Dear k. Sanjay,
This is to reply to your below mail.
As we are the person who legally responsible for product produced in our plant, any product - commercial, trial, food or drug. We can not and will not produce any thing without pre-approval from Thai FDA.
This is for the safe of the company and all of us. If you know there will be a approval grant by when, please inform us and get it reconfirm from SRA, we can prepare to produce but will not produce it till then.
This is for your information.
And we also request you to follow all the formal or registered formula to register in other country. Any violent to the regulation will impact our GMP certification both Thai and other country.
k. Burin, k. Kanthapha, k. Narunate are authorized to re-check of these kind of legal compliance before produce any actual batch or trial batch.
Dear Sir,
I totally agree with your opinion sir.
Without having product approval from Thai FDA even we can't process registration in export markets since we need CFS which is a part of dossier.
We thought that samples can be produced having Por Yor 8 and it was known that food registration will available soo,n.
As experience produce capsules, packing and testing for COA (full cycle) takes around 3 months or more so prior request sent by us just to speed-up export registration. If its required to wait for approval in Thailand then surely we will wait.
Sir, we will be happy if our requests are discussed so we can update our submission timelines accordingly and inform BD.
Formula, we use latest revision only at time of submission to other market.
I will surely be a part of legal compliance.
regards,