Brazil opens doors to OneSource’s GLP-1 drugs as Bengaluru plant gets ANVISA nod

How OneSource Specialty Pharma’s ANVISA certification strengthens its global CDMO ambitions

OneSource Specialty Pharma Limited, formerly known as Stelis Biopharma Limited, has achieved a crucial regulatory milestone with the Good Manufacturing Practices (GMP) certification from ANVISA, the Brazilian Health Regulatory Agency, for its flagship Unit 2 facility in Bengaluru. This development enhances the company’s international compliance standing and unlocks a major commercial pathway into Latin America’s largest pharmaceutical market. The certification was granted following a successful inspection conducted between November 18 and 22, 2024, underscoring OneSource’s robust quality systems and operational readiness.

As Brazil prepares to introduce generic Semaglutide to its national formulary in 2026, OneSource’s readiness to supply drug-device combinations (DDCs), including GLP-1-based injectables, marks a strategic inflection point. The company’s Unit 2 facility, which focuses on high-quality biologics and injectable drug-device products, is now certified to supply products to Brazilian partners pending individual product approvals. This move further extends the reach of OneSource’s contract development and manufacturing organisation (CDMO) model, particularly in the high-growth biologics segment.

Why is ANVISA certification a turning point in OneSource’s expansion strategy?

Certification from ANVISA is not just regulatory recognition—it is also a critical commercial enabler for pharmaceutical manufacturers looking to enter the Brazilian market. For OneSource Specialty Pharma, the approval allows its flagship Unit 2 facility to supply GLP-1 injectables to Brazil at a time when the global market for these therapies is surging, driven by rising rates of type 2 diabetes and obesity.

Neeraj Sharma, Chief Executive Officer and Managing Director of OneSource, highlighted the strategic significance of this development, noting that Brazil represents one of the largest upcoming opportunities for generic Semaglutide. With increasing attention on cost-effective diabetes care, CDMOs that can meet regulatory standards while delivering advanced formulations stand to gain substantially in Latin America.

This GMP nod also distinguishes OneSource from other Indian CDMOs seeking entry into regulated South American markets. Brazil remains the fifth-largest pharmaceutical market globally by volume and a gateway to broader Latin American penetration. With this certification, OneSource not only gains access to Brazil but also strengthens its regulatory credentials with other regional authorities such as Mexico’s COFEPRIS and Colombia’s INVIMA.

What makes Unit 2 pivotal for biologics manufacturing and regulatory alignment?

Unit 2, located in Bengaluru, serves as the cornerstone of OneSource’s manufacturing infrastructure. Dedicated to biologics drug substances, complex injectables, and advanced drug-device combinations, it is emblematic of the company’s pivot towards higher-value CDMO solutions. The facility is now certified by ANVISA in addition to being approved by other leading global regulators such as the US Food and Drug Administration and European agencies.

This comprehensive compliance profile is especially important for DDCs and GLP-1 analogues, which require meticulous adherence to quality, sterility, and traceability protocols. Biologic drugs are inherently complex to manufacture, and their integration into device-based delivery formats further increases the regulatory burden. OneSource’s ability to secure certifications across such technically challenging platforms positions it as a reliable global partner for pharmaceutical companies seeking rapid and compliant market entry.

Historically, manufacturing capabilities in India have been heavily skewed towards generics. However, OneSource’s investment in biologics and high-end manufacturing reflects an industry shift toward value-added services. The certification of Unit 2 serves as a signal to international clients that the company is equipped to handle scale, complexity, and compliance—all essential for next-generation therapeutics.

How does this move align with growing demand for GLP-1 drugs and CDMO services?

OneSource’s regulatory win aligns with a broader surge in global demand for GLP-1 receptor agonists like Semaglutide. Originally developed for type 2 diabetes, GLP-1 analogues are now being repurposed for obesity, cardiovascular risk reduction, and metabolic syndrome management. As a result, pharmaceutical companies worldwide are seeking CDMO partners with capabilities in sterile injectables and biologics to meet demand forecasts.

The CDMO sector is also undergoing rapid transformation, with more companies outsourcing end-to-end manufacturing and development to focus on innovation and commercial strategy. This outsourcing trend is particularly pronounced for biologics and combination products, where the capital intensity and technical expertise required are substantial. OneSource’s Unit 2, now validated by ANVISA, is well-positioned to support these outsourcing demands through flexible capacity, scalable production, and regulatory alignment.

For Brazil, the approval also means accelerated access to cost-effective alternatives as healthcare systems seek to reduce spending while managing the rise of chronic conditions. OneSource’s entry into this market with certified capabilities could support drug accessibility, affordability, and patient outcomes.

What are the company’s broader infrastructure strengths and leadership focus?

OneSource Specialty Pharma operates five high-specification facilities, all approved by international regulatory agencies. With a workforce exceeding 1,200 professionals, including over 200 techno-commercial specialists, the company brings together scientific, regulatory, and commercial expertise under one umbrella. These capabilities have allowed it to evolve from a manufacturing service provider to a global CDMO offering integrated development-to-commercialisation solutions.

Under the leadership of Neeraj Sharma, OneSource’s transformation includes not just expanded regulatory approvals but also strategic rebranding and portfolio diversification. Its renaming from Stelis Biopharma Limited to OneSource Specialty Pharma in 2024 signalled a deeper focus on end-to-end pharma services, biologics, and high-value formulations. The ANVISA certification is the first major validation of that strategy under the new brand identity.

What is the stock market sentiment toward OneSource following this milestone?

As of April 11, 2025, shares of OneSource Specialty Pharma Limited (BSE: 544292, NSE: ONESOURCE) closed at ₹1,504.20, marking a 4.35% decline from the previous day’s close of ₹1,553.35. The stock has been volatile, trading between a 52-week high of ₹1,800 and a low of ₹1,209.95. Despite this fluctuation, the company remains in focus for investors tracking pharma CDMOs with global aspirations.

Financially, OneSource reported a net loss of ₹391.17 crore for the fiscal year 2024, on revenues of ₹171.92 crore. The company’s earnings per share (EPS) stood at -₹21.55, while the price-to-earnings ratio (P/E) remained negative at -68.67, indicating near-term profitability challenges. However, long-term investor interest is being driven by its growing regulatory footprint, the high-margin potential of biologics, and emerging market access such as Brazil.

Given these dynamics, the investment sentiment around the stock is cautiously optimistic. The recent ANVISA approval could lead to revenue uptick and margin improvements as the company begins servicing Latin American clients. For now, a ‘Hold’ recommendation appears prudent, with investors advised to monitor regulatory developments, product filings, and partner agreements in Brazil and other regions.

What lies ahead as OneSource leverages its ANVISA approval?

Looking forward, OneSource is likely to deepen its presence in the Latin American market, targeting partnerships with pharmaceutical companies seeking to register and distribute generic Semaglutide and other DDCs. The company may also pursue additional certifications to expand into markets such as Mexico, Argentina, and Colombia. These strategic expansions would not only diversify its client base but also insulate its revenue model from region-specific regulatory or demand shocks.

Furthermore, the ANVISA certification offers a platform for expanding its biologics CDMO offering beyond Brazil. In an industry increasingly driven by biosimilars, personalised medicine, and device-enabled delivery systems, OneSource is equipped to provide regulatory-compliant manufacturing at scale. This capability, validated by global regulators, will be key to attracting long-term contracts and boosting investor confidence.