API Import Suspensions for Chlorphenamine Maleate in 2020
After the coronavirus breakout, The Indian Government has suspended the export of related APIs and medicines that can be used for coronavirus treatment. They did this because they must cater to domestic demands first.
You know what happens later, the prices of APIs used for coronavirus have been soaring after India stops the export of relevant APIs such as Chloroquine Phosphate, hydroxychloroquine Sulfate.
But today we will talk about China’s API Import Suspensions of foreign manufacturers.
There was notice from SFDA website for the Chlorphenamine Maleate API Import Suspensions from Supriya Lifescience Ltd on March 17th, 2020, please check the details as below:
The State Food and Drug Administration recently ran an inspection overseas on chlorphenamine maleate, manufactured by Supriya Lifescience Ltd from India with details 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 the manufacturer didn’t manage the production processes by the requirements of pharmaceutical production quality management specifications. Also, they failed to verify some key processes that had significant impacts on the quality of the drug substance.
According to 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 starting today. Our drug regulatory authorities at the Customs from each port have stopped to issue the import clearance forms for it.
State Food And Drug Administration
March 17, 2020
This is not the first time the SFDA has supended the API import from other countries. Here we list some of the apis suspended for import to China in recent years. If you are also buying from those API manufacturers, you should take notice.
Announcement on Import Suspension of Furosemide API from AMRI India Pvt. Ltd.. (2019 No. 23)
Recently, the China State Food and Drug Administration organized an on-site inspection of the Ferusemide production of AMRI India Pvt. Ltd.
We found the following issues: AMRI changed the reaction conditions and the input amount of some raw materials during the production process, and they failed to file a supplementary application to the Chinese drug regulatory authority based on the research situation. AMRI failed to set up quality standards following the registration docs, and passed some testing results inconsistent with registration standards; AMRI didn’t perform adequate research and verification for the changes in processing parameters and quality standards. Assessment of quality impact was insufficient; There was not adequate control over pollution, cross-contamination, and confusion from the design and management of clean areas in production workshops. According to our comprehensive assessment, the production of furosemide did not comply with “Good Manufacturing Practice for Drugs (Revised in 2010)” in China. We have decided that from now on, the drug regulatory authorities at various ports will suspend the issue of import clearance permits for this product.
State Drug Administration
March 20, 2019
Announcement on Suspension of Customs Clearance of Loratadine APIs from Fasuda Pharm, India (No. 22, 2019)
Recently, the China State Food and Drug Administration (SFDA) organized an on-site inspection of the Loratadine API production overseas from Vasudha Pharm Chem Limited in India. We found that Fasuda 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 import ports will stop issuing of import clearance certificates for this product.
State Drug Administration
March 20, 2019
GMP is a very strict practice everywhere in the world, it matters to human health, sometimes it is life or death. That’s why there are more and more unnoticed inspections from SFDA to GMP factories in China.
Only in this way can FDA find more issues in pharmaceutical factories, so our medicine safety issues can be minimized to the most.
We will keep on updating those alerts from SFDA so everyone can pay attention.