Kingchem’s Wisconsin facility, acquired in 2018, was inspected by three FDA investigators over a five-day period.  After the week long inspection, the investigators commended the facility for their quality systems and concluded the audit with a single item 483.  The resolution for this minor observation was already initiated prior to the FDA close out meeting, at which the investigators again commended the QA team for their swift action.  Kingchem looks forward to the formal written close out documentation from the FDA which is expected to be received in Q1 2022.

Kingchem Laboratories Inc. (St. Francis, Wisconsin, USA) has extended Kingchem’s capabilities to include full cGMP production for pharmaceutical intermediates as well as APIs. The North American manufacturing facility, Kingchem’s first in the US, offers an experienced team that can engage at every phase of drug development, from pre-clinical through commercialization. The production assets at Kingchem Laboratories range from pilot plant to full commercial scale and include a variety of materials of construction including glass-lined, stainless steel, and Hastelloy.

For further information concerning the facility, also see: https://www.kingchem.com/manufacturing/manufacturing-locations/kingchem-laboratories-inc/

For more information, contact Kingchem Life Science LLC.

The new API Material Handling & Packaging Room at Kingchem’s St. Francis Wisconsin (USA) GMP plant has been completed. While a state-of-the-art ISO 8 (Class 100,000) heating and ventilating system controls foreign particulate matter and guarantees environmental conditions, airlocks also provide for gowning, de-gowning, controlled access and appropriate equipment and material handling.

Electrically classified as Class 1 Division 2 Groups C&D to allow for the safe handling of flammable solvents, the room also features a walk-in hood, a spot ventilation arm, appropriate wall, ceiling, and floor finishes cleanable to pharmaceutical standards, as well as lighting levels appropriate to the processes carried out. With the airlocks, there is also separate single-direction flow of personnel from that of equipment and materials.

Designed to both protect the product and employees, the area is also flexible in its operations by use of portable equipment and donning PPE appropriate for the operation to be executed.  Most activities will focus on final packaging, for example, sampling from bulk containers and sub-dividing to client-requested configurations, etc. Other operations will include the de-lumping of bulk materials utilizing sieving equipment.

The new half-million dollar construction project now also provides viewing windows to allow customers to see the space and observe processing of their materials without entering the handling area. The area also allows for additional technologies to be added in the future to the Wisconsin plant, for example, solids handling such as milling operations, or handling more potent compounds in the area.

For further information, contact Kingchem Life Science LLC.

Another major expansion to Kingchem’s Liaoning Life Science plant at Fuxin (Liaoning China) has been completed. The new 2200m2 (~23,680ft2) Technology Center covers four floors, has a combined staff of 60 employees, and houses the plant’s QC and QA labs, four R&D labs and two Kilo labs. Production management and related administrative areas are also housed in the building.

The new 2.5 million-dollar (USD) Technology Center expands the Fuxin plant’s analytical capabilities, such as elemental analysis of ICP-OES Agilent 5800, UPLC Agilent 1290, NMR analysis, and the different levels of scaled-up production capabilities. As well, it also features a reversed QC lab which will be used for GMP analysis.

For further information, contact Kingchem Life Science LLC.

A Message to the Employees of Kingchem Laboratories of Wisconsin and Kingchem Life Science of New Jersey.

By Lillian Wu, Chief Operating Officer.

Both Wisconsin and New Jersey have been hard hit by the pandemic and so this has been a very stressful time for all of us. Yet, as a supplier to the pharmaceutical industry, Kingchem is classified as an essential business so it must continue to function. And it has, thanks to the dedication and diligence of the employees of Kingchem. During this difficult year, each has made a valuable contribution to Kingchem, the economy and the community at large.

This has been an exceptionally unique time of real and difficult challenges presented by world around us to both ourselves and to our families. To cite just a few examples: some contend with the blurring of the line between personal and work lives by working remotely; some need to continue being onsite and to work safely to operate basic infrastructure; some have confronted family issues. Yet, in the face of it all, Kingchem employees have continued to provide our customers with outstanding service. In other words, you have supplied and continue to supply the resilience and commitment to help us keep getting through.

This is very humbling for me to reflect on.

So, to each and every member of Kingchem, I want to express my very sincerest and deepest gratitude for a job well done. I am proud of you. You have been and will continue to be the strength of this company. Thank you for your teamwork, consistent effort and commitment.

