APIs (Active Pharmaceutical Ingredients)

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

1. Purposes For The Imported APIs?

#1. You will need a GMP and DMF for any MOH registration if you manufacture medicine and import active pharmaceutical ingredients for use in medicine production.

Ask your pharmaceutical suppliers if they have those.

Also, check if their APIs have been exported to and registered in other countries.

#2. If you are a researcher or scholar who needs to purchase APIs and new molecules for laboratory research, you won’t require GMP for import clearance.

However, if the supplier has GMP certification, it is even better.

In most cases, GMP is not available for new molecules because obtaining GMP approval requires years of processing and incurs high costs.

Typically, API prices with GMP are double or triple those without GMP, or even 10 times as high.

#3. If you are a pharmacy owner and need those APIs for your pharmacy compounding, which API sources should you choose?

To put it this way, if you are compounding formulations for humans, it is advisable to use GMP APIs or APIs from your MOH-registered suppliers, which should ensure smooth customs clearance.

If you run a veterinary clinic and compound medications for pets, GMP is preferred but not mandatory.

Ensure the product is pure and of good quality before purchasing.

2. What Are The Customs Regulations On Those APIs?

Before importing, familiarize yourself with your country’s customs regulations, including the applicable duties and taxes, as well as the import permits required to release the goods from Customs.

If you are unsure about any of these, please consult your import brokers for a detailed HS Code.

There are cases where customers have unknowingly imported restricted products, resulting in serious trouble, such as lawsuits and heavy fines.

It is better to avoid such unnecessary troubles by doing the work properly before you start.

3. Do You Have the Right API Suppliers For Your Needs?

Many chemical and pharmaceutical suppliers offer a wide range of chemicals; all you need is the right supplier.

By the word RIGHT, I mean your perfect match.

I will explain an example: if you are a heavy buyer and your yearly demand for one ingredient is in the tens of millions of US Dollars, your perfect match would be the number-one Manufacturer.

If you import APIs and chemicals extensively, your ideal supplier should be a trader who can handle small-volume purchases from multiple factories.

However, overall, your supplier must be reliable, highly responsive, and very responsible.

Only in this way will there not be any quality issues after the deal.

Even if there is a quality dispute, your exporter will help you resolve it properly. Either refund you after you ship the goods back, arrange a free second shipment, or offer a discount to settle the matter.

If you need help finding fornecedores confiáveis de produtos químicos na China, please read one of our blogs.