OneSource Specialty Pharma announced on April 29, 2026, that its partner Dr. Reddy's Laboratories has received regulatory approval from Health Canada for a significant pharmaceutical product. The approval marks another milestone in the strategic partnership between the two companies in the specialty pharmaceutical sector.

Regulatory Approval Details

Dr. Reddy's Laboratories received a Notice of Compliance from Health Canada for Semaglutide Injection, which serves as a generic version of Ozempic®. The approval enables the commercialization of this important diabetes medication in the Canadian market.

Partnership and Manufacturing Role

OneSource serves as the Contract Development and Manufacturing Organization (CDMO) partner for this program, providing comprehensive manufacturing support. The company's role encompasses both scale-up operations and commercial manufacturing of the formulation.

The partnership leverages OneSource's US-FDA approved flagship manufacturing facility located in Bengaluru to ensure reliable and scalable commercial supply. This collaboration combines Dr. Reddy's expertise in peptide development with OneSource's specialized CDMO capabilities.

Management Commentary

Mr. Neeraj Sharma, CEO & MD of OneSource Specialty Pharma Limited, commented on the development: "We are pleased to announce that our partner Dr. Reddy's has received approval from Health Canada for Semaglutide Injection, a generic version of Ozempic®. This approval further strengthens our collaboration, combining Dr. Reddy's expertise in peptide development with OneSource's CDMO capabilities."

Company Profile

OneSource Specialty Pharma Limited operates as a pure-play specialty pharmaceutical CDMO, focusing on the development and manufacturing of complex pharmaceutical products. The company's portfolio includes:

• Biologics
• Drug-device combinations
• Sterile injectables
• Oral technologies (soft gelatine capsules)

The company has established itself as a trusted partner for global pharmaceutical companies seeking comprehensive, end-to-end solutions, backed by industry-leading manufacturing capacities and a strong compliance track record.

OneSource Specialty Pharma announced that its partner Orbicular Pharmaceutical Technologies, together with its US-based front-end partner, has secured tentative US Food and Drug Administration (FDA) approval for an Abbreviated New Drug Application (ANDA) for a generic version of Ozempic® (Semaglutide Injection). OneSource serves as the contract development and manufacturing organization (CDMO) partner for this complex peptide product.

Strategic Partnership Achievement

The milestone highlights a closely integrated development-to-submission approach between the partners. Orbicular led the product development and technical program for the complex peptide, while OneSource supported the initiative as the CDMO partner, providing comprehensive end-to-end manufacturing capabilities for the US market filing.

Management Commentary

Mr. Neeraj Sharma, CEO & MD of OneSource Specialty Pharma Limited, commented on the development: "We are pleased to announce that our partner Orbicular, along with its front-end partner (the ANDA holder), has received tentative approval for a generic version of Ozempic® (Semaglutide Injection). This milestone reflects Orbicular's scientific expertise and OneSource's CDMO capabilities, supported by our US-FDA approved manufacturing site."

Manufacturing and Supply Strategy

The collaboration is designed to ensure reliable commercial supply from OneSource's US-FDA approved flagship manufacturing site in Bangalore. This arrangement demonstrates the company's capability to support complex pharmaceutical products through its established manufacturing infrastructure and regulatory compliance framework.

Strategic Market Position

OneSource continues to strengthen its position as a global CDMO partner specializing in:

• Drug-device combinations
• Complex injectables
• Specialty pharmaceutical products

The company maintains strategic collaborations where it serves as the CDMO partner, supporting both manufacturing and commercial supply readiness for complex pharmaceutical products.

Company Overview

OneSource Specialty Pharma Limited focuses on development and manufacturing of complex pharmaceutical products including biologics, drug-device combinations, sterile injectables, and oral technologies. Orbicular operates as a partnership-driven, B2B specialty pharmaceutical company focused on designing, developing, and delivering complex generics and specialty pharmaceutical products.