Reshoring accelerates in life sciences, other industries see more
Some South Carolina-based suppliers are feeling a burst of demand as domestic content percentages for materials used in public projects are set to go into effect in October.
The Buy American Act – not to be confused with the Reagan-era Buy America Act – was first created in 1933 to give preference to domestic manufacturers.
The bill has evolved over the years, but in January 2021, the Biden Administration passed an executive order sparking “the most robust changes to the implementation of the Buy American Act in almost 70 years,” according to a White House news release.
The order raised the percentage of domestic content required in public projects from today’s 55% to 60% starting Oct. 22, according to a document published by Federal Register.
By 2024, the required percentage will climb to 65%, and in 2029, to 75%. The initial increase to 60% will occur several months from publication of the final rule, according to the Defense Department, General Services Administration and National Aeronautics and Space Administration document.
Andrew McAllister, partner with Washington D.C-based Holland & Knight, shared in a webinar that materials “manufactured in the United States” is not defined in the law, but that it implies a step beyond assembly.
“Then the second piece of that test is that the cost of the components from the U.S. must exceed a certain threshold of the cost of all components,” McAllister said, adding that iron and steel products undergo more strict standards.
Under the new ruling, foreign iron and steel must make up less than 5% of the total cost of components purchased.
“It doesn’t mean you can never offer a foreign product,” he said. “It’s more so you’re going to be penalized for providing that foreign product.”
Bringing it all home
The Buy American Act may often come up in conversations about building materials and construction products, but it also dictates procurement for other forms of federal infrastructure as well – for example, procedure trays used in tax-funded operating rooms.
COVID-19 wreaked havoc on medical product supply chains Greenville’s CPT Medical depended on for their company’s specimen collection supplies in 2020.
“A lot of it was not just made in China, but one of the largest specimen collection manufacturers COPAN is in Italy, and BD is in Germany,” said Austin Shirley, vice president of commercial operations at CBT Medical’s holding company Diversified Medical Healthcare. “So there was very little U.S. production.”
So, out of necessity, Diversified Medical Healthcare certified its viral transport medium for distribution and launched production. Being one of few domestic manufacturers, Shirley said they couldn’t fill orders fast enough.
An ongoing shortage of polypropylene wrap used to sterilize surgical instruments later prompted Diversified Medical Healthcare to seek out U.S. partners Hanes Fabrics.
So, when a federal customer came to CBT Medical with a request for medical supplies and the Buy American Act requirements in hand nine month ago, the OEM supplier was poised for action.
Now, about 67% of CBT products go toward facilities used by this federal customer, he said.
It hasn’t always been easy to find domestic suppliers – especially for plastics, textiles and nitrile rubber components– but Shirley said they’ve uncovered many U.S.-based suppliers able to supply CBT’s custom surgical trays.
Teasing out impacts
Jarrett Martin, president of Mar-Mac Industries, an industrial wire supplier for concrete reinforcement in McBee, said he has witnessed a positive uptick in U.S. suppliers used by the Florida Department of Transportation.
But, at this time, he said it is hard to pinpoint the booming demand for Mar-Mac products to the Buy American Act alone. More than 90% of his business comes from outside the Palmetto State.
“It has been difficult to tease out impacts to our business just with all the other noise going on in the supply chain disruptions, and before that, the pandemic, and before that, the steel tariffs from Section 232 by the Trump administration,” Martin told SC Biz News. “We expect a positive impact.”
Section 232 placed a 25% ad valorem tariff on steel imports from all countries except Canada and Mexico as a national security measure, according to the Executive Office proclamation.
Turmoil in the ocean freight market, along with ongoing lockdown in China due to COVID-19, forced many contractors to reassess of their suppliers before the Oct. 22 requirements come into place.
“Essentially, we saw demand snap back much more quickly than we expected after the spring of 2020, and nobody was ready for it,” Martin said. “Everybody in the supply chain had done the same thing. They had moved to conserve cash and take inventory down, expecting a big recession.”
The rise in ocean freight prices and the uncertainty of import times has proved kind to Mar-Mac Industries so far.
“As a domestic manufacturer, I’ve been well positioned to take advantage of that,” Martin said.
Agreement expands contract manufacturing services for Zeus customers see more
Zeus Industrial Products has agreed to integrate catheter-based contract manufacturer CathX Medical into its organization.
The financial terms of the agreement were not disclosed in yesterday’s announcement.
San Jose, Calif.–based CathX provides catheter design engineering services, rapid prototyping, manufacturing, and full or sub-assemblies. CathX’s leadership will continue to manage the San Jose facility, services, and team members under the global leadership of Zeus CEO Steve Peterson.
Zeus (Orangeburg, S.C.) has a core business centered on component manufacturing across medical and industrial markets. However, the integration with CathX extends Zeus’ capabilities to include contract manufacturing services for medical customers.
“Like Zeus, CathX is very much a ‘people-first’ company,” Peterson said. “We share the same core values across excellence, people, integrity and creativity, and are delighted to welcome the entire CathX team into our Zeus family.”
Life sciences executive named to national NAMB Board see more
Nephron Pharmaceuticals Corporation today announced CEO Lou Kennedy as a new member of the National Association of Manufacturers Board of Directors.
Kennedy, who was elected on Monday, joins the NAM Board to bolster the association’s leadership in policy advocacy, workforce solutions, legal action, operational excellence and news and insights. She will help the industry advance an agenda that promotes growth and prosperity for all Americans.
