SERVICES TO THIRD PARTIES
FOR PHARMACEUTICAL COMPANIES, LABORATORIES AND WHOLESALERS
We provide manufacturing services through Farmasierra Manufacturing and distribution services through Farmasierra Distribution to other laboratories and pharmaceutical companies.
- Contract manufacturing
- Pilot batches and industrial scale-up
- Technology transfer
- Preparation of medication for clinical trials
- Associated services
- Order processing
- Transport management
- Reverse logistics
FOR LABORATORIES AND PHARMACEUTICAL COMPANIES
Farmasierra Manufacturing is a company specialised in the manufacturing of medicines, food supplements and health products.
From our pharmaceutical plant in San Sebastián de los Reyes (Madrid) we offer manufacturing services both in the preparation of the product and in the preparation of the medication for clinical trials.
We provide a complete service for the entire production process from the formulation and mixing to the pharmaceutical form, its packaging and conditioning as a finished product.
In manufacturing to third parties, we proceed as follows:
- Quality Agreement
- Purchase of materials
- Order delivery
MANUFACTURING TO THIRD PARTIES
We offer manufacturing services to third parties with high capacity and in various dosage forms.
The solid form manufacturing area has various mixing sections and high capacity for the manufacturing of tablets, coated tablets, hard gelatine capsules, solution powder and powder for extemporaneous solutions.
Packaging: blister packs, bottles, jars and envelopes.
This area consists of two gels sections and two ointments and lotions sections with independent packaging and conditioning areas.
Packaging: aluminium tubes, roll-on containers.
There are two mixing areas and three packaging-conditioning areas with their respective production lines for manufacturing solutions and suspensions.
PILOT BATCH MANUFACTURING AND INDUSTRIAL SCALE-UP
This area is equipped with the following machinery:
- V shaped mixing machines of various sizes.
- High intensity mixing machine.
- Tablet-pressing machines.
- Hard gelatine capsule filling machines.
- Envelope filling machines.
- Blistering machine.
- Bottle filling machine (tablets, powder, capsules).
- Tube filling machines.
- Bottle filling machine (liquids, suspensions, syrups, extemporaneous solutions).
The technology transfer process is carried out in collaboration with the customer, who establishes the technical requirements and quality specifications.
The technician responsible for Technology Transfer at Farmasierra Manufacturing, S.L. defines the activities to be carried out, the tasks of each of the members of the specialised team and the schedule to be followed.
A multidisciplinary team, made up of experts in Galenical Development, Analytical Development, Quality and Engineering and Production, carries out the tests and qualifications required in order to obtain the relevant health authorisations.
PREPARATION OF MEDICATION FOR CLINICAL TRIALS
We are authorised by the Spanish Agency of Medicines and Medical Devices (AEMPS) for the preparation of Medication for Clinical Trials (Investigational Medicinal Products, IMP). We have special areas for the preparation of such medication in solid, semi-solid and liquid forms.
- Preparation of medication for clinical trials in preclinical and clinical phases.
- Design of the Working Protocol together with the client.
- Implementation of the Working Protocol within the established deadlines.
- Sending the medication to the destination points indicated by the client.
- Control of all the activities carried out, documentation and archiving of all the information generated.
We provide our manufacturing customers with the following services related to the products we manufacture for them: Technical feasibility studies and economic evaluation of manufacturing projects, as well as the study of the technologies to be applied and the processes to be carried out.
STUDIES AND VALIDATIONS
Stability studies, validations, technical and economic feasibility studies of technologies, processes and products. Implementation of stability programmes and validations, in accordance with the requirements of the health authorities and the clients.
PURCHASING AND CONTROL OF MATERIALS
Purchase of materials and control of the requirements established by the client through an effective management of the quality, the economic aspects and the supply.
The preparation of documentation for the sanitary registration of products can be carried out in Spanish and/or English, according to the client’s needs.
DISPATCH OF FINISHED PRODUCT
Once the manufactured products are released by the quality control department, they are available to the customer in our warehouses.
Storage of goods until approval and preparation of shipments.
Transport management and compliance with customs requirements, where applicable.
A long-term vision to find solutions for the future
FOR LABORATORIES AND PHARMACEUTICAL COMPANIES
Farmasierra Distribución, S.L. provides storage, order preparation and transport management services for medicines, food supplements and health products to wholesalers, hospitals and pharmacies, as well as reverse logistics services.
We have a Distribution Centre in Cabanillas del Campo, with a high storage capacity, chambers with temperature ranges of 2 to 8ºC and -18 to -22ºC and order preparation, from which we provide service throughout the country.
We have total integration with manufacturers and transporters, which allows us to give an excellent service, reliable and perfectly traceable.
We offer a complete service of product reception and computer communications, storage, order processing and transport management; as well as real-time information on the status of orders, stock, delivery receipts, etc.
We base our work on a study of the needs, calculation of rates, Distribution Contract and its signature, when necessary, as well as the signature of the Quality Agreement and as many documents as required.
Finally, a transfer plan is designed for the products from the Main Laboratory to the Cabanillas del Campo Distribution Centre (Guadalajara).