Pharmaceutical raw materials of highest standard

Trust the expertise of a raw materials specialist for pharmaceutical products with more than 30 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
  • enteral diet
  • tablets
  • suppositories
  • semi-solid preparations
  • parenteralia
  • dermal applications
  • whitemaker

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 workmanship 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 drug approval
  • audit report available at MAGNESIA for customer evaluation and approval
  • reliable delivery source / supply reliability
  • best support from MAGNESIA and manufacturer for drug 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 drug approval
  • audit reports available for customer evaluation and approval

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

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,
  • 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.

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.

Contact us

Trade compliance ensures quality of your products

As an expert in the procurement of additives, active ingredients and excipients, compliance with applicable laws for import and export as well as compliance with trade and customs laws is an important pillar of our specialization. We also work closely with our customers to determine the applicable export control restrictions. So there are no surprises to be expected with urgently needed raw material deliveries.

Awarded as certified partner

MAGNESIA undergoes regular audits and controls by supervisory authorities. As a distributor of active ingredients, our quality management system for trading in active ingredients for the manufacture of human pharmaceuticals is GDP-certified. In general, our quality management is certified in accordance with DIN EN ISO 9001. In addition, our hygiene management complies with the food safety system standard based on HACCP.