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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
  • Various recombination contracts
  • 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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Fukuda's leak test, leak inspection, leak detection, leak test, integrity test.

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Fukuda Co., Ltd. has been pursuing leak detection for 60 years and is committed to advancing the future of leak testing. 【 Supporting Various Leak Tests: Air Leak Test / Gas Leak Test (Hydrogen Gas, Helium Gas) 】 We develop, manufacture, and sell leak testing equipment to inspect airtightness and sealing properties. We will propose the appropriate testers and devices for each inspection target. 【 Target Industries and Examples of Inspection Targets 】 - Automotive Industry: Engines, FC components, valves and piping, various parts - Electronic Components Industry: Smartphones, keyless switches, various small sensors - Pharmaceuticals / Food / Cosmetics Industry: Bottle containers, syringes, vials, eye drop containers, pillow packaging, PTP packaging We will propose the most suitable leak testers for each industry. 【 ISO Certification 】JIS Q 9001:2015 (ISO 9001:2015)

Jan 23, 2026

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Non-contact light beam touch sensor "HA-T Series"

【Catalog now available!】Energy-saving automatic door sensors "HA-T401/HA-T520"

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  • CATALOG

The "HA-T Series" is an energy-saving automatic door sensor that opens only for those who wish to enter, whether on a busy street or in a narrow passageway. The automatic door opens simply by bringing your hand close, addressing hygiene concerns even in facilities used by a large number of people. You can choose between "Non-vision Mount Type/HA-T401" and "Non-vision Built-in Type/HA-T520" depending on the application and installation location. 【Recommended for such places!】 ☑ Entrance facing a busy corridor ☑ Presence of counters or signs near the door ☑ Buildings facing narrow passages ☑ Buildings that prioritize aesthetics ☑ Hospitals and facilities that consider hygiene ☑ Large facilities with many doors 【Features】 ● Adaptable to various door types with four detection spot settings ● Reduces unnecessary opening and closing, contributing to energy-saving by minimizing wasteful power consumption ● Equipped with a light touch function, allowing the door to open and close just by waving your hand, ensuring hygiene ● Can also be used as a wide detection range non-vision infrared sensor ◎ For more details, please download the materials or contact us.

Jan 23, 2026

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■■ Air Leak Tester | FLA-0200 / FLA-0201 series ■■ Fukuda's new flagship model. Equipped with mastering correction function, it enables high-precision measurements in a short time.

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Fukuda's new flagship model. - Masterless type (FLA-0200 series) - General type (FLA-0201 series) Two models of air leak testers. With the mastering correction function, high-precision measurements can be achieved in a short time. Please take a look at the catalog.

Jan 23, 2026

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PFAS Regulation Countermeasures! ■■ Leak Test Equipment for Small Electronic Components|MSA-0101 series ■■ Does not use fluorinated inert fluids. PFAS-free. Offers accuracy equal to or better than liquid immersion testing.

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● This is a leak testing device for small electronic components that does not use fluorinated inert liquids (PFAS-free). ● There is no longer a need for unstable visual confirmation through liquid immersion testing. It adopts a quantitative testing method that allows for stable pressure leak testing. ● It is a tabletop leak testing device specifically for gross leaks, with accuracy equal to or greater than that of liquid immersion testing. ● The detectable range is approximately 1×10⁻² Pa·m³/s to 1×10⁻⁶ Pa·m³/s (varies depending on the target product). ● It is suitable for sealed structures ranging from a few millimeters to a maximum of 80 × 70 mm. Please feel free to contact us for more information!

Jan 23, 2026

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PIAB [Introduction of Innovation Video] Wrap Packaging and Suction Conveyance of White Trays for Food *Exhibited Product at Robodex Tokyo 2025*

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Introduction of "Piab Original Hand" At Piab, we have successfully achieved suction transport of "white tray wrap packaging," which has received many requests from the food industry, without leaving any suction marks. We will propose specifications that best meet your needs, including custom sizes. Please contact us first! (Piab Japan Co., Ltd.) Here is the video (YouTube) https://youtu.be/YIsCkhF3GhQ

Jan 23, 2026

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  • 10個まで5日で出荷 ロータリーエンコーダ 9,500円~16,600円(税別) Φ30、Φ40mm 100~4000P/R 磁気式インクリメンタル形
  • 展示会に出展したいけど準備が大変 展示会の情報をまとめて知りたい そんな展示会のお悩み 展サポ(R)で解決! ブース装飾で実績豊富 展示会情報を多数掲載 出展前~後まで支援
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