Component Formula Approved--Totally 55 FSMP Approved in China

Updated on 27 Oct. 2020

Based on the relevant information released from the State Administration for Market Regulation (SAMR), the approved FSMP products in China have reached 55 until now. It shall be noticed that, component formula (categorized as nutritionally incomplete food) has finally been approved, which are one protein formula and one carbohydrate formula. Details are as follows.

Summary and Analysis of the Approved FSMP in China

Until now, totally 55 FSMP products have been approved in China. Among them, 26 products are domestic products while the remaining are foreign products. Relevant information are listed as below in table 1:

Table 1. The 55 approved FSMP products

S.N.

Applicant

Product name

Dosage form

Certificate number

Expiry date

1

SHS INTERNATIONAL LTD

Neocate infant amino acid formula (powder) for special medical purpose

Powder

国食注字TY20175001

2022.11.19

2

ABBOTT LABORATORIES S.A.

Similac infant partially hydrolyzed milk protein formula (powder) for special medical purpose

Powder

国食注字TY20175002

2022.11.19

3

ABBOTT LABORATORIES S.A.

Eleva Care infant partially hydrolyzed milk protein formula (powder) for special medical purpose

Powder

国食注字TY20175003

2022.11.19

4

HANGZHOU BEINGMATE MATERNAL AND CHILD NUTRITION CO., LTD.

Beingmate infant lactose free formula for special medical purpose

Powder

国食注字TY20180001

2023.2.12

5

SHS INTERNATIONAL LTD

Periflex infant phenylketonuria formula (powder) for special medical purpose

Powder

国食注字TY20185001

2023.2.26

6

MEAD JOHNSON B.V.

EnfaGentlease infant partially hydrolyzed milk protein formula (powder) for special medical purpose

Powder

国食注字TY20185002

2023.3.19

7

ABBOTT NUTRITION, ABBOTT LABORATORIES

Similac Neo preterm/low birth weight infant formula for special medical purpose

Liquid

国食注字TY20185003

2023.6.25

8

ABBOTT NUTRITION, ABBOTT LABORATORIES

Similac Gro preterm/low birth weight infant formula for special medical purpose

Liquid

国食注字TY20185004

2023.6.25

9

MEAD JOHNSON B.V.

Enfagrow infant lactose free formula (powder) for special medical purpose

Powder

国食注字TY20185005

2023.7.22

10

NESTLE NEDERLAND B.V.

早瑞能恩 preterm/low birth weight infant formula for special medical purpose

Powder

国食注字TY20185006

2023.7.22

11

SUZHOU HENGRUI JIANKANG TECHNOLOGY CO., LTD

乐赋 electrolyte formula for special medical purpose

Liquid

国食注字TY20180002

2023.7.22

12

SUZHOU HENGRUI JIANKANG TECHNOLOGY CO., LTD

乐棠electrolyte formula for special medical purpose

Liquid

国食注字TY20180003

2023.7.22

13

ABBOTT MANUFACTURING SINGAPORE PRIVATE LIMITED

Pediasure nutritionally complete food for special medical purpose

Powder

国食注字TY20185007

2023.8.2

14

MEAD JOHNSON B.V.

Enfapro preterm/low birth weight infant formula (powder) for special medical purpose

Powder

国食注字TY20185008

2023.8.13

15

SYNUTRA INTERNATIONAL INC

优博敏佳partially hydrolyzed milk protein formula for special medical purpose

Powder

国食注字TY20180004

2023.8.13

16

SYNUTRA INTERNATIONAL INC

优博安能preterm/low birth weight infant formula for special medical purpose

Powder

国食注字TY20180005

2023.8.13

17

ABBOTT LABORATORIES S.A.

ABBOTT Similac preterm/low birth weight infant formula (powder) for special medical purpose

Powder

国食注字TY20185009

2023.10.7

18

MILUPA GMBH

Nutricia preterm/low birth weight infant formula for special medical purpose

Powder

国食注字TY20185010

2023.10.7

19

SHS INTERNATIONAL LTD

Periflex Ad. phenylketonuria formula (powder) for special medical purpose

Powder

国食注字TY20185011

2023.12.19

20

NESTLE NEDERLAND B.V.

ALFARE infant extensively hydrolyzed milk protein formula for special medical purpose

Powder

国食注字TY20185012

2023.12.19

21

ABBOTT NUTRITION

Similac HMFortifi infant nutrition supplement for special medical purpose

Powder

国食注字TY20185013

2023.12.19

22

Nestlé Deutschland AG

早启能恩 preterm/low birth weight infant formula for special medical purpose

Powder

国食注字TY20195001

2024.01.23

23

Nestlé Deutschland AG

NAN H.A. partially hydrolyzed milk protein formula for special medical purpose

Powder

国食注字TY20195002

2024.01.23

24

NESTLE NEDERLAND B.V.

