Inke Achieves Aprepitant CEP and Salmeterol DMF – A Step Forward

At Inke, we are thrilled to share two significant achievements that underscore our ongoing commitment to regulatory excellence and the development of high-quality APIs. These milestones reinforce our position as a trusted partner in the global pharmaceutical landscape.

CEP Approval for Aprepitant

We are proud to announce that our Certificate of Suitability (CEP) for Aprepitant has been approved, marking a significant step in strengthening our presence in the European pharmaceutical market. This approval reflects Inke’s dedication to adhering to the highest quality standards and further expands our portfolio of CEP-approved APIs in Europe, now totaling 10 CEPs.

With over 25 years of expertise in regulatory compliance and API development, we continually innovate to meet the needs of our partners while upholding the stringent requirements of the global pharmaceutical industry.

DMF Approval for Salmeterol Xinafoate in China

In addition to the success in Europe, we are delighted to share that our Drug Master File (DMF) for Salmeterol Xinafoate has received approval from the Center for Drug Evaluation (CDE) in China.

This regulatory milestone solidifies our strategic presence in one of the most dynamic markets worldwide. With extensive experience navigating the regulatory landscape in China, Inke continues to deliver respiratory APIs of the highest caliber. The approval not only enhances our market footprint but also allows us to better serve our clients with tailored solutions that meet stringent regulatory standards.

Expanding Our API Portfolio

Both milestones reflect Inke’s unwavering dedication to producing innovative and compliant pharmaceutical solutions. Inke’s portfolio now includes a growing number of CEP-approved APIs in Europe and DMFs approved in China, enabling us to better serve diverse markets across the globe.

These recent approvals pave the way for new opportunities to collaborate with our partners, bringing innovative treatments to patients worldwide.

Stay tuned for more updates on our journey to delivering excellence in API development and manufacturing.

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