Import Suspensions for Chlorphenamine Maleate in 2020
After the coronavirus outbreak, the Indian government suspended the export of related APIs and medicines that can be used for coronavirus treatment.
They did this because they had to meet domestic demand first.
You know what happened later: the prices of APIs used for coronavirus have been soaring after India stopped exporting relevant APIs such as chloroquine phosphate and hydroxychloroquine sulfate.
Today, we will talk about China’s API import suspensions for foreign manufacturers.
There was a notice on the SFDA website for the Chlorphenamine Maleate API import suspension from Supriya Lifescience Ltd on March 17th, 2020. Please check the details below:
The State Food and Drug Administration recently conducted an overseas inspection of chlorphenamine maleate raw materials manufactured by Supriya Lifescience Ltd in India.
The details are as follows: Registration Number: H20171053; Dosage Form: API; Production Address: A-5/2, Lote Parshuram Industrial Area, MIDC, Tal-Khed, Dist-Ratnagiri, 415722, Maharashtra State, India.
After our investigation, we found that the manufacturer did not manage production processes in accordance with the requirements of pharmaceutical quality management specifications.
They also failed to verify some key processes that significantly impacted the quality of the drug substance.
In accordance with the relevant provisions of the Drug Administration Law of the People’s Republic of China, we have decided to suspend the import of chlorphenamine maleate from Supriya Lifescience, effective today.
Our drug regulatory authorities at Customs at each port have stopped issuing import clearance forms.
State Food And Drug Administration
March 17, 2020
It is not the first time the SFDA has suspended API imports from other countries.
Here, we list some APIs suspended for import to China in recent years.
Please take note if you are also buying from those API manufacturers.
Furosemide Import Suspended from AMRI India Pvt. Ltd in 2019
Announcement on Import Suspension of Furosemide API from AMRI India Pvt. Ltd. (2019 No. 23)
The China State Food and Drug Administration recently inspected AMRI India Pvt. Ltd.’s furosemide on-site production.
We found the following issues: AMRI changed the reaction conditions and the amounts of certain raw materials used in production, and, given the research situation, they failed to file a supplementary application with the Chinese drug regulatory authority.
AMRI failed to establish quality standards in accordance with the registration documents and submitted test results that were inconsistent with the registration standards. AMRI didn’t conduct adequate research and verification regarding changes to processing parameters and quality standards. Assessment of quality impact was insufficient.
The design of clean areas in production workshops did not adequately control pollution, cross-contamination, and confusion.
According to our comprehensive assessment, the production of furosemide in China did not comply with the “Good Manufacturing Practice for Drugs (Revised in 2010).”
We have decided that the drug regulatory authorities at various ports will suspend the issue of import clearance permits for this product from now on.
State Drug Administration
March 20, 2019
Loratadine import from Vasudha was suspended in 2019
Announcement on Suspension of Customs Clearance of Loratadine APIs from Fasuda Pharm, India (No. 22, 2019)
The China State Food and Drug Administration (FDA) recently conducted an on-site inspection of overseas Loratadine API production by Vasudha Pharma Chem Limited in India.
We found that Vasudha Pharma Chem Limited changed part of the production process, procedures, and equipment without reporting to the Chinese drug regulatory authority.
The research and verification of changes in process parameters and quality standards were insufficient.
According to our comprehensive evaluation, the production of Loratadine does not meet the requirements of China’s “Good Manufacturing Practice for Drugs (Revised in 2010)”. We have decided that, from now on, the drug regulatory authorities at various ports of entry will stop issuing import clearance certificates for this product.
State Drug Administration
March 20, 2019
End word
GMP is a rigorous practice worldwide. It matters to human health; sometimes it is a matter of life or death.
That’s why the SFDA is conducting more and more unannounced inspections of GMP factories in China.
Only in this way can the FDA identify more issues in pharmaceutical factories to minimize safety risks with medicines.
We will keep updating those SFDA alerts so everyone stays informed.
Disclaimer:
This content is for informational purposes only and is intended for business-to-business communication within the pharmaceutical industry. It is not intended as medical advice. The manufacture, import, and use of API must comply with all applicable laws and regulations in the relevant country or region.
This blog post is informational only and does not constitute medical advice.
Always consult a healthcare professional before starting any new medication or treatment.
