Official Statement: Biosativa Manufacturing Transition for the Brazilian Patients

As part of our long-term commitment to improving patient access while maintaining the highest quality standards, Biosativa is initiating a strategic transition of selected products to pharmaceutical compounding (magistral manufacturing) within Brazil, using imported pharmaceutical-grade active ingredients (APIs).

This initiative has been carefully planned over the past several months and represents an important milestone in Biosativa's commitment to the Brazilian medical cannabis market.

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Why we are making this transition?

For many years, the cost of treatment to Brazilian patientsremains one of the greatest barriers to accessing cannabinoid therapy.

By transferring the final manufacturing process to qualified Brazilian pharmaceutical facilities while continuing to source internationally qualified raw materials, Biosativa aims to:

• Reduce the overall treatment cost for patients.
• Eliminate international shipping expenses.
• Significantly shorten delivery times.
• Avoid lengthy importation procedures, which currently require approximately 30–40 days due to customs and regulatory processes.
• Improve treatment continuity by providing more consistent product availability.

Our objective is simple: make cannabinoid therapy more accessible without compromising the quality that physicians and patients have trusted for years.

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Quality remains unchanged

Although the final manufacturing process will now occur in Brazil, the quality standards that define Biosativa remain exactly the same.

Our formulations continue to be developed using pharmaceutical-grade imported cannabinoids from carefully selected suppliers with extensive experience serving regulated international markets, including Brazil.

Every stage of production continues to follow strict quality management procedures, including:

• Complete traceability of raw materials.
• Rigorous supplier qualification and auditing.
• Batch-by-batch quality control.
• Standardized manufacturing procedures.
• Comprehensive documentation throughout the production process.

Patients and healthcare professionals can expect the same formulation philosophy, therapeutic consistency, and manufacturing rigor that have always characterized Biosativa products.

Certified Brazilian Manufacturing

The Brazilian pharmaceutical compounding facilities participating in this transition operate under internationally recognized quality standards, including:

• cGMP (Current Good Manufacturing Practices)
• ISO 9001 Certified Quality Management System

These certifications reflect robust manufacturing controls, standardized operating procedures, continuous quality improvement, documented production processes, and comprehensive quality assurance systems.

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Commitment to product safety

The transition does not change Biosativa's commitment to product purity and safety.

All Biosativa cannabinoid products continue to be manufactured under the same quality principles:

• 100% natural terpenes.
• Free from heavy metals.
• Free from mycotoxins.
• Free from pesticides.
• Free from residual solvents.
• No animal testing.

Every production batch continues to undergo strict quality verification before being released.

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Supplier Qualification

Biosativa maintains rigorous standards for supplier selection and procurement.

Our active pharmaceutical ingredient suppliers have achieved the highest available ratings across all applicable quality certification categories and are continuously evaluated through our supplier qualification process.

We maintain strict control over:

• Supplier qualification.
• Raw material sourcing.
• Documentation.
• Traceability.
• Manufacturing consistency.
• Quality assurance.

This ensures that every Biosativa product continues to meet the high standards expected by physicians and patients.

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Products Included in the Initial Transition Phase

The following products will be included in the first phase of local manufacturing:

• Biosativa Full Light 50:1 – 1,120 mg / 10 mL
• Biosativa Full Spectrum 7,745 mg CBD:THC:CBN (0.2% THC) – 60 mL
• Biosativa 6.000mg Full Spectrum CBD:THC - 60ml 0,2% THC

Additional products may be incorporated in future phases following the successful completion of the transition program.

Transition Timeline

The migration will occur gradually to ensure uninterrupted patient care and complete manufacturing stability.

By September

Approximately 80% of Brazilian patients are expected to receive the locally manufactured formulations.

By December

100% of eligible patients are expected to have transitioned to the new manufacturing model.

Throughout this period, Biosativa will closely monitor manufacturing performance, product consistency, physician feedback, and patient experience to ensure a seamless transition.

Transparency and Patient Communication

Transparency remains one of Biosativa's core values.

Our official communication channel with patients continues to be Medicina In, which remains responsible for providing guidance, updates, educational information, and patient support throughout this transition.

We have complete confidence in the processes adopted, the quality management systems implemented, and our commitment to transparent communication with both physicians and patients.

Should patients have any questions regarding the transition, product availability, or treatment continuity, the Medicina In team will remain available to provide accurate and timely assistance.

Looking Ahead

This transition represents an important evolution in Biosativa's mission to expand access to high-quality cannabinoid therapies in Brazil.

By combining internationally sourced pharmaceutical-grade ingredients with certified Brazilian manufacturing, we are creating a more efficient supply chain while preserving the quality, safety, and therapeutic reliability that define the Biosativa brand.

Our commitment remains unchanged:

To provide safe, reliable, scientifically grounded cannabinoid medicines that improve patients' quality of life while making treatment increasingly accessible throughout Brazil.

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Regulatory Compliance and Quality Documentation

Every compounded medication must strictly comply with Brazilian pharmaceutical regulations established by the Brazilian Health Regulatory Agency (ANVISA), as well as all applicable sanitary legislation governing pharmaceutical compounding.

Licensed compounding pharmacies are subject to:

• Regular inspections by ANVISA and local health surveillance authorities.
• Compliance with Brazilian Good Compounding Practices.
• Mandatory quality management systems.
• Complete traceability of all pharmaceutical ingredients.
• Batch production records and documentation.
• Standard operating procedures (SOPs).
• Ongoing regulatory audits and periodic compliance assessments.
• CBD 98% Technical Dossier
• Cannabinoid Analysis

This regulatory model ensures that every medication is produced within a highly controlled pharmaceutical environment designed to guarantee patient safety, consistency, and product quality.

For Biosativa, this transition does not represent a reduction in quality standards—it represents a change in the regulatory pathway through which the final product is manufactured.

Our internal quality requirements remain unchanged, and we continue to apply rigorous standards for supplier qualification, imported pharmaceutical-grade ingredients, manufacturing oversight, and product consistency.

Patients and healthcare professionals can therefore remain confident that Biosativa products continue to meet the highest standards of quality, safety, and regulatory compliance throughout this transition.

Conclusion

However, Biosativa is continuously working to provide additional safety, confidence, and transparency to our patients in Brazil.

Over time, as the local manufacturing transition progresses, we intend to make additional optional documentation available to support physicians and patients with greater visibility into our quality standards. This may include supplementary technical documents, ingredient traceability records, supplier qualification information, quality summaries, and other supporting materials that reinforce the safety and consistency of our products.

Although these documents may not be legally required under the Brazilian compounding framework, Biosativa understands that cannabinoid therapy requires trust. For this reason, we are committed to going beyond the minimum regulatory requirements whenever possible, while respecting the applicable Brazilian pharmaceutical regulations and documentation standards.

Our goal is to provide patients, physicians, and partners with increasing transparency throughout this transition, ensuring that everyone involved feels informed, protected, and confident in the continuity of care.

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