Announcement: Listing of DXM as a Controlled Substance in China Since Jul 1st 2024
Dear Valued Customers and Partners,
We hope you’re doing well.
We are writing to inform you about an urgent and essential regulatory update in the Chinese pharmaceutical industry.
Please note that this update will impact your import procedure, which is already affecting the production and export of dextromethorphan (DXM).
On May 21st, 2024, the 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, CDE will impose stricter regulations on DXM’s manufacturing and sales.
DXM API manufacturers must apply for the Production Qualification from their local FDA before manufacturing.
Since July 1st, 2024, all dextromethorphan activities, including R&D, purchase, mailing, transportation, and import/export, will comply with the Medicines Control Act and Regulations on Narcotic Drugs and Psychotropic Substances requirements.
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, including obtaining the required licenses and permits to continue exporting DXM under the new controlled substance classification.
2. Supply Chain Adjustments:
Your supply may have temporary disruptions as we adapt to these changes.
We will do our best to minimize the lead time and inform you 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 closely communicating with Chinese regulatory authorities to ensure a smooth transition. We are dedicated to meeting all legal requirements to resume supply immediately.
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 navigate this transition. Please do not hesitate to contact your sales representative for assistance.
Our Commitment to Quality and Safety
Our commitment to providing high-quality APIs remains unwavering. DXM’s reclassification 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
