Contract analytical testing

Chemical and physical testing of APIs, excipients and finished products under GMP.

37 providers with evidence Sourced from law and guidelines · as of 10.11.2026 View providers

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In brief

Contract analytical testing means the chemical and physical testing of active substances, excipients, intermediates and finished medicinal products by an external laboratory. The laboratory tests what the specification requires: usually identity, assay and purity, plus, depending on the product, tests such as water content, dissolution, uniformity or particulate matter. The basis is the test procedures in the marketing authorisation and, where available, the monographs of the European Pharmacopoeia (Ph. Eur.).

What matters to the client in the end is a reliable result on which the Qualified Person (QP) can rely when certifying the batch. The laboratory must therefore not only be able to measure, but also work under GMP, keep its methods under control and handle deviations in a way that can later be traced by a competent authority.

Who needs it

Manufacturers, marketing authorisation holders and importers without their own laboratory or with insufficient capacity, as well as development companies.

Legal basis

Chapters 6 and 7 of the EU GMP Guide, Section 9 of the German manufacturing ordinance (AMWHV), Sections 13 and 14 of the German Medicines Act (AMG) and the European Pharmacopoeia.

Typical scope

Identity, assay and purity according to the specification in the marketing authorisation, supplemented by product-specific tests.

What matters

The GMP status of the laboratory, validated or verified methods and a clear allocation of responsibilities in the contract.

When you need it

The most common case is release testing. Before a batch is placed on the market, it must have been tested using the methods described in the marketing authorisation. Companies that do not run their own quality control laboratory or do not have certain instruments outsource the testing in full or in part.

A second reason is testing of starting materials. The manufacturer of the finished product may rely on test results from the approved supplier, but must at least have the identity of each batch tested itself. A quick identity test is often sufficient, and many companies look for an external laboratory to perform it.

A third reason is importation from third countries. If there is no mutual recognition agreement with the country of origin, each imported batch must undergo, in a Member State, a full qualitative analysis, a quantitative analysis of at least all active substances and all other tests required by the marketing authorisation. In addition, there are special tests, for example for N-nitrosamines or elemental impurities, for which the European Pharmacopoeia contains dedicated chapters (2.5.42 and 2.4.20) and for which buying your own instruments is rarely worthwhile.

Legal basis and rules

The EU GMP Guide expressly allows testing in an external laboratory, but requires the contract giver to remain in control. In German law, the same principles are set out in the German Ordinance on the Manufacture of Medicinal Products and Active Substances (Arzneimittel- und Wirkstoffherstellungsverordnung, AMWHV) and in the German Medicines Act (Arzneimittelgesetz, AMG).

EU GMP Guide, Chapter 6

Quality control: external laboratories are permitted for particular reasons, and this must be stated in the quality control records. Methods must be validated, and a laboratory using a method it did not validate itself must verify its suitability.

EU GMP Guide, Chapter 7

Outsourced activities: written contract, assessment of the laboratory’s suitability before the work is awarded, a right to audit and no subcontracting without approval.

Section 9 AMWHV

Written contract with clearly defined responsibilities. The contract giver checks whether the contract acceptor works according to the requirements and holds an authorisation where one is required.

Section 13(1) AMG

The authorisation requirement for manufacturing applies accordingly to testing on the basis of which the release of the medicinal product is declared. Section 14(4) is expressly left unaffected.

Section 14(4) AMG

Testing may be carried out at contracted sites if suitable premises and equipment are available there, testing follows the state of the art in science and technology, and the Qualified Person can fulfil their responsibility.

Section 55 AMG and Ph. Eur.

The pharmacopoeia contains the recognised pharmaceutical rules on the quality and testing of medicinal products and their substances.

EU GMP Guide, Annex 16

Certification by the Qualified Person, including the testing of imported batches in the EU.

Chapter 6 also sets the requirements for day-to-day laboratory work. Out-of-specification results and atypical trends must be investigated according to a defined procedure, raw data such as laboratory notebooks must be retained and kept available, and the official pharmacopoeial standards should be used as primary reference standards where they exist. Chapter 7 makes clear that a contract laboratory can also be inspected by the authorities and that the contract must give the contract giver a right to audit. Under German law, Section 64(1) AMG also places sites where medicinal products are only tested under the supervision of the competent authority of the federal state (Land).

