Winhycare Pharma · EU, EEA, UK & Switzerland
Peptide and biosimilar lyophilisation for European companies
Lyophilisation (freeze-drying) and vial filling of peptides and biosimilars for research peptide brands, biotech and pharmaceutical companies in all 32 countries of the EU, EEA, the United Kingdom and Switzerland, processed at WHO-GMP certified manufacturing partners in India.
By Kareem Ahmed Basha, Director & Chief Scientific Officer · Reviewed by Nisar Mohammed · Updated
WHO-GMPCertified manufacturing partners
- Pharmazeutische Lyophilisierung (Gefriertrocknung) und Abfüllung von Peptiden in VialsDeutsch
- Lyophilisation pharmaceutique et remplissage de flacons de peptidesFrançais
- Liofilizzazione farmaceutica e riempimento di flaconi per peptidiItaliano
- Liofilización farmacéutica y llenado de viales de péptidosEspañol
- Farmaceutische lyofilisatie (vriesdrogen) en afvullen van peptiden in flaconsNederlands
- Liofilizacja farmaceutyczna peptydów i napełnianie fiolekPolski
In short
- We lyophilise and fill peptides and biosimilars into vials, from cycle development through engineering, pilot and commercial batches.
- Projects are managed from Hyderabad, India, and processed at WHO-GMP certified manufacturing partners in India, with India-based processing costs.
- Bring your own peptide or biosimilar: lyophilisation and vial filling are offered on their own for material you supply.
- Research-use-only material carries the RUO designation; commercial work on approved products is subject to approvals, licences and site authorisations.
- WHO-GMP certification is not an EU GMP certificate. For EU clinical or commercial supply, the site must meet EU GMP requirements and be named in the application, and each imported batch of an authorised medicine is tested in the EU and certified by a Qualified Person, as there is no EU and India mutual recognition agreement.
The service in under two minutes
Read the transcript
Many peptides and biosimilars are unstable in solution. Lyophilisation solves that. The product is filled into vials and frozen. Under vacuum, the ice turns straight to vapour. Then the remaining bound water is removed. What's left is a stable, dry cake, sealed in the vial and ready to reconstitute. Winhycare Pharma lyophilises and fills peptides and biosimilars into vials, at WHO-GMP certified manufacturing partners in India. We develop the freeze-drying cycle for your formulation. We control freezing and drying, optimise residual moisture and reconstitution, and handle nitrogen flushing, stoppering, crimp sealing and documentation. Already have your peptide? Send it to us, and we'll lyophilise it as a standalone service. Or source the peptide and the lyophilisation together, in one project. Every project starts with a technical scope and cycle development, then moves through engineering and pilot batches, to commercial campaigns for approved products. Research-use-only material carries the right designation, and commercial work follows the applicable approvals. We work with companies across Europe, the United Kingdom and the United States. For a proposal, send us your product details, intended use, quantity per vial, batch size, testing needs and timeline. Winhycare Pharma. Peptide and biosimilar lyophilisation, from cycle to vial.
Who in Europe uses the service
Research peptide brands and distributors
Lyophilisation and vial filling of research peptides, handled with the appropriate Research Use Only (RUO) designation.
Biotech companies
Development work from formulation and cycle development to engineering and pilot batches.
Pharmaceutical companies
Commercial manufacturing of approved products, subject to regulatory approvals, manufacturing licences and site authorisations.
Universities and research institutes
Lyophilised research material for laboratory studies, supplied for research use only.
EU requirements depend on the end use
The same lyophilisation step sits under different rules depending on whether the vials are for laboratory research, a clinical trial or an authorised medicine.
Research use only (RUO)
RUO material is not a medicinal product. It is processed and labelled with the RUO designation and is not for human or veterinary use. Buyers are responsible for national import and use rules.
Clinical trials
Investigational medicinal products must be made under GMP for investigational medicinal products (Delegated Regulation (EU) 2017/1569) and released by a Qualified Person under the Clinical Trials Regulation (EU) No 536/2014.
Authorised medicines
Batches made outside the EU must be tested in the EU and certified by a Qualified Person before release (Article 51 of Directive 2001/83/EC), unless a mutual recognition agreement applies; there is none between the EU and India. The importer needs a manufacturing and import authorisation.
Sterile manufacturing
Lyophilised injectable products fall under EU GMP Part I and Annex 1 (manufacture of sterile medicinal products), which applies to the filling and freeze-drying steps.
United Kingdom and Switzerland: Great Britain applies its own import and QP certification rules through the MHRA, and Switzerland through Swissmedic. We confirm the documentation each project needs with your regulatory team.