安儿宁能恩 infant lactose free formula for special medical purpose

Powder

国食注字TY20195003

2024.01.23

25

Nestle Health Science China

佳膳佳立畅nutritionally complete food for special medical purpose

Liquid

国食注字TY20190001

2024.6.10

26

SYNUTRA INTERNATIONAL INC

优博启能infant nutrition supplement for special medical purpose

Powder

国食注字TY20190002

2024.6.13

27

Nestlé Suisse SA, factory Konolfingen

PEPTAMEN JUNIOR nutritionally complete food for special medical purpose

Powder

国食注字TY20195004

2024.6.13

28

Du’erbote Yili Dairy Co. LTD

伊利®欣活® nutritionally complete food (powder) for special medical purpose

Powder

国食注字TY20190003

2024.6.18

29

HANGZHOU BEINGMATE MATERNAL AND CHILD NUTRITION CO., LTD.

贝新尔preterm/low birth weight infant formula for special medical purpose

Powder

国食注字TY20190004

2024.6.18

30

ABBOTT MANUFACTURING SINGAPORE PRIVATE LIMITED

ENSURE COMPLETE® nutritionally complete food for special medical purpose

Powder

国食注字TY20195005

2024.6.26

31

Nestlé Suisse SA, factory Konolfingen

NUTREN JUNIOR nutritionally complete food for special medical purpose

Powder

国食注字TY20195006

2024.6.26

32

Nestlé Suisse SA, factory Konolfingen

NUTREN OPTIMUM nutritionally complete food for special medical purpose

Powder

国食注字TY20195007

2024.6.26

33

Maeil Dairies Co., Ltd

爱思诺赋儿嘉infant lactose free formula for special medical purpose

Powder

国食注字TY20195009

2024.6.27

34

Maeil Dairies Co., Ltd

爱思诺晨而慧preterm/low birth weight infant formula for special medical purpose

Powder

国食注字TY20195008

2024.6.27

35

HANGZHOU BEINGMATE MATERNAL AND CHILD NUTRITION CO., LTD.

昔倍护infant nutrition supplement for special medical purpose

Powder

国食注字TY20190005

2024.7.29

36

Tianjin Aumix Dairy Co. LTD

力诺康宁infant lactose free formula for special medical purpose

Powder

国食注字TY20190006

2024.10.13

37

SYNUTRA INTERNATIONAL INC

优博启瑞nutritionally complete food for special medical purpose

Powder

国食注字TY20190008

2024.10.21

38

Nantong Richen Bioengineering Co. LTD

力存优太nutritionally complete food for special medical purpose

Powder

国食注字TY20190007

2024.10.21

39

Nestle Nederland B.V.

Althera infant extensively hydrolyzed milk protein formula for special medical purpose

Powder

国食注字TY20195010

2024.10.21

40

Wyeth Nutritionals Ireland Ltd.

Wyeth® ULTIMA® 蔼而嘉preterm/low birth weight infant formula for special medical purpose

Powder

国食注字TY20195011

2024.10.29

41

SYNUTRA INTERNATIONAL INC

优博瑞安infant lactose free formula for special medical purpose

Powder

国食注字TY20190009

2024.11.24

42

Jilin Maifu Nutrition Technology co. LTD Changchun Branch

麦孚畅清® nutritionally complete food (powder) for special medical purpose

Powder

国食注字TY20190010

2024.12.11

43

SHS International Ltd

Periflex® amino acid metabolism disorder formula for special medical purpose

Powder

国食注字TY20195012

2024.12.24

44

AusNuotore

爱优诺优益力 nutritionally complete food for special medical purpose

Powder

国食注字TY20200001

2025.2.27

45

AusNuotore

爱优诺优康力 nutritionally complete food for special medical purpose

Powder

国食注字TY20200002

2025.2.27

46

Harbin Ballansat Clinical Nutrition Co., Ltd

唯卡能® nutritionally complete food (powder) for special medical purpose

Powder

国食注字TY20200003

2025.3.23

47

Guangdong Junjoy Medical Nutrition Co., Ltd

君蓓全 nutritionally complete food for special medical purpose

Powder

国食注字TY20200004

2025.3.27

48

SUZHOU HENGRUI JIANKANG TECHNOLOGY CO., LTD

希瑞臻nutritionally complete food for special medical purpose

Powder

国食注字TY20200005

2025.4.21

49

HANGZHOU BEINGMATE MATERNAL AND CHILD NUTRITION CO., LTD.

舒力乐 infant partially hydrolyzed milk protein formula for special medical purpose

Powder

国食注字TY20200006

2025.5.13

50

YABAO Pharmaceutical Group Co., Ltd

唯源素® nutritionally complete food (powder) for special medical purpose

Powder

国食注字TY20200007

2025.5.13

51

Nestle Nederland B.V.

ALFAMINO infant amino acid formula for special medical purpose

Powder

国食注字TY20205001

2025.5.15

52

Tibet DUOXIN HEALTH CO., LTD.

艾诺利Electrolyte formula for special medical purposes

Liquid

国食注字TY20200008

2025.8.9

53

Zhejiang 海正甦力康Biotechnology Co. LTD

伊能佳® protein formula for special medical purpose

Powder

国食注字TY20200009

2025.8.27

54

Tibet DUOXIN HEALTH CO., LTD.

