GMP/FDA Approved APIs and New Molecules

APIs are our main products along with cosmetic raw materials. If you are also looking for a reliable supplier for bulk antibiotics and other active pharmaceutical ingredients certified by China FDA, such as AcarboseSpironolactoneCyclosporineVancomycin HydrochlorideTeicoplanin and Amphotericin B, you have come to the right place. Contact us now to try our free samples first.

Looking For Reliable Supplier of APIs? Contact Us Now!

GMP & FDA: Available

Standards: USP/EP

Sample for quality approval: Available

Standard Packing: 1kg/tin

USDMF: Available with NDC

Standards: USP/EP

Sample for quality approval: Available

Packing: 10kg/Carton

USDMF: Available

Standards: USP

Sample for quality approval: Available

Packing: 1kg/tin, 1bou/tin

USDMF: Available with NDC

Standards: USP

Sample for quality approval: Available

Standard Packing: 1kg/tin

3 Questions You Should Know Answers Before You Buy APIs

Before you plan to buy APIs, you get to know several things before you make the payment:

1. What purposes will be those APIs for?

#1. If you are a medicine manufacturer and you buy active ingredients for medicine production, GMP and DMF is a must for any MOH registration, ask your supplier if they have them. Also check if their APIs are exported and registered to other countries.

#2. If you are a researcher or scholar who needs to buy APIs and new molecules for your lab research, no GMP is needed for your import. But if the supplier has GMP, it is even better. In most cases, there are not GMP available for very new molecules. GMP approval takes years to process and tons of money. Normally API prices with GMP is double or triple of that without GMP, or even higher to 10 times.

#3. If you are a pharmacy owner and you need those APIs for your pharmacy compounding, what types of API source you should choose? Well let’s put it this way: if you are compounding formulations for humans, you should choose GMP source or your MOH registered ingredients, then you should have no issues on your customs clearance. If you are running a veterinary clinic and you are compounding for pets or animals, GMP is preferred but not mandatory. Just make sure of the purity and quality before you buy.

2. Do you know the regulations on those APIs from your Customs?

You better be familiar with your Customs regulations before you import, what are the import duties and taxes. If you are not quite sure, check them with your import brokers with detailed HS Code.

There are cases that some customers have imported restricted products unknowingly and get themselves into serious trouble such as lawsuits, punishment by fines. It is better avoid such unnecessary things.

3. Do you have a right API supplier to match your needs?

There are tons of chemical and pharmaceutcial suppliers selling all types of chemicals, all you need is your right supplier. By the word RIGHT, I mean your perfect match. I will give you an example to explain: if you are a heavy buyer and your yearly demand is in tens of millions of US Dollars for one single ingredient, your match would be the Number 1 Manufacturer.

If you are an extensive importer for all type of APIs and chemicals, your right supplier should be a trader who can handle all your purchases from many factories one by one. But all in all, your supplier has to be reliable, highly responsive, very responsible. Only in this way there won’t be any quality issues after the deal. Even there will be quality dispute, your exporter will help you to solve it properly. Either by refund after you ship goods back, or arrange you another shipment for free, or offer you discount to settle it. In case you don’t know how to find reliable chemical suppliers in China, please help to read one of our blogs on it.

Other new molecules you may need for Lab Research