How the collaboration works

For ongoing release testing, most of the effort comes at the start. Once methods have been transferred and the contract has been signed, testing becomes routine.

Enquiry and specification

You provide the specification, the test procedures from the marketing authorisation and the expected number of samples. The laboratory checks which methods it already masters and which instruments are needed.

Contract and allocation of responsibilities

A quality agreement sets out who takes samples, who performs which test, how deviations are reported and who retains which data.

Method transfer

Methods from the marketing authorisation are transferred according to a protocol, and pharmacopoeial methods are verified in the laboratory for their suitability for your product.

Sampling and shipment

Samples must be representative of the batch and be transported in a way that keeps the result valid for the batch.

Testing and report

The laboratory tests, evaluates and delivers a test report or a certificate of analysis. On this basis, your Qualified Person decides on certification.

Important

Responsibility for batch certification remains with your Qualified Person, even if every single test is performed externally. Make sure that the QP has access to raw data, investigation reports and the audit reports on the laboratory.

What to look for when choosing a laboratory

Most laboratories master the common techniques. Differences show in their GMP organisation, in how they handle deviations and in how quickly results are available.

Questions to ask the provider

Does the laboratory work under GMP, and is there a current GMP certificate that can be checked in the EU database EudraGMDP?

Does the laboratory hold an authorisation from the authority, if one is required for your testing?

Does it master the methods from your marketing authorisation, and which instruments are available for them?

How is an out-of-specification investigation conducted, and when will you be informed?

Does the laboratory subcontract parts of the testing, and to whom?

How are data integrity and the audit trail secured in the laboratory systems, and how long are raw data retained?

What turnaround times apply to routine samples and to urgent orders?

Are you allowed to audit the laboratory, and when was the last inspection by the authority?

Frequently asked questions

Can I rely on the certificate of analysis from my active substance supplier? +

Partly. Under Chapter 5 of the EU GMP Guide, you may rely on results from the approved manufacturer, but you must at least test the identity of each batch yourself. Relying on the supplier’s results must be justified, and the sites that test and take samples should be audited at risk-based intervals.

Does a pharmacopoeial method have to be revalidated in the laboratory? +

Usually not in full. Chapter 6 requires a laboratory that did not validate a method itself to verify its suitability. For pharmacopoeial methods, this usually means demonstrating that the method works with your product and your matrix.

Who certifies the batch, the laboratory or us? +

Certification always lies with the Qualified Person of the manufacturer or importer. The laboratory delivers the results; it does not certify the batch.

Does a contract laboratory need its own manufacturing authorisation? +

Not necessarily. Under Section 13(1) AMG, testing on the basis of which a medicinal product is released does require an authorisation. However, the same provision leaves Section 14(4) AMG unaffected, under which testing may take place at contracted sites. A laboratory can therefore either hold its own authorisation for testing or work as a contracted site under the contract giver’s authorisation, in which case the contract giver lists it, with the scope of testing, in its application for the authorisation. Which route applies should be clarified before the work is awarded and recorded in the contract.

Can the laboratory perform the testing of imported products? +

Yes, provided the testing takes place in an EU Member State and covers all tests required by the marketing authorisation. The samples must be fully representative of the batch. Under Annex 16, they may also be taken at the manufacturing site in the third country if this is technically justified and backed by formal risk management. Whether a mutual recognition agreement replaces the testing depends on the country of origin and should be clarified in advance.

Sources

Every statement in this text was checked against these primary sources (as of 10.11.2026). Laws, guidelines and authority websites, no advertising.

