Onesource Specialty Pharma , a key player in the pharmaceutical industry, has achieved a significant milestone in its regulatory compliance efforts. The company recently received a 'Voluntary Action Indicated' (VAI) classification from the U.S. Food and Drug Administration (USFDA) for its crucial manufacturing facility located in Bangalore, India.

Understanding VAI Classification

The VAI classification is an important indicator in the pharmaceutical industry. It signifies that while the USFDA may have observed some minor issues during their inspection, these are not significant enough to warrant regulatory action. This classification essentially validates that ONESOURCE Specialty Pharma is maintaining compliance with regulatory standards, with only minor improvements needed.

Implications for ONESOURCE Specialty Pharma

This development is particularly noteworthy for ONESOURCE Specialty Pharma as it pertains to their key facility in Bangalore. The VAI classification serves as a testament to the company's commitment to maintaining high standards of quality and regulatory compliance. It also indicates that:

• The company's manufacturing processes and quality control measures are largely in line with USFDA expectations.
• Any observations made by the USFDA are likely to be addressed through the company's own quality systems and processes.
• The facility can continue its operations without any significant regulatory hurdles.

Industry Context

In the highly regulated pharmaceutical industry, maintaining compliance with USFDA standards is crucial for companies, especially those eyeing the lucrative U.S. market. The VAI classification puts ONESOURCE Specialty Pharma in a favorable position, potentially boosting confidence among stakeholders and customers.

Moving Forward

While the VAI classification is a positive development, it also implies that there is room for some improvement. ONESOURCE Specialty Pharma will likely focus on addressing any minor issues identified during the inspection to ensure continued compliance and potentially aim for a 'No Action Indicated' (NAI) classification in future inspections.

This development underscores ONESOURCE Specialty Pharma's ongoing efforts to align with global regulatory standards, a critical factor for success in the international pharmaceutical market.

OneSource Specialty Pharma Limited has achieved a significant milestone in its global expansion strategy. The company's flagship Unit 2 facility in Bengaluru has been granted Good Manufacturing Practice (GMP) certification by ANVISA, the Brazilian Health Regulatory Agency, following a successful regulatory inspection conducted in November 2024.

Key Highlights

• OneSource's Unit 2 receives GMP certification from ANVISA
• Approval enables the company to supply Drug-Device Combinations (DDCs) and GLP-1s to the Brazilian market
• Inspection was conducted from November 18 to November 22, 2024
• Brazil is poised to be one of the largest markets for generic Semaglutide in 2026

Expanding Market Access

The ANVISA approval marks a crucial step for OneSource Specialty Pharma, as it opens doors to one of Latin America's largest pharmaceutical markets. This certification specifically allows the company to manufacture and supply Drug-Device Combinations (DDCs) and Glucagon-like peptide-1 receptor agonists (GLP-1s) for the Brazilian market, subject to product approvals.

Strategic Importance

Neeraj Sharma, CEO & Managing Director of OneSource, emphasized the significance of this approval, stating, "This approval now enables OneSource to supply pharmaceutical products, especially DDCs, including GLP-1s manufactured at this site to the Brazilian market upon our customers getting their product approvals. It is a critical milestone for our company as Brazil is one of the biggest markets opening for generic Semaglutide in 2026."

About Unit 2

OneSource's Unit 2 is the company's flagship facility dedicated to manufacturing high-quality Biologics drug substances and finished products. The site specializes in producing Drug Device Combinations (DDC) and other injectable products, showcasing the company's capabilities in advanced pharmaceutical manufacturing.

Company Profile

OneSource Specialty Pharma Limited, formerly known as Stelis Biopharma Limited, positions itself as India's first specialty pharma Contract Development and Manufacturing Organization (CDMO). The company operates five state-of-the-art facilities, all approved by major regulatory bodies, including the USFDA and EU authorities. With a team of over 1,200 professionals, including 200+ techno-commercial experts, OneSource specializes in diverse dosage formats and advanced biologics platforms.

This latest regulatory approval further solidifies OneSource Specialty Pharma's position in the global pharmaceutical manufacturing landscape and sets the stage for potential growth in the Brazilian market, particularly in the emerging field of GLP-1 therapeutics.