I send you my warmest wishes for a happy holiday season and the very best for the coming new year.

Very sincerely,

Lillian Wu

A second major expansion to Kingchem’s Dalian R&D facility has been completed. The renovation included expanding into brand new labs & offices, as well as improvements to existing labs & warehousing.

The new expansion includes:

With this new expansion to 35,000 ft2 (3,300m2) Kingchem will offer new capabilities for the development of flow reaction such as hydrogenation, lithiation, nitration, oxidation or halogenation in flow. The company will also be able to provide better development services around pressure reactions, safety evaluations & expanded NMR analysis capabilities.

For more information, contact Kingchem Life Science LLC.

Kingchem is pleased to announce that its Kingchem Liaoning Chemical Co. plant located in Fuxin, Liaoning has resumed production and was fully operational as of 15 September 2020. The now expired shutdown was put into effect after an incident occurred at a waste-water treatment plant serving the overall industrial park where Kingchem’s plant is located. The full resumption of operations was based on notice received from local authorities. Kingchem emphasized that the employees of the plant and the plant itself were always safe throughout the incident. As well, Kingchem’s employees continued to work with the industrial park to help resolve the park’s issues triggered by the incident. Kingchem also took the shutdown as an opportunity to conduct numerous plant EHS improvements and perform annual maintenance, all of which smoothly passed the local authority’s EHS inspection. The company is also evaluating strategic long- and short-term solutions available in order to minimize any possible risk of interruptions to production that might be caused by a third party.

Although the shutdown was triggered by the park wastewater treatment plant, Kingchem apologizes for the delay caused to each impacted customer and is fully committed to minimize any delays in product delivery.

Customers are asked to communicate with their corresponding business team member for product delivery schedule updates.

Kingchem Statement to Our Customers on the Coronavirus Outbreak

Kingchem Life Science LLC of New Jersey and Kingchem Liaoning Chemical Co., Ltd. of Fuxin, Liaoning Province, China have been monitoring the Coronavirus outbreak in China carefully. We are fortunate to be able to report that our manufacturing plant in Fuxin and our R&D center in Dalian are located far from the epicenter of the outbreak and have not been impacted. Our manufacturing plant has been open and operating this entire time, including during the New Year’s celebration period.

To minimize the risk of virus contamination, we decided to have our Shanghai employees and a number of our Dalian office employees safely work from home. Further, it should be noted that Kingchem has no operations in or near the Wuhan area of China, and no Kingchem employees have been subjected to the outbreak. In fact, Kingchem took the safe approach and stopped purchasing all raw materials from Hubei province as soon it was learned that the coronavirus outbreak had occurred in Wuhan.

Also upon the outbreak, the Kingchem Liaoning Chemical Co. quickly went ahead to form an anti-virus committee to enable us to put into place a business continuity response of monitoring the outbreak, looking for any potential impacts on daily plant operations, monitor suppliers for impacts, follow any required government regulations, ensure support of our employees with equipment such as the daily distribution of masks, etc. and to take a number of other actions to minimize the risk of virus contamination. As a consequence of all of the preceding, we are pleased to report that our operations and shipments continue as normal.

Finally, customers concerned about travel to China at this time may want to consider video, web or audio conferencing, and may rest assured that Kingchem will take any and all steps necessary to assist you in this way.

We appreciate the understanding and support from our customers during such a challenging time. We will continue do our best to manage our day to day activity and will keep you informed of any changes in the situation.

(We invite you to also review our other Newsroom item entitled “Kingchem & Social Responsibility in the Face of Adversity: The Coronavirus Outbreak” concerning the contributions of Kingchem and our American employees to the Fuxin branch of the Red Cross of China and local municipal government’s struggles against the virus in the face of local shortages of protective masks, gloves, goggles etc.)

For more information, contact: Kingchem Life Science LLC

News Release

 Kingchem & Social Responsibility in the Face of Adversity – The Coronavirus Outbreak…

A Message from the CEO:

With the outbreak of the new coronavirus, the people of China found themselves in an unprecedented struggle during the recent Chinese New Year (Spring Festival). All employees of Kingchem would like to express their sincerest gratitude and respect to the medical workers struggling on the front line of the outbreak and, as well, to all others involved in the fight against the virus.

