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  1. Home
  2. Pharmaceuticals and Biotechnology
  3. リブラメディシーナ
  4. Libra Medicine's partner company, Mycenax Biotech Inc., has received conformity approval from the European Medicines Agency (EMA).
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  • Apr 01, 2025
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Apr 01, 2025

Libra Medicine's partner company, Mycenax Biotech Inc., has received conformity approval from the European Medicines Agency (EMA).

リブラメディシーナ リブラメディシーナ
Our partner company, Mycenax, conducted an on-site inspection by the EMA (in January 2025) and received formal periodic synthesis approval notification in March 2025. As a result, we have completed inspections by regulatory authorities in Japan, Canada, and Europe over the last two quarters and received official "pass" notifications. 【Health Canada】 (October 2024) – Conducted a 5-day on-site inspection, completed one day ahead of schedule. Received formal "pass" notification in December 2024. 【PMDA】 (November 2024) – Conducted a 4-day on-site inspection, completed half a day ahead of schedule. Received formal "pass" notification in February 2025. 【EMA】 (January 2025) – Conducted a 10-day on-site inspection, completed two days ahead of schedule. Received formal "pass" notification in March 2025. The fact that these inspections were completed earlier than initially planned indicates that Mycenax's manufacturing facilities and quality management systems are highly regarded by international regulatory authorities.
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[Presentation of Materials] Contract Development and GMP Contract Manufacturing of Biopharmaceuticals

By achieving consistent DS and DP manufacturing within the same facility, the need for multiple contract management, material transportation, and technology transfer is minimized! [Exhibiting at BioPharma Expo]

We are the exclusive agent in Japan providing contract manufacturing and GMP contract manufacturing (CRO/CMO) services for biopharmaceuticals from Mycenax Biotech Inc. We offer contract research and manufacturing services for monoclonal antibodies (mAb), bispecific and multispecific antibodies, antibody-drug conjugates (ADC), enzymes, recombinant proteins, cell therapy products, and plasmid DNA. All manufacturing operations comply with PIC/S GMP standards and meet international regulations. By integrating LIMS and QMS, we achieve an efficient and high-quality manufacturing system. 【Features】 ■ Quality system compliant with GMP and with a track record of regulatory inspections ■ Consistent manufacturing of active pharmaceutical ingredients (DS) and formulations (DP) at the same facility, reducing costs and risks ■ Equipped with dedicated manufacturing facilities that accommodate CHO cells, E. coli, human cell lines, and high-potency formulations \ For more details, please check "Download Catalog" /

  • Contract manufacturing
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  • Other Contract Life Science Specialization

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Related catalog(1)

Contract development and GMP contract manufacturing of biopharmaceuticals (MYCENAX Company Introduction)

Contract development and GMP contract manufacturing of biopharmaceuticals (MYCENAX Company Introduction)

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リブラメディシーナ
Pharmaceuticals and Biotechnology
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【Metal Crack Repair】We repair cracks in metal products without applying heat.

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The "Mechanical Stitch Method" by Nichinichisui Road Machinery Co., Ltd. is a new technique that allows for the repair of metal cracks without the application of heat. By using special bolts and reinforcement plates, cracks are physically removed, and repairs are made without causing any thermal impact to the base material. Repairs can be carried out in environments where open flames cannot be used. Since no heat is applied, the disassembly of equipment is minimized. ◎ For more details, please contact us. ◎ If a detailed technical explanation is needed, please contact us.

Dec 09, 2025

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[Cast Iron Crack] We will repair cracks in metal products without applying heat.

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The "Mechanical Stitching Method" by Nichinichisui Road Machinery Co., Ltd. is a new technique that allows for the repair of metal cracks without the application of heat. By using special bolts and reinforcement plates, cracks are physically removed, and repairs are made without causing any thermal impact on the base material. Repairs can be carried out even in environments where open flames cannot be used. Since no heat is applied, the disassembly of equipment is kept to a minimum. ◎ For more details, please contact us. ◎ If a detailed technical explanation is needed, please contact us.

Dec 08, 2025

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Please take a look at Fukuda's digital pressure gauge!

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"MI-170 series" With RS-232C communication, measurement result output and setting data input/output can be performed. Up to 8 types of condition settings, such as upper and lower limit settings, can be configured. Pressure sensors can be selected from 4 types based on accuracy, gauge pressure, and differential pressure. The mounting size conforms to the DIN96 standard. By combining with the separate type air leak tester LPU-100 series, it can also be used as an air leak tester. "DG-960 series" Pressure sensors can be selected from 4 types based on accuracy, gauge pressure, and differential pressure. The mounting size conforms to the DIN96 standard. "MIZ-0175 series" A new multi-indicator that enhances the functionality of the versatile and high-performance conventional model "MI-170," improving operability and visibility through downsizing and the adoption of an LCD display. It allows a maximum sampling rate of 4000 times per second for stable measurements and is equipped with various correction functions and noise cancellation features, providing a wealth of functionalities.

Dec 08, 2025

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Please take a look at Fukuda's flow meters! (Flow Tester, Flow Unit, Laminar Flow Meter)

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● What is a flow meter? Flow meters measure flow rates using mass flow meters or laminar flow meters and perform pass/fail judgments based on flow rate criteria. They are ideal for measuring airflow and conducting performance tests. "FMZ-1063 series" This is a flow tester equipped with a mass flow meter. It offers high precision of ± 3.5 % of R.D. ± 1 digit (in the normal flow range). It features a time-saving function (scan measurement). The FMZ-1063 is a compact, all-in-one flow tester with various functions. "FU series" This is a flow measurement unit that integrates laminar and differential pressure sensors, making it smaller and lighter. When connected to a display indicator (model: MI-170), it can provide direct flow readings as well as pressure and flow judgments. "FLF-110 series" This is a laminar flow meter capable of measuring a wide range of flow rates from 2 NmL/min to 500 NL/min.

Dec 08, 2025

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Please take a look at Fukuda's air leak tester!

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What is an Air Leak Tester? An "Air Leak Tester" is a device that pressurizes the inside (or outside) of a sealed workpiece with air and determines the presence of leaks based on pressure changes. When a master with no leaks and a workpiece with leaks are pressurized, the pressure on the workpiece side decreases, creating a pressure difference between the two. By measuring this pressure difference, the presence of leaks can be determined. Generally, differential pressure air leak testing is widely used, but Fukuda also offers products that utilize direct pressure leak testing and flow meters according to the leak rate, in addition to differential pressure leak testers. Since the air leak tester uses air as the measurement medium, it incurs no running costs and is environmentally friendly.

Dec 08, 2025

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