“I could not be more excited and honored to join the board,” said Kennedy. “Our team has been fortunate to work with NAM over the last few years on critical issues, from COVID-19 to workforce development, and we are always impressed by the results NAM delivers for its members, as well as for employers and employees across the nation.”
NAM and its members are at the forefront of every important policy debate for manufacturers and have led the nation’s response to COVID-19.
Board members play a key role in the NAM’s “Creators Wanted” campaign, a member-driven initiative to inspire and drive more Americans to pursue careers in modern manufacturing.
“Lou Kennedy is a recognized leader in our industry, and the NAM will be stronger thanks to her service on our Board of Directors,” said NAM President and CEO Jay Timmons. “Manufacturers are the driving force behind our economic recovery and our fight to defeat COVID-19. We are working with lawmakers to ensure they deliver the relief America needs and the long-term policy work on issues like infrastructure investment, immigration reform, trade expansion and workforce development. We will also defend the progress we’ve made on tax reform and regulatory certainty to ensure we can keep our promises to invest in our people and communities and build the strongest economy possible. The NAM’s mission is to ensure we always keep moving forward, and Lou will bring invaluable insights as we advocate for the men and women of our industry and advance the values that have made America exceptional and our industry strong — free enterprise, competitiveness, individual liberty and equal opportunity.”
A West Columbia, S.C.-based company, Nephron is a nationwide leader in the development and production of safe, affordable generic inhalation solutions and suspension products. The company also operates an industry-leading 503B Outsourcing Facility division which produces pre-filled sterile syringes and IV bags for hospitals across America, in an effort to alleviate drug shortage needs. The company recently opened a CLIA-certified diagnostics lab, conducts COVID-19 tests and administers vaccines. Nephron announced a new $215 million investment and expansion in July, signaling a new era of unprecedented growth, including the establishment of a vaccine production facility.
The National Association of Manufacturers is the largest manufacturing association in the United States, representing small and large manufacturers in every industrial sector and in all 50 states. Manufacturing employs more than 12.2 million men and women, contributes $2.32 trillion to the U.S. economy annually and has the largest economic multiplier of any major sector and accounts for 63% of private-sector research and development. The NAM is the powerful voice of the manufacturing community and the leading advocate for a policy agenda that helps manufacturers compete in the global economy and create jobs across the United States. For more information about the NAM or to follow us on Twitter and Facebook, please visit www.nam.org.
Market is currently valued at $770 million see more
Upsher-Smith Laboratories, LLC (Upsher-Smith) and AmbioPharm, Inc. (AmbioPharm) today announced that the companies have entered into a partnership agreement to develop and market Corticotropin Injection in the U.S. The market for adrenocorticotropic hormone or ACTH (brand Acthar® Gel*) is currently valued at $770 million (IQVIA, 12 months ending June 2020).
Under the terms of the agreement, Upsher-Smith will submit the New Drug Application for Corticotropin Injection to the U.S. Food and Drug Administration (FDA) and market and distribute it under its own label in the U.S. upon FDA approval. AmbioPharm will manufacture the active pharmaceutical ingredient exclusively for Upsher-Smith. A contract manufacturing organization will exclusively supply Upsher-Smith with the finished product for sale in the United States. Financial terms related to the deal have not been disclosed.
“We are excited to partner with AmbioPharm, a leader in the field of peptide development and manufacturing, to bring Corticotropin Injection to the U.S. market,” said Rusty Field, President and CEO of Upsher-Smith. “This agreement represents another step in Upsher-Smith’s and Sawai’s strategy to co-invest in highly complex generics and 505(b)(2) products that can drive long-term growth.”
Added Chris Bai, CEO of AmbioPharm, “We are pleased to bring our unsurpassed technical capabilities and peptide manufacturing capacity to our partnership with Upsher-Smith, a company with a long-standing tradition of bringing high-quality products to the patients who rely upon them.”
Upsher-Smith Laboratories, LLC is a trusted U.S. pharmaceutical company that strives to improve the health and lives of patients through an unwavering commitment to high-quality products and sustainable growth. Since 1919, it has brought generics and brands to a wide array of customers backed by an attentive level of service, strong industry relationships, and dedication to uninterrupted supply.
As Upsher-Smith begins its second century in business, the company enters a new ambitious era that has been accelerated by its 2017 acquisition by Sawai Pharmaceutical Co., Ltd. Upsher-Smith and Sawai plan to leverage each other for growth worldwide and embark on an exciting new chapter as they seek to deliver the best value for their stakeholders, and most importantly, Do More Good™ for the patients they serve. For more information, visit www.upsher-smith.com.
AmbioPharm, Inc. is a full-service peptide manufacturing company headquartered at its North Augusta, South Carolina, USA cGMP production site. Its second cGMP facility in Shanghai, China, performs process development and optimization and manufactures building blocks, raw materials, and custom peptides at a very large scale. Both of its cGMP facilities are capable of handling any manufacturing scale required to produce bulk peptides to custom specifications using a wide range of skill sets in both solid and solution-phase chemistry. Its management team has over 120 years of cumulative experience running a pilot to commercial-scale production. The Company also performs organic conjugations to small molecules, proteins, toxoids, antifungals, KLH, and PEG. For more information, visit www.ambiopharm.com.
Avara Pharmaceutical Services finalizes acquisition of GSK Consumer Healthcare facility in South CarolinaAvara Pharmaceutical Services has completed a South Carolina acquisition from GSK see more
Avara Pharmaceutical Services, a world-class contract development and manufacturing organization (CDMO), announced that the acquisition of the GlaxoSmithKline (GSK) consumer healthcare manufacturing facility in Aiken, South Carolina (USA) is complete. Read on for full details...