Manufacturing
Technical and Manufacturing Area
Manufacturing
Meiji Pharma Spain, S.A., located in Alcalá de Henares, operates two fully separate manufacturing plants covering a total of 11,000 m2 within a total site of 56,000 m2. One plant is dedicated exclusively to the production of antibiotics (cephalosporins), while the other is a general plant for non-antibiotics, producing a variety of pharmaceutical forms including tablets, granules, eye drops, syringes, and ampoules. All Meiji products are manufactured to the highest quality standards.
Our products are manufactured and exported from our facilities to more than 25 countries around the world, as a result of which we hold GMP certifications from the world's leading regulatory agencies: EU GMP and ISO 13485 (Europe), US FDA (United States), ANVISA (Brazil), PMDA (Japan), etc.
Antibiotics Plant (Cephalosporins)
This plant is a single product plant, and therefore, all the equipment installed in it are dedicated exclusively to the manufacture of Cefditoren Pivoxil (Cephalosporin) coated tablets in various dosages. It highlights the high quality standards required, both for the manufacture and commercialization of the tablets for the national market, as well as for their export to more than 13 countries (EU, Asia, and America).
General Plant
Oral solids
Weighing
All raw materials are weighed in laminar flow cabinets. Full traceability of products and materials is maintained through computerised control systems.
Granulates / Blends
Various granulation and blending techniques are used, including simple mixing, fluid-bed granulation and drying, or kneading, granulation, and vacuum drying. High-tech equipment is employed, including mixers, kneaders, and fluid beds (Cyclops, Huttlin, Zanchetta, Roto Mix, etc.). All equipment is fully computerised.
Tablets
All equipment uses integrated control systems to ensure correct compression processes and allow automatic parameter correction in case of deviations.
Film-coated tablets
The coating equipment is fully automatic and computerised.
Sachets
To facilitate the administration of certain medicines, particularly those containing iron-protein complexes, there are dedicated dosing and packaging lines for sachets. These lines support both the company’s own brands and production for third-party companies.
Sterile production
The sterile manufacturing area is located within the General Plant but is completely independent. Various sterile pharmaceutical forms are manufactured there.
Ampoules
The manufacturing plant carries out ampoule filling with terminal sterilisation. 100% of the units are inspected.
Pre-filled syringes
Sterile pre-filled syringes (produced via aseptic filling) are manufactured and sold both as medicines and as medical devices. 100% of the units are inspected. We currently ship pre-filled syringes to more than 25 countries across all 5 continents.
Eye drops
A dosing machine is used for the production of sterile eye drops. 100% of the units are inspected.
Packaging
Meiji’s facilities allow for primary packaging to be carried out in classified rooms. These are separate from the secondary packaging area. In the General Plant, there are four blister lines equipped with two serialisation systems (anti-counterfeiting). In the Antibiotics Plant, there is a blister line with an integrated cartoner and packer connected to a serialisation system. All materials are properly identified through a coding system, ensuring full traceability.
Warehouse and Logistics
The warehouse has a capacity of 8,200 pallets. Its management is computerised (SAP ERP) and validated in accordance with 21 CFR Part 11. Order preparation and production orders are also computerised, ensuring full traceability of all medicines and materials from the moment an order is issued until the medicine is dispatched. The warehouse includes a large cold storage area with a capacity of 185 pallets.
Temperature-sensitive materials are stored here, guaranteeing optimal preservation at all times.
Picking and dispatch
Orders are prepared in this area. All operations are computerised and verified before dispatch.
Quality Control
Antibiotics Plant (Cephalosporins)
The Quality Control Department of the Antibiotics Plant operates a fully independent laboratory dedicated to cephalosporin antibiotics, comprising a Chemical Control area and a Microbiological Control area.
We comply with the strictest legislative requirements in both methodology and instrumentation, with a wide range of equipment including HPLCs, gas chromatographs, automated dissolution systems, infrared spectroscopy, UV-Vis spectrophotometers, X-ray diffractometers, autoclaves, and more.
General Plant
The Quality Control Department of the General Plant also comprises highly qualified professionals and state-of-the-art technology for the release of all pharmaceutical forms, particularly sterile products. This Department includes Physicochemical Quality Control and Microbiological Quality Control. To ensure the quality of both raw materials and manufactured products, a wide variety of qualified equipment is used, including isolators, Steritest systems, HPLC/UPLC, infrared spectroscopy, gas chromatographs, dissolution testing equipment, UV-Vis spectrophotometers, sub-visible particle counters, and various climatic chambers. Moreover, analytical methods are applied in accordance with the strictest quality standards.
Quality Assurance
This department ensures that the quality system is properly implemented across the various technical departments, guaranteeing compliance with Good Manufacturing Practices (GMP) and other applicable regulations (CE marking, ISO 13485).
As a Japanese company, the quality vision follows the Kaizen philosophy, which emphasises continuous improvement. This area is responsible for reviewing and controlling batches prior to release to the market, managing suppliers and services (including conducting audits), providing training for technical staff, and participating in the review and qualification of equipment and facilities.
