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Contract manufacturing of liquids and semi-solids

Solutions, syrups, creams and ointments manufactured and filled to order.

Partners for Contract manufacturing of liquids and semi-solids

Paid placements · labelled

In brief

Liquid dosage forms include solutions, syrups, suspensions and emulsions for oral or external use, and semi-solid forms are mainly creams, ointments and gels. They are manufactured by dissolving, dispersing, emulsifying and homogenising in mixing vessels and are then filled into bottles, tubes or other containers. Because these products contain water or are exposed to the environment during manufacture, their microbiological quality is the central issue.

In contract manufacturing, a contract manufacturer takes over compounding, filling and often also packaging for the owner of the product. The obligations of both parties are set out in a written contract, and the contract giver remains responsible for controlling the outsourced manufacturing. This text covers non-sterile products. Sterile preparations are additionally subject to the rules for sterile medicinal products.

Who needs this
Companies without their own compounding and filling equipment for liquids or semi-solid preparations, or without a suitable format and free capacity.
Legal basis
Manufacturing authorisation under Section 13 of the German Medicines Act (AMG), the German Ordinance on the Manufacture of Medicinal Products and Active Substances (AMWHV) and the EU GMP Guide with Annex 9 for liquids, creams and ointments.
Typical scope
Compounding and homogenising, filling into bottles, tubes or dispensers, in-process controls and, on request, packaging.
What matters
Clean water systems, equipment that is easy to clean, assured homogeneity during filling and clear hold times.

When you need this

Liquid and semi-solid forms require their own equipment: mixing vessels with stirring and homogenising technology, a supply of water of pharmaceutical quality and filling machines for the respective container. For companies with only a few products of this kind, this is rarely worthwhile. Contract manufacturing is therefore typical for companies that market a product without manufacturing it themselves, for manufacturers that lack a particular format, for example tubes or pump dispensers, and for development projects that need clinical trial material in small quantities.

A change of packaging can also make a new manufacturer necessary, because the container and closure directly affect the shelf life and use of a liquid or semi-solid product.

Legal basis and rules

Like any manufacture of medicinal products, this one requires a manufacturing authorisation under Section 13 AMG, which under Section 16 AMG is granted for a site and for specific dosage forms. The AMWHV obliges the site to follow Good Manufacturing Practice in line with the EU GMP Guide. The Guide contains a separate annex for this product group.

Sections 13 and 16 AMG
Manufacturing authorisation from the competent Land authority (Länder) for a site and for specific medicinal products and dosage forms.
Sections 3 and 9 AMWHV
Good Manufacturing Practice in line with the EU GMP Guide and a written contract for every activity carried out on behalf of another party.
EU GMP Guide, Annex 9
Manufacture of liquids, creams and ointments: closed systems, cleanable equipment, water quality, homogeneity and hold times.
EU GMP Guide, Annex 15
Qualification of equipment and utility systems such as water and air, process validation and cleaning validation.
European Pharmacopoeia 5.1.4
Requirements for the microbiological quality of non-sterile preparations, graded by route of administration.
European Pharmacopoeia 5.1.3
Test for efficacy of antimicrobial preservation where a product contains a preservative. Under the EMA guideline on preservatives, it is also tested at the end of shelf life and, for multi-dose containers, under simulated conditions of use.

What Annex 9 requires

Annex 9 assumes that liquids, creams and ointments are particularly susceptible to microbial and other contamination during manufacture. It therefore recommends closed systems for processing and transfer and requires that areas where products or open clean containers are exposed should normally be effectively ventilated with filtered air. Tanks, pipework and pumps should be easy to clean and, where necessary, to sanitise, and should have as few dead legs as possible where residues can accumulate and microorganisms can grow. Glass apparatus should be avoided where possible, and high-quality stainless steel is often the material of choice for product-contact parts.

The chemical and microbiological quality of the water must be specified and monitored, and a validated flushing procedure is needed after chemical sanitisation of the water system. Materials that shed fibres, such as cardboard or wooden pallets, do not belong in areas where product is exposed. When filling mixtures and suspensions, homogeneity must be maintained, especially at the start of filling, after interruptions and at the end of filling. Mixing and filling processes must be validated. If the product is not filled immediately, the maximum permitted storage time and the storage conditions must be specified and observed.

Important
Hold times between compounding and filling are not a minor detail. Clarify how the manufacturer supports them for your product and what happens when filling is interrupted.

