulatory authority
- documentation for use as active ingredient available
Benefits
- constant and documented product quality
- various bulk weights available in high purity
- documents available for pharmaceutical approval
- audit reports available for customer evaluation and approval
Various pidolates
Description
Binding Minerals and Trace Elements to PCA (Pidolic acid, Pyrrolidone carboxylic acid) creates an innovative and highly bioavailable molecule called Pidolate.
Benefits
- organic and highly bioavailable
- good solubility and compatibility
Available Pidolates
Calcium pidolate
C10H12N2O6Ca
Calcium content: 13.5 %
Solubility at 20°C: 24
Magnesium pidolate
C10H12N2O6Mg
Magnesium content: 8.5 %
Solubility at 20°C: > 60 %
Manganese pidolate
C10H12N2O6Mn
Manganese content: 17.6 %
Solubility at 20°C: 31
Iron pidolate
C10H12N2O6Fe
Iron content: 17.6 %
Solubility at 20°C: 55
Zinc pidolate
C10H12N2O6Zn
Zinc content: 20.3 %
Solubility at 20°C: 17
SOLABIA
MAGNESIA is the exclusive distributor in the DACH region of Solabia, the specialist in pidolate compounds for the pharma sector.
Focus on ethical, medical and scientific standards
Manufacturers of safe and high-quality pharmaceutical products worldwide rely on our long-standing knowledge. In order to ensure the legally compliant quality of our customers’ products, we consistently keep an eye on the applicable standards of following institutions:
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH)
IPEC Europe
European Directorate for the Quality of Medicines and Health Care (EDQM)
European Medicines Agency (EMA)
European Commission
Contact us now
Thomas Raab and the Pharma team supports you with technical know-how and finds tailor-made solutions for your product idea. Also ask for detailed information about specifications, safety data sheets or material samples.
Supplier qualification as an integrated process
As part of the qualification process of our suppliers, we carry out appropriate audits and ensure that requirements are met. Even after successful qualification, compliance with the regulatory requirements for pharmaceuticals is regularly assessed. Our integrated process ensures that all changes at the supplier that could have an impact on GMP status, manufacturing or test parameters, are checked and approved before implementation.
MAGNESIA makes the difference
MAGNESIA not only offers excellent additives, active ingredients and excipients, but also a comprehensive service that our long-term customers particularly appreciate. Quality management, document management and the necessary certifications and audits of suppliers and products are an integral part of our service. Furthermore
fixed contact persons make the cooperation a real partnership for both sides, which benefits from working hand in hand. In short: We think along with you, and the up-to-dateness of the documents required by quality management is proactively provided,
one of our success principles is called “transparency”. We are happy to comply with the request of our manufacturer partners to disclose the origin of substances and materials ordered,
you will receive already registered products that can be instantly used as active ingredients in your products. We would also be happy if you involve us in new developments as early as possible. Your benefit: New products will be certified and appropriate suppliers will be qualified by us. So you are well prepared for production phase and market entry
seamless monitoring of the supply chain is guaranteed, in particular to meet our due diligence obligations as mineral trader and to make the procurement process and storage as transparent as possible.
short delivery times are a crucial factor for our customers. We, therefore, either use our own warehouse for stocking purposes or a suitably qualified and monitored external warehouse keeper,
MAGNESIA, as a reliable partner, safeguards the intellectual property rights of your products. We treat your trade secrets with absolute confidentiality and the protection of customer data is one of our values.