OneSource Specialty Pharma’s Bengaluru Unit 2 achieves ANVISA GMP Certification, a major milestone that affirms the company’s adherence to world-class pharmaceutical manufacturing standards. This significant achievement, granted by ANVISA (Agência Nacional de Vigilância Sanitária) — Brazil’s National Health Surveillance Agency — empowers OneSource to expand its global footprint, especially in regulated markets across Latin America. Known for its specialized focus on biologics, complex injectables, and innovative drug-device combinations, this certification signals OneSource’s readiness to serve international demand with the highest standards of quality and compliance.
World-Class Facility at Doddaballapura, Bengaluru
The certified Bengaluru Unit 2 facility is located in Doddaballapura and sprawls over 450,000 sq. ft., housing cutting-edge infrastructure specifically designed for the development and production of biologics, sterile injectables, and drug-device combination products. This world-class unit incorporates microbial and mammalian cell-based platforms and has integrated capabilities covering process development, analytical testing, and full-scale manufacturing.
OneSource Specialty Pharma’s Bengaluru Unit 2 achieves ANVISA GMP certification for this state-of-the-art facility, enabling the production of 40 million cartridges, 28 million prefilled syringes, and 4 million vials annually. With its sterile capabilities and advanced automation, it is tailored to meet the demands of both domestic and international clients in complex therapy segments.
Integrated Quality Systems and Regulatory Compliance
What truly sets this facility apart is its stringent adherence to quality and compliance. Onsite analytical and microbiology laboratories support in-process, release, and stability testing with precision. Environmental controls, automated packaging with 100% visual inspection, and contamination prevention systems all comply with global regulatory frameworks.
The Unit 2 facility is not only ANVISA-certified but also built in line with USFDA and EUGMP expectations, making it future-ready for multifaceted regulatory approvals. The facility aligns with global supply chain strategies, and by including the link to its innovative product solutions (View Our Products), OneSource enables potential partners to explore a range of pharmaceutical advancements and offerings.
Strategic Collaborations Empowering Innovation
In its pursuit of constant innovation, OneSource has forged a strategic licensing agreement with Bhami’s Research Laboratory (BRL), acquiring access to BRL’s HILOPRO technology. This advanced formulation allows the subcutaneous delivery of high-concentration biologics, making treatments more patient-friendly and less invasive.
Such technological synergy expands OneSource’s capability in biosimilars and biologics, helping it stay ahead in the ever-evolving global pharmaceutical landscape. The use of high-viscosity reduction formulations will drastically improve patient outcomes, especially in oncology, rheumatology, and immunotherapy segments.
Demonstrated Track Record in Regulatory Audits
OneSource has consistently proven its commitment to quality by successfully completing 138 inspections by major global regulatory agencies. Its BLD facility in Bengaluru recently received an Establishment Inspection Report (EIR) with a ‘Voluntary Action Indicated’ (VAI) status from the USFDA, demonstrating its solid compliance credentials. This reinforces customer trust and regulatory acceptance across the United States, Europe, and Latin America.
Such regulatory consistency further justifies why OneSource Specialty Pharma’s Bengaluru Unit 2 achieves ANVISA GMP certification, a development celebrated both within the organization and among its global clientele.
Sustainability and Social Responsibility: Core to OneSource’s DNA
Sustainability is another cornerstone of OneSource’s business model. The company has a clear vision of transitioning 90% of its energy needs to renewable sources by 2026 and reaching full energy sustainability by 2030. Initiatives include the use of LPG in boiler systems to reduce emissions and the adoption of water recycling processes to minimize environmental impact.
Beyond green manufacturing, OneSource actively contributes to the surrounding communities, especially in Doddaballapura. Educational support, healthcare outreach, and infrastructure improvement initiatives reflect OneSource’s deep commitment to holistic development and ethical business practices.
Expansion and Global Market Penetration
Receiving ANVISA GMP certification is a pivotal moment in OneSource’s plan to penetrate Brazil and other Latin American markets. The certification not only enables the export of biologics and sterile injectables to Brazil but also elevates the company’s credibility across regulated markets in South America.
This achievement opens up new horizons in global pharmaceutical exports and contract manufacturing services. As pharmaceutical companies worldwide look for trusted partners with proven quality systems, OneSource now becomes a compelling CDMO choice, especially for biologics and sterile manufacturing.
Moreover, OneSource Specialty Pharma’s Bengaluru Unit 2 achieves ANVISA GMP certification just as the global demand for high-quality biologics and sterile injectables is skyrocketing. According to a report by GlobalData, the global CDMO market is expected to grow at a CAGR of 6.5% over the next five years, with sterile injectables and biologics taking the lead. This validates OneSource’s strategic direction and positions it favorably for long-term success.
Conclusion
With this milestone, OneSource Specialty Pharma fortifies its vision of becoming a world-class pharmaceutical solutions provider. The certification underscores its reliability, technological superiority, and future-readiness. By combining advanced biologics capabilities, regulatory strength, sustainability, and community focus, the company offers a truly differentiated value proposition.
OneSource Specialty Pharma’s Bengaluru Unit 2 achieving ANVISA GMP certification is not just a recognition — it’s a gateway to global excellence, innovation, and positive patient impact. This achievement reflects the company’s unwavering pursuit of quality, and it stands as a beacon for Indian pharmaceutical companies aiming to shine on the global stage.
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