Countries we serve and their medicines regulators
All EU member states, the EEA countries (Iceland, Liechtenstein, Norway), the United Kingdom and Switzerland. The authority listed is the national competent authority for medicines, which you will deal with for authorisations and inspections in that country.
| Country | Medicines regulator | Service page |
|---|---|---|
| Austria | BASG (Federal Office for Safety in Health Care) | Deutsch |
| Belgium | FAMHP (Federal Agency for Medicines and Health Products) | Français |
| Bulgaria | BDA (Bulgarian Drug Agency) | English |
| Croatia | HALMED (Agency for Medicinal Products and Medical Devices) | English |
| Cyprus | Pharmaceutical Services, Ministry of Health | English |
| Czechia | SÚKL (State Institute for Drug Control) | English |
| Denmark | Danish Medicines Agency | English |
| Estonia | State Agency of Medicines | English |
| Finland | Fimea (Finnish Medicines Agency) | English |
| France | ANSM (French National Agency for Medicines and Health Products Safety) | Français |
| Germany | BfArM and Paul-Ehrlich-Institut; GMP inspections by the federal states | Deutsch |
| Greece | EOF (National Organisation for Medicines) | English |
| Hungary | NNGYK (National Center for Public Health and Pharmacy) | English |
| Iceland | Icelandic Medicines Agency | English |
| Ireland | HPRA (Health Products Regulatory Authority) | English |
| Italy | AIFA (Italian Medicines Agency) | Italiano |
| Latvia | State Agency of Medicines | English |
| Liechtenstein | Office of Public Health | Deutsch |
| Lithuania | State Medicines Control Agency | English |
| Luxembourg | Division of Pharmacy and Medicines, Ministry of Health | Français |
| Malta | Malta Medicines Authority | English |
| Netherlands | CBG-MEB (Medicines Evaluation Board); GMP inspections by IGJ | Nederlands |
| Norway | Norwegian Medical Products Agency | English |
| Poland | URPL (Office for Registration of Medicinal Products); GMP inspections by GIF | Polski |
| Portugal | INFARMED | English |
| Romania | ANMDMR (National Agency for Medicines and Medical Devices) | English |
| Slovakia | ŠÚKL (State Institute for Drug Control) | English |
| Slovenia | JAZMP (Agency for Medicinal Products and Medical Devices) | English |
| Spain | AEMPS (Spanish Agency of Medicines and Medical Devices) | Español |
| Sweden | Swedish Medical Products Agency | English |
| Switzerland | Swissmedic | Deutsch |
| United Kingdom | MHRA (Medicines and Healthcare products Regulatory Agency) | English |
How a European project runs
- 1Project discussion and technical scope
- 2Formulation and cycle development
- 3Engineering batch
- 4Pilot processing
- 5Commercial campaign (approved products)
Most projects begin with engineering or pilot batches. Lyophilised vials are shipped from India to Europe; the temperature range, packaging and shipping documents are agreed for each project.
Biosimilars and other biologics
Alongside peptides, we lyophilise and fill biosimilars into vials at our WHO-GMP certified manufacturing partners. Protein formulations need a cycle built around lyoprotectants, collapse temperature, residual moisture and aggregation.
Biosimilar and protein lyophilisation →Frequently asked questions
Do you work with companies in every European country?
Yes. We work with companies in all EU and EEA countries, the United Kingdom and Switzerland. Projects are run in English, and the service page is also available in German, French, Italian, Spanish, Dutch and Polish.
Where is the lyophilisation carried out?
Projects are managed by Winhycare Pharma in Hyderabad, India, and processed at WHO-GMP certified manufacturing partners in India.
Can we send our own peptide just for lyophilisation?
Yes. Lyophilisation and vial filling are offered as a standalone service for peptides or biosimilars you supply. You do not need to buy the peptide from us.
Can lyophilised vials be supplied for clinical trials in the EU?
Clinical-trial material must be made under GMP for investigational medicinal products and released by a Qualified Person in the EU. Whether a given project can meet those requirements is assessed with you during the technical scope.
What happens when an approved medicine made in India is imported into the EU?
Each batch is tested in the EU and certified by a Qualified Person before release (Article 51 of Directive 2001/83/EC), because there is no mutual recognition agreement between the EU and India. Commercial projects are assessed one by one against these requirements and the applicable approvals and licences.
Do you lyophilise biosimilars as well as peptides?
Yes. We lyophilise and fill peptides and biosimilars into vials through our manufacturing partner. Commercial processing of approved products is subject to the applicable regulatory approvals, manufacturing licences and site authorisations.
Can research-use-only peptides be lyophilised for European distributors?
Yes. Research peptides are lyophilised and filled with the appropriate RUO designation. They are not for human or veterinary use, and distributors remain responsible for the rules in the countries where they sell.
Sources
- Directive 2001/83/EC (Article 51), EUR-Lex
- Regulation (EU) No 536/2014 on clinical trials, EUR-Lex
- Delegated Regulation (EU) 2017/1569, GMP for investigational medicinal products, EUR-Lex
- EudraLex Volume 4, EU GMP guidelines (Part I and Annex 1), European Commission
- Mutual recognition agreements (MRA), European Medicines Agency
Discuss a lyophilisation project in Europe
Share the product, specifications and regulatory status, intended use, quantity per vial and formulation, batch size and vial configuration, testing and documentation needs, and your target market and timeline. Contact Kareem Ahmed Basha ([email protected]) or [email protected].
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