ACS Biomed Initiates LATAM Regulatory Programme for ErpeCream® and ErpeLips®
Regulatory submissions in Mexico and Brazil represent the first step towards commercialisation across key Latin American markets.
ACS Produzioni Biomed S.r.l. (“ACS Biomed”), an Italian biotechnology company developing innovative topical solutions for Herpes Simplex Virus (HSV) infections, has officially initiated the regulatory programme supporting the commercial launch of ErpeCream® and ErpeLips® across Latin America.
The programme follows the execution of the company's exclusive five-year distribution agreement with Axentra Pharma, covering Mexico, Brazil, Venezuela, the Dominican Republic and selected Central American markets. As part of the implementation of this partnership, regulatory submissions are scheduled to commence with COFEPRIS in Mexico and ANVISA in Brazil, representing the region's two largest healthcare markets.
The regulatory programme represents a key operational milestone in ACS Biomed's international expansion strategy and provides the framework for the future commercialisation of both products throughout Latin America.
A Structured Regulatory Roadmap
ACS Biomed has adopted a phased regulatory strategy designed to facilitate market entry while supporting the long-term positioning of its HSV product portfolio.
The initial submissions in Mexico and Brazil will be made under the dermocosmetic regulatory pathway, allowing the company and its commercial partner to establish an early market presence while complying with local regulatory requirements.
Following the initial registrations, ACS Biomed intends to pursue the Medical Device Class I regulatory pathway, where applicable, as part of its broader international regulatory strategy. This phased approach reflects the company's objective of combining commercial execution with continued product development across multiple jurisdictions.
Additional regulatory programmes for the remaining territories covered by the agreement will be implemented in accordance with the commercial rollout plan agreed between ACS Biomed and Axentra Pharma.
Supporting International Commercial Expansion
Latin America represents one of the world's largest markets for recurrent HSV infections, creating significant opportunities for innovative topical healthcare products supported by scientific research and proprietary formulation technology.
The regulatory programme is a fundamental component of the exclusive distribution agreement and is designed to support the progressive introduction of ErpeCream® and ErpeLips® across the contracted territories.
Working in partnership with Axentra Pharma, ACS Biomed aims to establish a structured commercial presence in the region while ensuring that all regulatory activities are conducted in accordance with the requirements of the relevant national authorities.
Building a Global Regulatory Platform
The LATAM regulatory programme complements ACS Biomed's broader international strategy, which combines European commercial operations, ongoing clinical development and international distribution partnerships.
By advancing regulatory activities across multiple regions, the company continues to build a global framework capable of supporting both current commercial opportunities and future pharmaceutical development.
The initiation of submissions with COFEPRIS and ANVISA therefore represents more than an administrative milestone. It reflects ACS Biomed's commitment to expanding internationally through a structured, science-driven and regulatory-focused approach, creating the foundations for long-term growth across some of the world's most important healthcare markets.