Announcement: Listing of DXM as a Controlled Substance in China Since Jul 1st 2024

DXM to be listed as controlled substances in China

Dear Valued Customers and Partners,

We hope you’re doing well.

We are writing to inform you about an urgent and important regulatory update in the Chinese pharmaceutical industry, which will impact your import procedure, please note, and now it is already affecting the production and export of dextromethorphan (DXM).

On May 21st, 2024, our Chinese government announced that DXM will soon be classified as a Type II controlled substance. This decision is part of broader efforts to combat misuse and ensure public health and safety.

As a result, more restricted regulations will be imposed on the manufacture and sales of DXM.

DXM API manufacturers will need to apply for the Production Qualification from their local FDA before their manufacturing.

All the activities, including the R&D, purchase, mailing, transportation, and import/export of dextromethorphan will meet the requirements listed in the Medicines Control Act and Regulations on Narcotic Drugs and Psychotropic Substances since July 1st, 2024.

DXM to be regulated in China in 2024

Implications for Our Operations

As a leading exporter and supplier of active pharmaceutical ingredients (APIs) in China, we understand the potential impact this regulatory change may have on your operations. Here are some key points to consider:

1. Regulatory Compliance:

We are already working with our local Customs officials to ensure full compliance with the new regulations. This includes obtaining the required licenses and permits to continue the export of DXM under the new controlled substance classification.

2. Supply Chain Adjustments:

There may be temporary disruptions in your supply as we adapt to these changes. We will do our best to minimize the lead time and keep you informed of any necessary adjustments to delivery schedules or order quantities. Meanwhile, you will need to apply for an import permit from your MOH so you won’t have Customs issues when you handle the import clearance.

3. Collaboration with Authorities:

Our regulation team is in close communication with Chinese regulatory authorities to ensure a smooth transition. We are dedicated to meeting all legal requirements so we can continue the supply as soon as possible.

4. Customer Support:

We understand that this change will raise concerns and questions. Our customer support team is available to provide detailed information and help you in navigating this transition. Please do not hesitate to reach out to your sales representative for assistance.

Our Commitment to Quality and Safety

Our commitment to providing high-quality APIs remains unwavering. The reclassification of DXM as a controlled substance underscores the importance of responsible manufacturing and distribution practices. We are proud to adhere to these standards and continue to support the global pharmaceutical industry with integrity and excellence.

Looking Ahead

While this regulatory change presents us with challenges, it also reinforces the importance of our role in ensuring the safe and effective use of pharmaceutical ingredients. We are confident in our ability to adapt and continue to deliver the products and services you rely on.

Thank you for your continued trust and support in our business. Together, we can navigate this transition smoothly and continue to achieve success in our endeavors.

Best regards,

OCTAGONCHEM TEAM

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