aboutUs

About us
Company introduction
Business philosophy
Our Service
Service process
Company achievement
Global market
Latest product requirements

Who are we ？

Ningbo Fengrui Fine Chemical Ltd is a foreign trade company specializing in the export of pharmaceutical raw materials andrious fine che vamicals.

Our core business is to undertake thorough market research in China and raise high-quality pharmaceutical raw materials and fine chemical products entrusted by overseas pharmaceutical enterprises. To help China's outstanding pharmaceutical enterprises effectively enter the overseas pharmaceutical market.

Among them, the business oriented to the Japanese market is to effectively utilize the function and prominent influence of KOA SHOJI CO.,LTD., and to act as the agent for its business activities in China for a long time, accumulating rich knowledge and experience. We hope to promote the mutually beneficial development of China and foreign markets through our own efforts and become an ideal partner for Chinese pharmaceutical companies to enter the Japanese generic drug market.

What we can do ？

Through the exchange of information with Japanese agency company, our company timely grasps the needs of customers and seeks suppliers to meet the requirements of customers in the domestic market. At the same time, we provide methods for domestic enterprises to expand their business in Japan, carry out various consulting activities together with our agents on patents, drug licensing regulations and quality management, etc., and serve Chinese enterprises to enter the Japanese generic drug market.

Since April 1st, 2005, four regulations related to API (pharmaceutical active ingredients) have been introduced in Japan after the implementation of the revised pharmaceutical act. Namely: foreign manufacturer accreditation system (referred to as AFM accreditation), MF registration system, GMP compliance inspection system and GQP agreement (good quality management standard) system.

With rich experience, our company can provide extensive and thoughtful support to domestic enterprises in the Japanese market.

Honest and trustworthy, professional and efficient, keep improving, create value for customers. Determined to contribute to the mutually beneficial development of Chinese and foreign pharmaceutical and chemical markets through our own efforts.

Be honest and trustworthy

Honesty is value. We meet the needs of our customers with professional knowledge and clear service concept, and do what we can.

Professional and efficient

Over the past ten years, we have focused on the pharmaceutical raw material market and accumulated rich experience through in-depth cooperation with customers, which enables us to serve our customers more professionally. There are effective working procedures in every link from market research to product formation and sales to ensure efficient operation and service quality.

Keep improving

We strive to provide customers with high quality products, and carry out this spirit in the daily work, become the company's action policy. To this end, we constantly improve our internal workflow and train our staff so that we can better discover the needs of customers, ensure customer and staff satisfaction, and ensure efficient work.

Create value for customers

We shouldn't be microphones, we shouldn't be porters. We want to be in front of the customer first, do in front of the customer, use their own advantages to raise high quality products for the customer, stable supply and reasonable price.

AFM DMF GMP GQP

What is "AFM" ？

'AFM' is short for 'Accreditation of Foreign Manufacturers', which is usually called' Foreign manufacturer's Accreditation '.Some manufacturers of pharmaceuticals, quasi-drugs and medical apparatus and instruments abroad in Japan need to Accredited Foreign manufacturers (MHLW), according to ARTICLE 13-3 of pharmaceutical law, if they want to produce some relevant products to the Japanese market. Domestic companies need to be recognized by the ministry in the same way. To put it simply, AFM accreditation is for manufacturing sites, similar to the way we obtain drug manufacturing licenses. As far as API business is concerned, AFM that it is the first drug regulatory barrier to enter the Japanese market. Any pharmaceutical manufacturer wishing to export API or intermediates to the Japanese market needs to obtain AFM certification first, and has obtained a "company code" and "business code".

When do the registration of AFM, will the Japanese authorities go to the factory for on-site inspection?

in principle, the AFM needs inspectors from the ministry of labor, health and welfare should also be sent to the factory for on-site inspection to confirm the production of hardware facilities and software systems. However, for a variety of reasons, when determining AFM and updating AFM, it is generally file checking.

