Almac Pharma Services Receives Brazilian ANVISA GMP Certification for US Facility

Almac Pharma Services, a member of the Almac Group providing product development, manufacturing and commercial services to global pharmaceutical and biotech organisations, has received its ANVISA GMP Certificate for the company’s Pennsylvanian facility, which approves the site for supply of products into Brazil.

An ANVISA GMP certificate is issued by the Brazilian Health Regulatory Agency (ANVISA) to confirm that an establishment complies with the technical requirements of Good Manufacturing Practices (GMP) needed for commercialising a product, according to the current law.

The facility, located in Audubon, is an established, FDA approved site offering a range of specialist pharmaceutical product launch and commercial supply solutions including complex patient kit processing and complements Almac Pharma Services’ three European locations.

Harry Lindenmuth, VP Operations and Audubon Site Head, Almac Pharma Services, said: “This certification marks an important regulatory milestone for our facility in Audubon, PA.  It represents further evidence of our continued commitment to offering best-in-class, quality-led and tailored services for our clients, and the patients they serve.

“This accomplishment is testament to the continued progress in developing the site by the Audubon team.  Congratulations to everyone involved in making this possible. We look forward to the continued growth of Almac Pharma Services in the US.”