Case Sharing One
Case-Melatonin
1、New drug，look for the API manufacturer.
2、Manufacturers are required to have production qualifications and documents.
3、EP/BP/USP standard are applicable.
4、Expect the register with DMF within 6month.
5、Declare according to the requirements of the object market.
Response from Hande
1、Communicate with customers timely to understand customer needs.
2、More research on the product:480+clinical trials;There are 2 DMF declarations in the US,no CN.In developing countries,no DMF of CN.
3、Understand the DMF filing requirements of developing countries;R&D,QA actively discuss;Come up with the client within a week and reach an agreement;Hande's reporting team,with years of global reporting experience,the DMF filing will be completed within 3M;3M earlier than expected.
4、Apply for DMF as purified 98%+,in progress.
Case Sharing Two
Case-Ecdysterone 1
1、Human drug clinical trials,EU and US mktg.
2、The previous supplier is not compliant,the new supplier needs to meet the EU GMP requirements,have full testing capabilities,be able to accept quality audits and cooperate with regulatory registration,and have stable supply capabilities.
Response from Hande
1、Communicate with customers timely to understand customer needs.
2、More research on the product:It is currently mainly used in veterinary drugs,dietary supplements,and high-end cosmetics;This is the first case of ecdysone applied to human medicine,Currently in Phase III CT.
3、None of the ecdysone suppliers currently on the market can satisfy quality research and compliance requirements required by customers.
4、Discussed internally;Accept 3 audits,remote 1 and onsite 2.
5、Now Hande is its qualified supplier.
Case Sharing Three
Case-Ecdysterone 2
1、Foreign Dietary Supplement Manufacturers.
2、Due to the question of the formula by consumers,ready to develop new recipes.
3、The requirements for the new formula are not particularly clear,need the support of manufacturer's data and testing.
Response from Hande
1、Communicate with customers timely to understand customer needs：20E needs to be clearly detected;Several other plant extract ingredients are required;The future formula is carried out according to the proportion of these plantings.
2、R&D,QA actively discuss;Come up with the client with detailed requirments.
3、Actively propose making recipes with multiple monomers,one-stop-shop solutions.
4、Hande has become a strong production backing for this customer.
Case Sharing Four
Case-Cepharanthine
1、As a potential new drug for the treatment of COVID-19,it is necessary to find suppliers who have technology,production conditions,and can do API research and declaration.
2、Need to cooperate with pilot test.
3、Need to provide relevant literature such as influencing factors.
Response from Hande
1、Communicate with customers timely to understand customer needs.
2、R&D,QA actively discuss;Come up with the client with detailed requirments.
3、Hande already had the Cepharanthine patent of separation and extraction methodof as early as 2011 Within the time that the client expects,complete the small test to the middle test,and provide literature support throughout the process.
4、Now Hande becomes its partner,and negotiating further in-depth cooperation.