How the collaboration works

The collaboration is governed by Chapter 7 of the EU GMP Guide. The contract giver first assesses the suitability of the contract acceptor and then monitors its performance on an ongoing basis. The path to routine supply usually looks like this:

01
Describe the requirements
Dosage form, viscosity, preservation, container and closure, fill volumes, batch sizes and annual demand. For suspensions and emulsions, this also includes their behaviour on standing.
02
Audit and selection
The audit focuses on the water system, cleaning and sanitisation of the equipment, environmental conditions in the filling area and the results of microbiological controls.
03
Quality agreement
It covers sourcing and release of starting materials and packaging materials, the division of testing, the handling of deviations and changes and the certification of batches by the agreed Qualified Person (QP).
04
Technology transfer
Formulation, compounding instructions, process parameters and test methods are handed over, and stirring and homogenising conditions are adapted to the manufacturer’s equipment and supported with validation batches.
05
Routine manufacturing
The manufacturer compounds, fills and tests, and the QP certifies. Changes to equipment, raw materials or container relevant to the marketing authorisation are agreed in advance.

What to look for when selecting a manufacturer

The following questions help to make offers comparable and to follow up during the audit.

Questions to ask the provider
Does the manufacturing authorisation cover liquid and semi-solid forms of your type, and when was the last inspection?
How is the water system designed, and how are its quality and sanitisation monitored?
Does the equipment operate as a closed system, and how is it cleaned and sanitised?
Which batch sizes, viscosities and containers can the manufacturer process?
How is homogeneity assured when filling suspensions and emulsions?
Which hold times are validated, and how are interruptions handled?
Are microbiological tests and preservative efficacy tests performed in-house?
Is there experience with products containing hormones or other critical active substances, if your product is one of them?

Frequently asked questions

Does Annex 1 also apply to non-sterile liquids? +
No. Annex 1 governs the manufacture of sterile medicinal products. For non-sterile liquids, creams and ointments, Annex 9 is the specific part of the EU GMP Guide, supplemented by the general chapters and Annex 15. If a product is to be sterile, the requirements of Annex 1 apply.
Which microbiological limits apply? +
In chapter 5.1.4, the European Pharmacopoeia sets requirements for the microbiological quality of non-sterile preparations, graded by route of administration. Which values apply to your product follows from the marketing authorisation and the specification.
Who is responsible for the quality of the product? +
The contract manufacturer is responsible for Good Manufacturing Practice at its site. Under Chapter 7, the contract giver remains responsible for controlling the outsourced manufacturing. The details are set out in the quality agreement.
Can a product do without a preservative? +
This is a question of development, not of the manufacturer alone. If a product contains a preservative, its efficacy is tested according to the Pharmacopoeia. If it does not, development must show that the microbiological quality is maintained over the shelf life and, where applicable, during use. Discuss early with the manufacturer what this means for filling and container.

Sources

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

  1. EU-Kommission (EudraLex) · 3db7d485-61e2-4f61-a16a-82a6dbf0e914_en
  2. Gesetze im Internet · __13.html
  3. Gesetze im Internet · __16.html
  4. Gesetze im Internet · __3.html
  5. Gesetze im Internet · __9.html
  6. EU-Kommission (EudraLex) · eudralex-volume-4_en
  7. EU-Kommission (EudraLex) · 2015-10_annex15_0.pdf
  8. EMA · ich-q-4-b-annex-4c-note-evaluation-and-recommendation-pharm…
  9. dmp.no · mikrobiologisk-kvalitet-av-legemilder
  10. EU-Kommission (EudraLex) · 20220825_gmp-an1_en_0.pdf
  11. EU-Kommission (EudraLex) · vol4-chap7_2012-06_en_0.pdf
  12. EDQM (Ph. Eur.) · pharmeuropa-38.3-just-released
  13. EMA · guideline-excipients-dossier-application-marketing-authoris…
  14. EMA · note-guidance-inclusion-antioxidants-and-antimicrobial-pres…
CompanyLocationEvidenceQuote from the company’s website (German)Credentials
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

„Lohnherstellung von Liquida Bei der Lohnherstellung von Liquida haben wir uns besonders auf die Herstellung von kleinen und mittleren Chargengrößen spezialisiert.“

Source · 10 Nov 2026 ↗
Manufacturing authorisation GMP certificate
Dronania Pharmaceuticals GmbH

DRONANIA pharmaceuticals GmbH in Bad Wörishofen provides contract manufacturing of herbal preparations, including tablets, capsules and liquids, along with blister packing and bottle filling.