As a responsible global citizen and social enterprise, Kingchem has spared no effort to contribute to controlling the outbreak. For example, the hearts of our American Kingchem Life Science employees were touched as they saw the shortage of supplies in China growing alongside the epidemic. They quickly began organizing the donation of protective materials to the Fuxin branch of the Red Cross of China.

In spite of supplies such as medical masks and protective suits becoming very scarce on the American market, Bryan Rude of our Wisconsin plant, and Peter Jamieson and Ryann Rykowski of our New Jersey office worked very hard to find various types of medical protective equipment from suppliers far and wide. Disregarding high costs and other difficulties, they finally managed to find and purchase more than 500,000 RMB worth of protective supplies.

U.S. employees Guido DeMarco, Peter Jamieson, Ryann Rykowski, Ray Segura, Cathy Penetra, and Carmine Covino all actively contributed to packing pallets and preparing shipping documents. As a result, the first shipment of donations left our Allendale, New Jersey warehouse for China at 7 p.m. on February 5. And, after a prolonged second effort, a second shipment was finally dispatched to China late in the day, February 14.

Details of the first shipment included include:

While the second batch of donations included:

I want to express my appreciation and gratitude to everyone involved in the donation by Kingchem Life Science to the fight against the virus by the Fuxin Branch of the Red Cross of China.

Notably, Kingchem’s manufacturing and R&D facilities in China are far from the epicenter of the Coronavirus outbreak. However, Kingchem quickly set up a business-continuity anti-virus group for epidemic prevention and control, especially at our Kingchem Liaoning Chemical Co., located in the city of Fuxin (Liaoning province) China. The group’s ongoing mission is to organize and inspect our daily epidemic prevention-and-control work in order to ensure that production not only continues but also concurs with related government requirements and regulation during the epidemic.

It is commendable that our plant in Fuxin never shut down during Chinese New Year. Many of our personnel stuck to their work, while others returned to work early to help our company contend with the epidemic and ensure safe, ongoing production (to cite but one example, our manufacturing plant took the safe approach and stopped purchasing all raw materials from Hubei province as soon it was learned that the coronavirus outbreak had occurred in Wuhan). Other employees, unable to return to work, re-started work by email, teleconference and other means. We take this opportunity to express our very sincere thanks to both the management and the entire workforce of our manufacturing and R&D facilities for their efforts during the epidemic.

As we hope things begin to return to normal, I am reminded of the first words of the Kingchem company credo:

Kingchem is committed to serving the life science industry with passion, responsibility, integrity, and a loving heart. We carry out our work with energy, spirit, reliability, and quality standards. We commit to delivering high quality product to each of our customers around the world. Our mission is to improve the quality of life for all of humanity…

Our employees, in response to the epidemic, have proven the truth that lies behind our credo.

Signed,

Stephen Wang

Chairman and CEO

Kingchem

Carmine Covino, Vice President of Sales, Nutraceuticals has announced Kingchem Life Science’s 2020 Nutraceutical trade-show attendance schedule. Kingchem Life Science will be represented at the following Nutraceutical-focused shows in 2020:*

Vice President Covino also said, “Trade shows are important not only for meeting colleagues and expanding one’s base of potential business partners, but also for exchanging ideas, gaining a fresh perspective on industry sectors and keeping up with trends. Anyone who has been in the industry for some time will also tell you that they can really help shorten the negotiating and purchasing process quite a bit”

To meet with Kingchem Life Science at any of the above shows, please contact Carmine Covino at email address: [email protected]

For further information, contact Kingchem Life Science LLC.

* For a full list of shows attended by Kingchem personnel of all divisions, see http://www.kingchem.com/trade-shows/)

Kingchem is very pleased to welcome Dr. Holger Bastian to the Kingchem family of companies. He joins our team as the Director of Sales of Kingchem Life Science of Allendale, New Jersey (USA). Dr. Bastian achieved his doctorate from the University of Bielefeld in Germany and has been serving the global life science and chemical industries for over twenty-five years. Through his sales, marketing and business management experience, he brings to Kingchem extensive commercial and project management expertise, as well as a thorough business knowledge of the European region. His recent service at Rohner AG and AllessaChemie also provides him a thorough understanding of customer requirements in the pharmaceutical, fine chemical and agrochemical industries. This high level of experience and expertise — along with his convenient location in the heart of Europe – allows him to function as a very valuable asset to customers. Dr. Bastian is currently based in the Frankfurt area of Germany.

For more information, contact Kingchem Life Science LLC.

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