泉克 carbohydrate formula for special medical purpose

Liquid

国食注字TY20200010

2025.8.27

55

SUZHOU HENGRUI JIANKANG TECHNOLOGY CO., LTD

希瑞怡® nutritionally complete food (powder) for special medical purpose

Powder

国食注字TY20200011

2025.9.28

Note: 1. the general names in the table are updated according to the Notice on the Adjustment of General Name of FSMP

2. "舒乐加" (SUZHOU HENGRUI JIANKANG) changed its name to "乐赋" on August 23, 2019;YILI “焕初” changed its name to“伊利®欣活®”on December 31, 2019

As demonstrated above, among the 55 approved products, the dosage forms of 48 products are powder, and only 7 products are liquid.

There are totally 20 companies obtaining FSMP registration certificates, while among the 55 products, 11 of them have been developed by one company – Nestle. Moreover, there are 13 domestic companies obtaining FSMP certificate in China.

Special,Medical,FSMP,Registration,Formula,Nestle,Analysis

Figure 1. Quantity of approved FSMP products at different companies

Among the 55 products, in terms of product type, as shown in the figure below, 31 of them are infant formula for special medical purposes, 7 are nutritionally incomplete food, and 17 are nutritionally complete food. While specific nutritionally complete food have not been approved until now.

Special,Medical,FSMP,Registration,Formula,Nestle,Analysis

Figure 2. The approved products in different categories

The detailed information are shown in table 2.

Table 2. Summary of the categories/types of the approved products

Categories/types

Amount being approved

Product/Company

Adapted population

FSMP for infants under the age of 12 months 

Extensively hydrolyzed milk protein formula or amino acid-based formula food

4

Neocate / SHS

ALFARE/ NESTLE

Althera/NESTLE

ALFAMINO/ NESTLE

0-12 months

Partially hydrolyzed milk protein formula food

6

Eleva Care / ABBOTT

Similac / ABBOTT

EnfaGentlease / MEAD JOHNSON

优博敏佳/ SYNUTRA

NAN H.A./Nestle

舒力乐/ HANGZHOU BEINGMATE

0-12 months

Lactose free formula or low lactose formula food

6

Beingmate / HANGZHOU BEINGMATE

Enfagrow / MEAD JOHNSON

安儿宁能恩/ Nestle

爱思诺赋儿嘉/ Maeil Dairies

力诺康宁/Tianjin Aumix

优博瑞安/ SYNUTRA

0-12 months

Amino acid metabolism disorder formula food

1

Periflex / SHS

0-12 months

Premature or low birth weight infant formula food

11

Similac Neo / ABBOTT

Similac Gro / ABBOTT

早瑞能恩/ NESTLE

Enfapro/ MEAD JOHNSON

优博安能/ SYNUTRA

Similac/ ABBOTT

Nutricia/ MILUPA

早启能恩/ Nestle

爱思诺晨而慧/ Maeil Dairies

贝新尔/ HANGZHOU BEINGMATE

Wyeth® ULTIMA® 蔼而嘉/Wyeth

0-12 months

Infant nutrition supplement

3

Similac HMFortifi/ ABBOTT

优博启能/ SYNUTRA

昔倍护/ HANGZHOU BEINGMATE

0-12 months

FSMP for people over the age of 12 months

Nutritionally complete foods

17

Pediasure / ABBOTT

佳膳佳立畅/Nestle

小佰太能/Nestle

伊利®欣活®/Yili

ENSURE COMPLETE®/Abbott

NUTREN JUNIOR /Nestle

NUTREN OPTIMUM /Nestle

优博启瑞/ SYNUTRA

力存优太/Nantong Richen

麦孚畅清®/Jilin Maifu

爱优诺优益力/ AusNuotore

爱优诺优康力/ AusNuotore

唯卡能®/Harbin Ballansat

君蓓全/Guangdong Junjoy

希瑞臻/ SUZHOU HENGRUI JIANKANG

唯源素®/YABAO

希瑞怡®/ SUZHOU HENGRUI JIANKANG

1-10 year-old or above 10 years old

Specific nutritionally complete foods

0

NA

NA

Nutritionally incomplete foods

Electrolyte formula

3

乐赋/ SUZHOU HENGRUI JIANKANG

Above 10 year-old

乐棠/ SUZHOU HENGRUI JIANKANG

Above 18 year-old

艾诺利/Tibet DUOXIN

Above 10 year-old

Nutrient components

2

伊能佳®/Zhejiang海正甦力康

泉克/ Tibet DUOXIN

Above 10 year-old

Thickening components

0

NA

NA

Liquid formula

0

NA

NA

Amino acid metabolism disorder formula

2

Periflex Ad./SHS

Periflex®/SHS

Above 10 year-old

The above information is analysis associated with the current situation of FSMP registration in China. Click to know more about FSMP registration requirements in China.

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