Start-to-finish collaboration

About ZACROS

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.
	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.

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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 utmost 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 diverse materials together guarantee we can create your optimal package.

Learn more about our facilities

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.

Facility introduction

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

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 acquired ISO 15378 and ISO 13485 certifications, and passed multiple audits from both the prefectural government and our clients.
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 9001:2015 with reference to Good Manufacturing Practices (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

ISO13485:2016, EN ISO13485:2016

Certified standards	ISO13485:2016, EN ISO13485:2016
Registrar	BSI
Registration date	2021/6/29
Scope of registrar	Manufacture of Chips for In Vitro Diagnostic Medical Device(Haemostasis Testing) Manufacture(Packing) of Accessories(Reservoir Set and Sterilized Blood Collection Tubes) for In Vitro Diagnostic Medical Device(Haemostasis Testing)
Registration number	MD 741700

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.