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About ZACROS

Fujimori Kogyo, also known as ZACROS, is a Japanese converter of flexible films and packaging which was established in 1914. Besides healthcare, the ZACROS Group also supplies the business fields of personal care, electronics, IT and infrastructure.

ZACROS is capable of offering full support for your projects. We value quality and team work, and have R&D and manufacturing facilities to meet your needs.
Non-interactive films

Full support until fill and finish

ZACROS offers technical support throughout product launch and your go-to-market strategy.

Prototype packaging
samples

Technical assessment of
material and components

(including closures)

Actual filling tests with
drug solution

Close connection with CMOs

With our extensive global network, we can match you with the best CMO based on your needs.

Expertise in regulatory support

Our staff are well versed in USP and JP guidelines, and have supported submissions to FDA authorities. We have sold liquid medicine primary packaging to the US and Japan for over 30 years, and some products are DMF registered.

Our staff are well versed in USP and JP guidelines, and have supported submissions to FDA authorities. We have an over 30 year track record of selling IV bags to the US market, and over 10 years to the Japan market.

Our commitment to quality

 ZACROS takes the upmost care in managing quality of our products, because drug packaging directly affects patients.

Gaining ISO 15378 approval for manufacture and sale of pharmaceutical packaging, we operate our quality management at the same level as pharmaceutical manufacturers.
 
We have full control of our manufacturing processes and a vast portfolio of differentiated products. Precision manufacturing and co-extruding different materials together guarantee we can create your optimal package.

Quality

We are with you

Our research & development, engineering, quality, and sales teams have the synergy to meet your project needs.

We are based in Japan but our local staff in the US can directly support projects for the North American market.
Resources will be allocated promptly as our discussions evolve.
 

team work
team
team

Facility introduction

MediTect™ products are manufactured at ZACROS Mie Plant while our R&D Center offers opportunities for customized joint development.

Mie Plant

Mie Plant

Completed in 2012, Mie was designed and built as a pharmaceutical and medical packaging manufacturing plant with GMP philosophy as the base. It has aquired ISO 15378, ISO 13485, and undergone FDA audits as well. Maintaining equivalent quality levels to our pharma customers, and operating a one-machine-per-room philosophy, we deliver a new level of value and quality assurance in our products.

ISO15378:2017

Certified standards

ISO 15378:2017 : Primary packaging materials for medicinal products

Particular requirements for the application of  ISO 2015:9001, with reference to good manufacturing practice (GMP)

Registrar

SGS Japan inc.

Registration date

2019/12/6

Scope of registrar

Design, development and manufacture of the following pharmaceutical packaging materials, IV Bag, Sheet for IV Bag, PTP sheet and Single-use Bag for Pharmaceutical production processes.

Registration number

JP19/063094

ISO15378:2017

ISO13485:2016,  EN ISO13485:2016

Certified standards

ISO13485:2016,
EN ISO13485:2016

Registrar

BSI

Registration date

2021/6/29

Scope of registrar

1) Manufacture of Chips and Accessories for Blood Coagulation Testing for In-vitro Diagnostic Use.
2) Distribution of Tubes for Blood Coagulation Testing for In-vistro Diagnostic Use.

Registration number

MD 741700

ISO13485:2016,  EN ISO13485:2016
Research and development Center

Research and Development Center

Joint-development and innovation focused, our Research and Development Center is home to powerful evaluation equipment, all at your disposal.
 
The first floor has our Customer Relation Center where customers and visitors alike are encouraged to get to know ZACROS and its activities better.

Prototype Workshop

Small-scale modular equipment makes for quick sample creation.

Machinery Room

Filling machines for each type of packaging, sterilization systems, handling systems, and other semi-automated machines are available for testing and assessing custom packaging and contents.

Experimental Factory

A large area sectioned off at the R&D center for joint-development and in-house experimenting where quick testing and assessing is possible.

Isolator

Isolators make it possible to handle and perform tests with a wide range of pharmaceutical contents directly on our premises.

Equipment

3D Printer

3D Printer

Bag-Making Machine

Bag-Making Machine

Port-Sealing Machine

Port-Sealing Machine

Clean Room

Clean Room

Clean Bench

Clean Bench

Ultrasonic Welder for IV Bag Closures

Ultrasonic Welder for IV Bag Closures

Isolator

Isolator

Retort Sterilization Machine

Retort Sterilization Machine

ZACROS is your one-stop shop for
tailored-to-spec packaging solutions

Contact us today to learn more