Providers

Filter by federal state and type →

Company	Location	EvidenceQuote from the company’s website (German)	Credentials
A&O Pharma GmbH A&O Pharma GmbH, based in Efringen-Kirchen with sites in Itzehoe and Lörrach, provides service support to pharmaceutical companies, including batch certification by Qualified Persons, regulatory affairs, GMP consulting and GMP-certified analytics.	Efringen-Kirchen	Evidenced „GMP-konforme Analytik Ihrer Fertigwaren, Stabilitätsproben und Rohstoffe in allen gängigen Darreichungsformen“ Source · 10 Nov 2026 ↗	Manufacturing authorisation GMP certificate
AGON Pharma GmbH AGON Pharma GmbH, based in Wendlingen, provides contract analytical services for batch release testing, stability studies in climatic chambers, and method validation and marketing authorisation support for medicinal products of other companies.	Wendlingen Am Neckar Baden-Württemberg	Evidenced „conduct release testing of your medicinal products for final batch release or quality control on your behalf“ Source · 10 Nov 2026 ↗	Manufacturing authorisation GMP certificate
Aescuven Pharma Deutschland GmbH & Co. KG Aescuven Pharma Deutschland in Baden-Baden manufactures herbal medicinal products on a contract manufacturing basis and offers contract analytical testing according to the European Pharmacopoeia. The site is part of the Shenzhen Xingyin Group.	Baden-Baden Baden-Württemberg	Evidenced „Wir bieten umfassende physikalisch-chemische Auftragsanalytik gemäß den Anforderungen des Europäischen Arzneibuchs (Ph. Eur.) für Wirk- und Hilfsstoffe sowie Arzneiformen.“ Source · 10 Nov 2026 ↗	Manufacturing authorisation GMP certificate
Alpha Pharma-Service GmbH Alpha Pharma-Service GmbH, based in Heilbronn, offers contract analytical testing and analytical methods for pharmaceutical products. The company also rents out climate chambers for the monitored storage of samples.	Heilbronn Baden-Württemberg	Evidenced „Auftragsanalytik unter pharmazeutisch wissenschaftlichen und kundenspezifischen Gesichtspunkten“ Source · 10 Nov 2026 ↗	Manufacturing authorisation GMP certificate
Amcapharm Pharmaceutical GmbH AMCAPHARM Pharmaceutical GmbH, based in Rosbach, manufactures suppositories and liquids on a contract basis, packages and labels them, and provides analytical testing, stability studies and method validation for its clients.	Rosbach Hessen	Evidenced „Dazu zählt auf Wunsch die Beschaffung sämtlicher Ausgangsmaterialien genauso wie das Konfektionieren oder die Analytik im eigenen Labor sowie On-going Stability“ Source · 10 Nov 2026 ↗	Manufacturing authorisation GMP certificate
Artesan Pharma GmbH & Co. KG	Lüchow (wendland) Niedersachsen	Evidenced „Unser Labor verfügt über modernste Technologien. Spezialisten analysieren und bewerten hier Ihr Produkt.“ Source · 10 Nov 2026 ↗	Manufacturing authorisation GMP certificate
Ayna Analytics GmbH Ayna Analytics GmbH, based in Kleinmachnow, operates a testing laboratory that analyses medicinal products non-destructively by near-infrared spectroscopy for pharmacies and pharmaceutical companies. The laboratory also carries out stability studies and batch certification.	Kleinmachnow Brandenburg	Evidenced „Durchführung von regulatorisch konformen, validierten Analysenverfahren von Arzneistoffen u.a. Betäubungsmittel und Zytostatika“ Source · 10 Nov 2026 ↗	Manufacturing authorisation GMP certificate
BBT Biotech GmbH	Baesweiler Nordrhein-Westfalen	Evidenced „verschiedene Dienstleistungen als Gesamtpaket oder einzelne Module an: Auftragsfertigung, die Durchführung von Auftragsanalytik als Ihr Vertragslabor“ Source · 10 Nov 2026 ↗	Manufacturing authorisation GMP certificate
Bioassay Bioassay GmbH, based in Heidelberg, is a bioanalytical contract research organisation providing potency and safety testing of biologics, as well as HPLC analyses, under GMP and GLP conditions.	Heidelberg	Evidenced „We use state of the art, highly sensitive HPLC equipment to conduct qualitative and quantitative analysis under both GMP and non-GMP conditions.“ Source · 10 Nov 2026 ↗
Biochem Labor Für Biologische Und Chemische Analytik GmbH	Karlsruhe Baden-Württemberg	Evidenced „Als GMP-zertifiziertes Labor bieten wir chemisch-physikalische Auftragsanalytik für unsere Kunden aus der pharmazeutischen, chemischen, medizinischen, diagnostischen und kosmetischen Industrie an.“ Source · 10 Nov 2026 ↗	Manufacturing authorisation GMP certificate
