What Japanese API makers expect from an API intermediate supplier in India

Japanese API makers rarely choose an API intermediate supplier on price alone. To become an API intermediate supplier Japan buyers trust, preparation counts more than a quote. In our experience, a buyer in Osaka or Tokyo can spend several months on documents and batch data before the first commercial order. Indian manufacturers who prepare for that early tend to build long partnerships. Those who don’t usually stop at the sample stage.

We put this together for the Procurement and Quality teams in Japan (including the trading companies that buy for the API makers).

Why Japan is turning to API sourcing in India

Japan is very much reliant on generics. The government has actively promoted generic use with the target of 80% of prescriptions by volume, though supply has at times not kept up with demand. A 2021 industry survey found that around 20% of the drugs on Japan’s national price list were experiencing supply issues. The majority of these were generics.

That shortage changed how Japanese companies buy. Many now want a second qualified source for key intermediates. An API intermediate supplier Japan can add as a backup is now in demand, and India is the obvious candidate for a China plus one approach. Trade rules help here too. Under the India-Japan Comprehensive Economic Partnership Agreement, many pharmaceutical products move between the two countries without customs duty.

API intermediate supplier Japan: 6 checks buyers use before approval

Every company has its own checklist. The six points below come up in almost every qualification we have seen, so a good API intermediate supplier prepares for all of them before the first meeting.

1. Impurity profile and API impurity control

Japanese quality teams read impurity data line by line. They want every known impurity named, with its limit and test method. Sometimes a customer asks for an extra purification step to meet a tighter limit. Treat that as a normal request. Many Japanese buyers will pay for the extra step, because a cleaner intermediate means fewer problems in their own API.

2. Batch-to-batch consistency

One good sample proves very little. Buyers usually ask for results from at least three consecutive batches to see whether purity holds steady.

3. Written change control

A new raw material source or a change to the route can affect the API maker’s own registration. The Pharmaceuticals and Medical Devices Agency (PMDA) runs Japan’s Master File system, and the API maker must report certain changes to it. For this reason, Japanese buyers expect an API intermediate supplier to give written notice well before any change.

4. Clear documents in plain English

Certificates of analysis and route summaries should be easy to read. Short sentences and simple tables also survive translation better when a colleague in Japan pastes them into a translation tool.

5. GMP systems and audit readiness

Most Japanese buyers audit a new site before approval, in person or remotely. They check batch records, deviation handling and equipment cleaning, and they ask who signs off each batch. Our quality systems cover testing at every stage, from incoming raw materials to the finished batch, with quality assurance reviewing the documents.

6. Capacity for bulk pharmaceutical intermediates

Buyers also want an API intermediate supplier Japan can grow with. A plant that handles 5 kg easily but struggles at 500 kg is a risk. We run 30 KL of total reactor capacity, with stainless steel and glass-lined reactors from 50 litres to 3 KL. So we can move from trial quantities to bulk pharmaceutical intermediates without changing sites.

How trading companies fit into API sourcing from India

Trading houses take a large slice of the imported pharma materials market in Japan. They act as the conduit between the supplier and the end user and will often be the ones who maintain the commercial relationship. An Indian API intermediate supplier Japan works with will therefore typically answer to two people. The trading house will want a reliable supply and clear commercial terms. The API manufacturer will want the technical data. One well-prepared document pack will in fact satisfy both.

Intermediates for API manufacturers in Japan: what we supply

PYG Lifesciences is an API intermediates manufacturer based in Gujarat, India. Our range includes sartan intermediates such as Bromo OTBN (CAS 114772-54-2) and BCFI (CAS 83857-96-9). API makers use them to produce losartan and related blood pressure medicines. We also make Glibenclamide Sulfonamide (CAS 16673-34-0) for anti-diabetic APIs.

If you’re comparing pharma intermediates from India then we’ll answer any technical questions prior to price discussion.

Looking for an API intermediate supplier Japan can qualify?

Are you qualifying an API intermediate supplier for Sartan or anti-diabetic intermediates? Please send us your spec and annual volume to info@pyglifesciences.com and we’ll get back to you with the technical data and an indicative lead time.