Bad Woerishofen
Bayern
Evidenced

„Wir produzieren Flüssigkeiten für vielfältige innerliche und äußerliche Applikationen. Zwei Produktionslinien zur Abfüllung und Konfektionierung.“

Source · 10 Nov 2026 ↗
Manufacturing authorisation GMP certificate
Dyckerhoff Pharma GmbH & Co. KG

Köln
Nordrhein-Westfalen
Evidenced

„Wir bieten eine GMP-gerechte Lohnherstellung für Arzneimittel an und sind spezialisiert auf die Lohnherstellung kleiner Chargen von flüssigen Formen in Glasampullen.“

Source · 10 Nov 2026 ↗
Manufacturing authorisation GMP certificate
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

„Wir besitzen einen großen Erfahrungsschatz in der Produktion von Fertigarzneimitteln wie Salben, Cremes und Liquida.“

Source · 10 Nov 2026 ↗
Manufacturing authorisation GMP certificate
Igs Aerosols GmbH

IGS Aerosols GmbH in Wehr (Baden) is a contract filler of aerosol products, with a focus on pharmaceuticals and chemical-technical products. The company manufactures private-label products for customers and offers filling into aerosol cans.

Wehr
Baden-Württemberg
Evidenced

„Wir fertigen ausschließlich und unabhängig Private-Label Produkte. Dabei setzen wir hochprofessionell Ihre Wünsche und Anforderungen um.“

Source · 10 Nov 2026 ↗
Manufacturing authorisation GMP certificate
Kraeber & Co. GmbH

Kraeber & Co GmbH, based in Ellerbek near Hamburg, is a family-owned company that sells active pharmaceutical ingredients and, through its Bioscience division, manufactures substances from animal and plant-based raw materials. Contract manufacturing is offered as a service.

Ellerbek
Schleswig-Holstein
Evidenced

„We develop tailor-made solutions for your requirements as your competent and reliable partner for contract manufacturing.“

Source · 10 Nov 2026 ↗
Manufacturing authorisation GMP certificate
Leyh Pharma GmbH

Leyh-Pharma GmbH, based in Brotterode-Trusetal in the Thuringian Forest, manufactures medicinal products, cosmetics and medical devices, and offers contract manufacturing of liquid and semi-solid forms as well as filling services.

Brotterode-Trusetal
Thüringen
Evidenced

„Herstellungserlaubnis nach § 13 AMG für nichtsterile Humanarzneimittel flüssiger und halbfester Dareichungsformen“

Source · 10 Nov 2026 ↗
Manufacturing authorisation
Lichtenheldt GmbH Pharmazeutische Fabrik

Lichtenheldt GmbH in Wahlstedt is a contract manufacturer of liquid and semi-solid medicinal products, offering filling and serialisation on a contract basis. It also produces cosmetics and food supplements.

Wahlstedt
Schleswig-Holstein
Evidenced

„Wir liefern Ihre flüssigen Produkte wie Lösungen, Tropfen und Sirup in Glasflaschen, Kunststoffflaschen oder Kanistern.“

Source · 10 Nov 2026 ↗
Manufacturing authorisation GMP certificate
MPA Pharma GmbH

MPA Pharma GmbH, based in Osterburg and Trittau, operates in re-importation and parallel import of EU-authorised medicinal products and provides contract manufacturing for third-party companies, including repackaging, folding carton and label production. The company applies the same regulatory standards expected of GMP-compliant operations under EU law.

Osterburg
Sachsen-Anhalt
Evidenced

„Lohnfertigung im Bereich der Konfektionierung von Arzneimitteln, der Herstellung von spezifizierten Faltschachteln sowie individuellen Etiketten und Beipackzetteln“

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

„Herstellung von Mischungen und Kapselprodukten“

Source · 10 Nov 2026 ↗
Manufacturing authorisation GMP certificate
NUTRICHEM DIAET + PHARMA GmbH

NUTRICHEM DIÄT + PHARMA GmbH in Roth develops, manufactures and packages nutritional and pharmaceutical products, predominantly enteral nutrition and sports nutrition. The company offers contract manufacturing, filling and logistics services for its customers.

Roth
Bayern
Evidenced

„NUTRICHEM DIÄT + PHARMA GMBH entwickelt, produziert und verpackt hochwertige Ernährungs- und Pharmaprodukte mit modernster Technologie für Kunden in aller Welt.“

Source · 10 Nov 2026 ↗
Manufacturing authorisation GMP certificate
PRISMAN GmbH

PRISMAN GmbH in Lorsch manufactures liquid and paste-form products under GMP as contract manufacturing for customers, and provides packaging to customers' specifications. The company also develops its own specialty products.

