Made in America

Support demand planning, business continuity, and long-term growth with domestically produced hard capsules.

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Recent trade developments and domestic capacity shifts are changing the hard empty capsule sourcing landscape in the U.S. Final antidumping (AD) and countervailing duty (CVD) determinations now apply to hard empty capsules imported from China, India, Brazil, and Vietnam, cementing duties ranging from 8% to 88% for the next five years on top of existing, volatile tariff policies. In parallel, the announced closure of a major U.S. capsule manufacturing site by the end of 2026 will further reduce domestic capacity, reinforcing the need for proactive continuity planning.

Lonza Capsugel Greenwood provides established U.S.-based capsule manufacturing and qualification support to help customers stabilize supply and plan confidently for future programs and expansions.

Why U.S.-based capsule continuity matters now

  • Current geopolitics and tariff policies increase landed cost volatility and supply chain planning complexity
  • Domestic manufacturing capacity for hard empty capsules is shifting with reduced U.S.-based supply options impacting overall supply/demand
  • Qualification timelines in the pharmaceutical industry make short-term, reactive supplier changes difficult and costly to manage

What industry leaders are doing now

  • Proactively qualifying U.S.-based capsule supply to reduce exposure to trade volatility and support long-term planning
  • Aligning quality assurance (QA), chemistry, manufacturing, and controls (CMC), and procurement teams early to streamline second-source qualification and avoid sequential delays
  • Staying ahead of evolving regulatory expectations, including reviewing capsule materials and colorant strategies as requirements shift

Why Lonza Capsugel Greenwood

  • Established U.S. manufacturing with over five decades of capsule production experience, supporting consistent quality and regulatory confidence
  • Pharmaceutical-focused quality systems designed to meet global regulatory expectations and support evolving requirements
  • Qualification-ready documentation support, including quality system summaries, conformance statements, and drug master file (DMF) support where applicable
  • Vendor managed inventory (VMI) and collaborative supply planning to help customers manage demand variability and strengthen business continuity
  • Scalable U.S. supply supporting programs from clinical development through commercial manufacturing

Explore our portfolio of U.S.-manufactured hard empty capsules produced at our Greenwood, SC facility.

Plan now for 2026 and beyond

Qualification timelines make proactive planning essential for continuity and future program stability. Our team can support your next steps.

You might be interested in:

  • Speaking with a capsule expert about U.S.-based supply options
  • Requesting samples for evaluation or formulation work
  • Starting a Lonza Capsugel Greenwood qualification discussion
  • Reviewing documentation to support QA and regulatory planning
  • Exploring secondary sourcing strategies
  • Discussing demand planning, vendor managed inventory, or supply continuity support

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