What documents should be submitted to Japanese authorities when applying for AFM accreditation?

the information required by AFM is very simple and does not take much time to prepare. Generally speaking, the following information is required:
Information submitted by AFM:
(1) application for Japanese version (prepared by Japanese agent and signed by Chinese manufacturer)
(2) the medical examination certificate or self-declaration from the representative of production site
(3) resumes of the Head of production and the Head of quality
(4) product catalog and process flow chart
(5) Form I of facilities and buildings (including company plan, workshop plan, finishing and packing plan, QC plan, warehouse plan, and corresponding area.)
(6) questionnaire about production sites
(7) organization chart
(8) scanned copy of production license and English translation
(9) GMP certificate issued by the local government
(10) the translator's statement
(11) letter of authorization

The validity period of AFM?

the AFM is valid for 5 years and needs to be renewed every 5 years. The information submitted for update is approximately the same as that initially identified.

Is AFM identification required for each product?

of course not. Not every product needs to be identified by AFM separately. The identification of AFM is for the production site. Once the Japanese official permits are obtained, the AFM certificate is obtained. The AFM identification number may be cited for products of the same category produced within the premises without the need to repeat the identification. Moreover, Japanese regulations do not allow repeated identification of the same production site

What is the price for registration of AFM?

in terms of AFM accreditation, there are five situations involving fees: new accreditation of AFM (application for AFM accreditation for the first time), renewal of AFM (renewal of AFM accreditation every five years), increase/change of categories of accreditation of AFM, and certificate issuance. The cost varies depending on whether it is a site inspection or a document inspection. The fees determined by AFM are as follows:

Foreign manufacturer recognized inspection fee classification fee (JPY)	MHLW	PMDA
New AFM (on site)	90000	133300
New AFM (file)	90000	58100
AFM update (on site)	19400	64600
AFM update (file)	90000	39700
Additional categories identified (on site)	90000	64600
Additional categories identified (file)	90000	39700
Changes in identified categories (on site)	19400	64600
Changes in identified categories (file)	90000	133300
Issue of AFM certification	15700	——
Reissue of AFM certificate	15700	——

In general, based on the business cooperation between the two sides, our company and the Japanese agent KOA SHOJI carry out AFM identification and AFM maintenance for our partners for free.

Commissioned by overseas pharmaceutical companies to conduct thorough market research in China and raise high quality raw materials and fine chemical products.

Help customers to grasp the market demand in time, looking for products to meet customer requirements in China. For example, for original drugs whose patent expires in 2015, foreign customers often start to look for excellent active ingredients 4-5 years before the patent expires. We can provide comprehensive market research services to help customers understand Chinese manufacturers and their products.

To ensure a steady supply of products, to provide high quality products to meet the customer's highest quality requirements.

1. we will screen out the suppliers with the best quality through cooperation with the external testing institutions.
2. assist customers to cooperate with suppliers with international level of drug regulatory management.
3. promote smooth communication and pleasant cooperation between custom -ers and suppliers.

To help China's outstanding pharmaceutical enterprises effectively enter the overseas pharmaceutical market.

1. provide accurate foreign market information and customer demand infor -mation.
2. provide consulting services on drug license laws and regulations in the target market
3. help maintain drug license regulations.
4. help manufacturers understand foreign target markets and improve prod -uct value.

5.our suppliers.

Our company was founded in 2002, is a foreign trade company which specializes in high-end market pharmaceutical raw materials.

Since the establishment of our company , we have been focusing on the Japanese market and engaged in business activities in the Japan for more than ten years, with quite rich market experience and business foundation. Through years of careful operation in the Japanese market, our company has steadily won the wide trust of Japanese customers, and has a proud performance.

After years of hard work, our company has 13 Accreditation by Foreign manufacturers in Japan (excluding those that have been registered or transferred). J-DMF registered 38 (valid, excluding deregistration).

Ningbo Fengrui has successfully helped outstanding domestic pharmaceutical companies enter the Japanese market, providing quality products and expanding market share.

AFM certification is a qualification certification of whether the production facilities and equipment of overseas pharmaceutical manufacturers are qualified for pharmaceutical production from Japan. Japan's domestic manufacturers License will be produced in a similar way.

NO.	Product Name	CAS No.	standard
1	Timclol Maleate	26921-17-5	CP/USP
2	Amantadine Hydrochloride	665-66-7	CP/USP
3	Amrinone	60719-84-8	CP/USP
4	Flecainide Acetate	54143-56-5	CP/USP