Canify AG Canify AG (Leipheim) produces medical cannabis in a former NATO bunker under GMP and GACP and offers contract manufacturing, laboratory analytics and batch certification for partners. The company also distributes its own products.	Leipheim Bayern	Evidenced „supplier qualification, laboratory analysis and stability testing, import, GMP processing, batch release, warehousing and distribution.“ Source · 10 Nov 2026 ↗	Manufacturing authorisation GMP certificate
Chemcon GmbH Chemcon GmbH, based in Freiburg im Breisgau, manufactures active pharmaceutical ingredients and fine chemicals under GMP on a contract basis, in small to medium quantities. The company also offers analytical services for quality control and batch certification.	Freiburg Im Breisgau Baden-Württemberg	Evidenced „ChemCon’s analytics team takes care of your inquiries if you are looking for ICH-compliant quality control, GMP validation, release analysis“ Source · 10 Nov 2026 ↗	Manufacturing authorisation GMP certificate
Demecan GmbH DEMECAN GmbH, based in Ebersbach, cultivates medical cannabis, processes it into its own products and also offers identity and content testing as an analytical service for third parties.	Ebersbach Sachsen	Evidenced „Darüber hinaus bieten wir Identitäts- und Gehaltsprüfungen auch als Dienstleistung an.“ Source · 10 Nov 2026 ↗	Manufacturing authorisation GMP certificate
Eurozyto GmbH Eurozyto GmbH in Königstein im Taunus manufactures patient-specific infusion solutions for pharmacies and tests parenteral nutrition preparations in its own GMP analytical laboratory.	Bad Nenndorf Niedersachsen	Evidenced „Unser Analytik-Labor ist spezialisiert auf die Testungen von parenteraler Ernährung nach den strengen Anforderungen des europäischen und amerikanischen Arzneibuchs und dem GMP-Leitfaden.“ Source · 10 Nov 2026 ↗	Manufacturing authorisation GMP certificate
Ever Pharma Jena GmbH EVER Pharma Jena GmbH in Jena is a production site of the EVER Group for sterile injectable solutions. It carries out contract manufacturing and packaging of medicinal products, and offers analytical testing and stability studies.	Jena Thüringen	Evidenced „We offer GMP analytical testing, simplifying your supply chain and accelerating your timelines.“ Source · 10 Nov 2026 ↗	Manufacturing authorisation GMP certificate
Flavine Europe GmbH Flavine Europe GmbH, based in München, brokers active pharmaceutical ingredients and finished medicinal products and offers laboratory testing in Marseille, regulatory support for manufacturers' dossiers, and logistics with cGMP-compliant warehousing.	München Bayern	Evidenced „Analytical and physical testing of finished products and raw materials“ Source · 10 Nov 2026 ↗	Manufacturing authorisation GMP certificate
GIANT Labs GIANT labs GmbH, based in Berlin, operates a certified contract laboratory for chemical particle analysis, working to principles aligned with GMP and GLP. The company also manufactures and sells analytical instruments and provides maintenance and qualification services.	Berlin	Evidenced „In unserem zertifizierten Auftragslabor analysieren wir die eingereichten Proben nach Inhaltsstoffen und Fremdpartikeln organischer, anorganischer und metallischer Natur qualitativ und quantitativ“ Source · 10 Nov 2026 ↗
Gehrlicher Pharmazeutische Extrakte GmbH Gehrlicher Pharmazeutische Extrakte GmbH in Eurasburg manufactures plant extracts and tinctures in accordance with GMP and produces ointments, creams and liquids on a contract manufacturing basis for clients. Purity testing is available on request.	Eurasburg Bayern	Evidenced „Gründliche Tests zur Identifizierung und Quantifizierung möglicher Verunreinigungen wie Aflatoxine, Schwermetalle, Pestizide, Herbizide und Pyrrolizidinalkaloide“ Source · 10 Nov 2026 ↗	Manufacturing authorisation GMP certificate
