Reshoring and Expanding API Manufacturing Capabilities

Manufacturers in Europe and the United States have announced plans for new in-country API development and manufacturing capabilities. Citing the need to balance reliance on API sourced from other regions, in February 2020 Sanofi created a standalone company out of the combination of Sanofi’s API commercial and development activities at six of its European production sites (1). Sanofi said the spin-off company, to launch in 2022 with the name EUROAPI and headquarters in France, would allow greater agility to improve supply security (2).

Seqens, with the support of the French government, is adding flow chemistry capabilities at its R&D center and four industrial sites in France. The multi-purpose units will produce non-good manufacturing practice (GMP) intermediates in the short term, and APIs in the long term, including anesthetics, antivirals, and other small molecules (3).

In the US, Oregon-based contract development and manufacturing organization (CDMO) Cascade Chemistry began construction of five suites for Phase I and II current-GMP (CGMP) manufacturing in February 2021, and the company plans to add Phase III and commercial CGMP-scale capacity in 2022 (4).

CDMO Regis Technologies is expanding its laboratories in Illinois and installing equipment, including kilo-scale reactors, to develop APIs. The company reported a growing demand for domestic API development and manufacturing (5).

References

1. Sanofi, “Sanofi to Create New Industry Leading European Company to Provide Active Pharmaceutical Ingredients,” Press Release, Feb. 24, 2020.

2. Sanofi, “Sanofi Unveils EUROAPI as the Name of the New Industry Leading European API Company,” Press Release, Jan. 12, 2021.

3. Seqens, “Seqens is Committed to the Development and Production of Critical Molecules in France,” Press Release, Nov. 20, 2020.

4. Cascade Chemistry, “Cascade Chemistry Initiates $14 Million Expansion of CGMP Pharmaceutical Manufacturing Capacity,” Press Release, Feb. 18, 2021.

5. Regis Technologies, “Regis Expands Facilities to Support Rising Demand for US-Based Custom API Pharmaceutical Development and Manufacturing,” Press Release, Feb. 17, 2021.

About the author

Jennifer Markarian is manufacturing editor at Pharmaceutical Technology.

Article details

Pharmaceutical Technology
Vol. 45, No. 4
April 2021
Pages: 18

Citation

When referring to this article, please cite it as J. Markarian, "Reshoring and Expanding API Manufacturing Capabilities,” Pharmaceutical Technology 45 (4) 2021.