Lorsch
Hessen
Evidenced

„Auf Kundenwunsch produzieren wir auf ca. 12.000 qm Betriebsfläche nach eigens entwickelten Rezepturen und übernehmen die Konfektionierung der Produkte ausschließlich nach Kundenvorgaben.“

Source · 10 Nov 2026 ↗
Manufacturing authorisation
Pharma Aldenhoven GmbH & Co.KG

Aldenhoven
Nordrhein-Westfalen
Evidenced

„Gerne stellen wir auch für Sie im Rahmen der Lohnabfüllung Produkte nach Ihren eigenen Rezepturen her.“

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

„Herstellung fester und flüssiger Darreichungsformen“

Source · 10 Nov 2026 ↗
Manufacturing authorisation GMP certificate
Rommelag CDMO GmbH

Rommelag CDMO GmbH in Sulzbach-Laufen is a contract manufacturer for liquid and semi-solid pharmaceutical products using the blow-fill-seal process. It also offers process development, packaging development and trial batches.

Sulzbach-Laufen
Baden-Württemberg
Evidenced

„Wir verarbeiten ein breites Spektrum an flüssigen und halbfesten Produkten, darunter Injektions-, Infusions- und Inhalationslösungen sowie Augentropfen“

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

„Effizient ist die Lohnfertigung von RubiePharm auch bei der Herstellung von Salben, Cremes und Gelen.“

Source · 10 Nov 2026 ↗
Manufacturing authorisation GMP certificate
Spreewaelder Arzneimittel GmbH

Maerkische Heide
Brandenburg
Evidenced

„Flüssigkeiten und halbfeste Produkte (Cremes, Salben, Gele) – Kapazität 250 l, 500 l, 1000 l, Mischen, Erhitzen, Wasser- und Fettphasentrennung, Homogenisieren, Abfüllen in Flaschen, Tuben“

Source · 10 Nov 2026 ↗
Manufacturing authorisation GMP certificate
Steierl-Pharma GmbH

Steierl-Pharma GmbH, based in Herrsching am Ammersee, has manufactured its own naturopathic medicinal products since 1949. The company also provides contract manufacturing of liquid preparations for other manufacturers, using automated filling.

Herrsching A.Ammersee
Bayern
Evidenced

„Gerne stellen wir Ihr flüssiges Nahrungsergänzungsmittel, homöopathisches oder pflanzliches Arzneimittel in Chargen von 100 bis 1.000 Liter für Sie her.“

Source · 10 Nov 2026 ↗
Manufacturing authorisation GMP certificate
Synthera Dr. Friedrichs GmbH & Co. KG

Arnsberg
Nordrhein-Westfalen
Evidenced

„Auftragsherstellung flüssiger Homöopathika und Phytopharmaka. Wir bieten Ihnen das Rundum-Sorglos-Paket für Ihre oralen Liquida.“

Source · 10 Nov 2026 ↗
Manufacturing authorisation GMP certificate
Trommsdorff GmbH & Co. KG

Trommsdorff GmbH & Co. KG, based in Alsdorf, is a medium-sized manufacturer of medicinal products and food supplements that also offers contract manufacturing for national and international clients. The company is part of the Dermapharm Group.

Alsdorf
Nordrhein-Westfalen
Evidenced

„Als "Full-Service"-Unternehmen mit umfassender Produktion und Lohnfertigung, Marketing und Vertrieb bieten wir nationalen und internationalen Kunden ein komplettes Leistungsspektrum an.“

Source · 10 Nov 2026 ↗
Manufacturing authorisation GMP certificate
Ursapharm Arzneimittel GmbH

URSAPHARM Arzneimittel GmbH, based in Saarbrücken, is a medium-sized manufacturer of ophthalmic pharmaceuticals that also provides contract manufacturing for third parties alongside its own products.

Saarbruecken
Saarland
Evidenced

„Zudem wurde der Bereich Lohnfertigung als zusätzliches Standbein ausgebaut. In hochmodernen Fertigungsanlagen, die nationalen wie auch internationalen Anforderungen entsprechen, produzieren Spezialisten nach streng validierten Herstellungs- und Prüfverfahren pharmazeutische Produkte für dritte Unternehmen.“

Source · 10 Nov 2026 ↗
Manufacturing authorisation GMP certificate

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