ICON Clinical Research Germany GmbH ICON Clinical Research Germany GmbH, based in Langen, is a contract research organisation for clinical trials, with a focus on trial planning, monitoring and data management. According to its website, the portfolio also includes bioanalysis and central laboratories.	Langen	Evidenced „ICON’s Manufacturing & Pharmacy Services offer a seamless, end-to-end approach to formulation development and optimisation for both small molecules and biologics.“ Source · 10 Nov 2026 ↗
Labor Dr. Spranger Labor Dr. Spranger in Ingolstadt is an accredited laboratory that, alongside routine diagnostic testing for physicians, also undertakes analytical commissions for the pharmaceutical industry, including GMP quality control and central laboratory services for clinical trials.	Ingolstadt	Evidenced „Qualitätskontrolluntersuchungen im Rahmen der Herstellung von Arzneimittel nach GMP durch“ Source · 10 Nov 2026 ↗	GMP certificate
Labor Ls SE & Co. KG Labor LS in Bad Bocklet-Großenbrach performs microbiological and physicochemical testing of finished pharmaceutical products on a contract basis, as well as testing of raw materials, excipients and active pharmaceutical ingredients to CGMP standards.	Bad Bocklet Bayern	Evidenced „Darüber hinaus prüft Labor LS zahlreiche Roh-, Hilfs- und Wirkstoffe, In-Prozess-Kontrollen sowie Reinstmedien.“ Source · 10 Nov 2026 ↗	Manufacturing authorisation GMP certificate
Labor Ls SE & Co. KG Labor LS in Bad Bocklet-Großenbrach performs microbiological and physicochemical testing of finished pharmaceutical products on a contract basis, as well as testing of raw materials, excipients and active pharmaceutical ingredients to CGMP standards.	Bad Bocklet-Großenbrach	Evidenced „Darüber hinaus prüft Labor LS zahlreiche Roh-, Hilfs- und Wirkstoffe, In-Prozess-Kontrollen sowie Reinstmedien“ Source · 10 Nov 2026 ↗	Manufacturing authorisation GMP certificate
Lindopharm GmbH Lindopharm GmbH in Hilden manufactures solid oral dosage forms on a contract basis, including hormone tablets and sachets containing granules or powder, and offers laboratory analysis and stability testing for third parties.	Hilden Nordrhein-Westfalen	Evidenced „In addition to carrying out routine and industry-standard quality tests“ Source · 10 Nov 2026 ↗	Manufacturing authorisation GMP certificate
Med Pharma Service GmbH Med Pharma Service GmbH, based in Berlin-Neukölln, is a medium-sized contract manufacturer holding a manufacturing licence under §13 AMG. The company produces capsules, powders and blends on a contract basis and offers analytical services, including sampling and microbiological testing.	Neukoelln Berlin	Evidenced „als zuverlässiger Dienstleister für Auftragsanalytik“ Source · 10 Nov 2026 ↗	Manufacturing authorisation GMP certificate
MyBiotech GmbH MyBiotech GmbH in Ueberherrn is a nanomedicine CDMO that develops nanoparticle formulations, manufactures them under sterile conditions, and provides quality testing and stability studies for its clients.	Ueberherrn Saarland	Evidenced „MyBiotech provide quality control testing with a strong focus on the physico-chemical characterisation of nanoformulations to support batch release and stability studies.“ Source · 10 Nov 2026 ↗	Manufacturing authorisation GMP certificate
Nuvisan GmbH Nuvisan GmbH, based in Neu-Ulm, is a contract research organisation (CRO) with laboratories in Germany and France. It conducts clinical trials and recruits trial participants at its own clinical research sites.	Neu-Ulm Bayern	Evidenced „Our analytical services for small and large molecules include method development, validation, quality control, stability studies, EU re-testing and commercial release.“ Source · 10 Nov 2026 ↗	Manufacturing authorisation GMP certificate
Pensatech Pharma GmbH Pensatech Pharma in Berlin is a contract research partner for dosage forms. The company offers formulation development, analytical services, GMP quality control and stability studies to other pharmaceutical companies.	Adlershof Berlin	Evidenced „Conventional and sophisticated testing equipment is available for QC testing of drug products by compendial, non-compendial, in-house and customer-supplied methods.“ Source · 10 Nov 2026 ↗	Manufacturing authorisation GMP certificate
Pharma Aldenhoven GmbH & Co.KG	Aldenhoven Nordrhein-Westfalen	Evidenced „Wunschgemäß setzen wir Ihre Vorgaben um und führen alle erforderlichen mikrobiologischen und analytischen Prüfungen durch.“ Source · 10 Nov 2026 ↗	Manufacturing authorisation GMP certificate
Pharma-Zentrale GmbH Pharma-Zentrale GmbH in Herdecke is a family-owned group offering GMP-compliant contract manufacturing, fermentation and active pharmaceutical ingredient production, as well as its own probiotic and herbal medicinal products.	Herdecke Nordrhein-Westfalen	Evidenced „Mikrobiologische und chemische Prüfungen, Qualitätsnachweise und dokumentierte Ergebnisse.“ Source · 10 Nov 2026 ↗	Manufacturing authorisation GMP certificate
Phytolab GmbH & Co. KG PhytoLab GmbH & Co. KG in Vestenbergsgreuth is an accredited testing laboratory for herbal medicinal products, foodstuffs and animal feed, with a focus on quality control, trace analysis and reference substances.	Vestenbergsgreuth Bayern	Evidenced „Qualitätskontrolle: Unsere Spezialisten untersuchen Ihre Proben nach dem neuesten Stand der Technik gemäß Arzneibuchmonographien“ Source · 10 Nov 2026 ↗	Manufacturing authorisation GMP certificate
QMEDIS Analytics GmbH QMEDIS Analytics GmbH, based in Potsdam, is a GMP-certified contract laboratory for analytical testing, stability studies and pharmaceutical formulation development, with a focus on cannabis and narcotic substance testing.	Potsdam Brandenburg	Evidenced „Als GMP-zertifiziertes Auftragslabor bietet die QMEDIS Analytics GmbH alle Voraussetzungen, um dem stetig wachsenden Qualitätsanspruch im Arzneimittel-Sektor gerecht zu werden.“ Source · 10 Nov 2026 ↗	Manufacturing authorisation GMP certificate
Rentschler Biopharma SE Rentschler Biopharma SE in Laupheim is a CDMO for biopharmaceuticals, with a focus on process development, cGMP manufacture of recombinant proteins and analytical development for customers worldwide.	Laupheim Baden-Württemberg	Evidenced „Als Full-Service Anbieter für analytische Testung bieten wir Ihnen folgende Services: umfangreiches Monitoring aller Parameter für die Qualitätskontrolle, die analytische Charakterisierung“ Source · 10 Nov 2026 ↗	Manufacturing authorisation GMP certificate
Rottendorf Pharma GmbH Rottendorf Pharma GmbH, based in Ennigerloh, is a contract manufacturer of solid oral dosage forms. It produces batches of 2 to 750 kg, packages them, and provides stability and analytical services to its customers.	Ennigerloh Nordrhein-Westfalen	Evidenced „To meet your outsourcing requirements, we have a modern control laboratory with highly qualified experts who take care of all analytical tasks for your products.“ Source · 10 Nov 2026 ↗	Manufacturing authorisation GMP certificate
RubiePharm Arzneimittel GmbH RubiePharm Arzneimittel GmbH, based in Steinau an der Straße, carries out contract manufacturing of suppositories, ovules, ointments, creams and gels, as well as food supplements. Its services include packaging, material sourcing and stability programmes.	Steinau Hessen	Evidenced „Analytische Prüfungen aller Rohstoffe und Fertigprodukte“ Source · 10 Nov 2026 ↗	Manufacturing authorisation GMP certificate
Tentamus Pharma & Med Deutschland GmbH	Oldenburg Niedersachsen	Evidenced „Wir prüfen Ausgangsstoffe, In-Prozess-Produkte, Wirkstoffe und Fertigarzneimittel mit moderner Laborausstattung und validierten Methoden – gemäß Arzneibuchmethoden oder nach individuellen Vorgaben.“ Source · 10 Nov 2026 ↗	Manufacturing authorisation GMP certificate
Wiewelhove GmbH Wiewelhove GmbH in Ibbenbüren is a contract manufacturer of solid dosage forms such as tablets, capsules and coated tablets. Its services include packaging, in-house analytical testing, and validation and project management.	Ibbenbueren Nordrhein-Westfalen	Evidenced „In diesem Labor führen wir die Rohstoffanalytik und die Fertigwarenanalytik aus.“ Source · 10 Nov 2026 ↗	Manufacturing authorisation GMP certificate
nuvalore GmbH nuvalore GmbH, based in Leimen, provides analytical services for the pharmaceutical industry, including method development and validation, stability and release testing, and consultancy on Quality by Design.	Leimen Baden-Württemberg	Evidenced „Routinemäßige Arzneibuchprüfungen – ph-Wert, Osmolarität, Klarheit, nicht sichtbare Partikel und entnehmbares Volumen“ Source · 10 Nov 2026 ↗	Manufacturing authorisation GMP certificate

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