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Totally 83 FSMP Products have been Approved in China

from CIRS by

Updated on 24 Jun. 2022

Based on the relevant information released from the State Administration for Market Regulation (SAMR), the approved FSMP products in China have reached 83 up to now. In 2021, the number of newly registered FSMS reached 24, nutritionally incomplete food accounts for two-thirds of the 24 products and a total of 16 non-whole nutrition formula foods. The year of 2022 still starts with non-whole nutrition formula food. In the first half of the year, only two non-whole nutrition formula food were registered, among which "蓝沛" fat formula for special medical purpose is the first fat formula approved. The details are as follows.

Summary and Analysis of the Approved FSMP in China

Up to now, totally 83 FSMP products have been approved in China, including 54 domestic products and 29 foreign products. Among the 83 approved products, the dosage forms of 64 products are powder, and only 19 products are liquid.

In terms of product type, as shown in the figure below, 36 of them are infant formula for special medical purposes, 27 are nutritionally incomplete food, and 20 are nutritionally complete food. While specific nutritionally complete food have not been approved until now.

Note: Please refer to the appendix at the bottom of this article for details of the name, registered enterprise, registration number, validity period and other information of the 83 products (The information is subject to the official website).

China,Food,FSMP,Registration,Analysis,Medical,Special

Figure 1. The approved products in different categories

Relevant information are listed as below in table 1:

Table 1. 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

0-12 months

ALFARE/ NESTLE

Althera/NESTLE

ALFAMINO/ NESTLE

Partially hydrolyzed milk protein formula food

6

Eleva Care / ABBOTT

0-12 months

Similac / ABBOTT

EnfaGentlease / MEAD JOHNSON

优博敏佳/ SYNUTRA

NAN H.A./Nestle

舒力乐/ HANGZHOU

Similac / ABBOTT

Lactose free formula or low lactose formula food

10

Beingmate / HANGZHOU BEINGMAT

0-12 months

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

葆安素/Yeeper Dairy

澳优/ Ausnutria Dairy (China)

蓓舒消/ Heilongjiang Feihe

安尼尔/ Wissun International

Amino acid metabolism disorder formula food

1

Periflex / SHS

0-12 months

Premature or low birth weight infant formula food

12

Similac Neo / ABBOTT

0-12 months

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

甄而蔼/ Yeeper Dairy

Infant nutrition supplement

3

Similac HMFortifi/ ABBOTT

0-12 months

优博启能/ SYNUTRA

昔倍护/ HANGZHOU BEINGMATE

FSMP for people over the age of 12 months

Nutritionally complete foods

20

Pediasure / ABBOTT

1-10 year-old or above 10 years old

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

麦孚康全®/ Jilin Maifu

拜妥优/KWINS HESLTH

麦孚乐贝®/ Jilin Maifu

Specific nutritionally complete foods

0

NA

NA

Nutritionally incomplete foods

Electrolyte formula

11

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

恬能®/ Jiangsu Zhengda Fenghai

10-14 year-old

乐潼/ SUZHOU HENGRUI JIANKANG

1-10 year-old

君蓓乐维/GUANGDONG JUNJOY

Above 1 year-old

枢能/ YICHANG HUMANWELL

Above 18 year-old

若新/ Shandong Ruoyao

Above 18 year-old

卡捷®/ Jilin Maifu

Above 10 year-old

贝耶/ Shandong Ruoyao

10-14 year-old

特颐欣/ YICHANG HUMANWELL

Above 10 year-old

Nutrient components

14

伊能佳®/Zhejiang海正甦力康

Above 10 year-old

泉克/ Tibet DUOXIN

普柔汀®/Guanzhou EnterNutr

浦索®/ Jilin Maifu

诺葆平®/ Hebei Aisheng

葆棠华/ CSPC Zhongnuo Yaoye

益安喜®/Zhejiang Yiyuansu

西沁®/Jiangsu Xihong

冬泽定/Hunan Jiudian

蓝沛/Qingdao Languo

君蓓安/ GUANGDONG JUNJOY

Above 18 year-old

富安/Hainan DonglianChangfu

素乾®/ Jiangsu Zhengda Fenghai

冬泽速棠/ DAISY FSMP

Above 1 year-old

Thickening components

0

NA

NA

Liquid formula

0

NA

NA

Amino acid metabolism disorder formula

2

Periflex Ad./SHS

Above 10 year-old

Periflex®/SHS

There are totally 37 companies obtaining FSMP registration certificates, while among the 83 products, 11 of them have been developed by one company – Nestle. Moreover, there are 30 domestic companies obtaining FSMP certificate in China.

Information for each enterprise to register FSMP is as follows:

China,Food,FSMP,Registration,Analysis,Medical,Special

Figure 2. Quantity of approved FSMP products at different companies

Registration for the FSMP began in 2017. At the beginning, FSMP for infants under the age of 12 months accounted for a high proportion of registration, due to the perfect background of infant formula food enterprises, so the FSMP for infants under the age of 12 months still have great potential. The proportion of nutritionally incomplete foods reached 67% in 2021, much higher than other types of FSMP. In 2022, the first fat formula was approved, and the types of FSMP registration are gradually enriched.

The trend of registration types of the FSMP over the years is as follows:

China,Food,FSMP,Registration,Analysis,Medical,Special

Figure 3. Trend of FSMP registration types over the years

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

Annex 1. Detailed information of the 83 approved FSMP products

Table 2. The 83 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

56

Guangzhou EnterNutr

普柔汀®protein formula for special medical purpose

Powder

国食注字TY20200012

2025.10.27

57

Jilin Maifu Nutrition Technology co. LTD Changchun Branch

浦索®protein formula (powder) for special medical purpose

Powder

国食注字TY20200013

2025.12.20

58

Jilin Maifu Nutrition Technology co. LTD Changchun Branch

麦孚康全®nutritionally complete food (powder) for special medical purpose

Powder

国食注字TY20210001

2026.1.19

59

Beian Yeeper Dairy Co., Ltd

葆安素infant lactose free formula for special medical purpose

Powder

国食注字TY20210002

2026.4.11

60

Beian Yeeper Dairy Co., Ltd

甄而蔼low birth weight infant formula for special medical purpose

Powder

国食注字TY20210003

2026.4.11

61

Jiangsu Zhengda Fenghai

Pharmaceutical Co., Ltd

恬能®Electrolyte formula for special medical purposes

Liquid

国食注字TY20210004

2026.4.11

62

Ausnutria Dairy (China) Co., Ltd

稚舒infant lactose free formula for special medical purpose

Powder

国食注字TY20210005

2026.4.11

63

SUZHOU HENGRUI JIANKANG TECHNOLOGY CO., LTD

乐潼Electrolyte formula for special medical purposes

Liquid

国食注字TY20210006

2026.4.11

64

GUANGDONG JUNJOY MEDICAL NUTRITION CO. LTD

君蓓安carbohydrate formula for special medical purpose

Liquid

国食注字TY20210007

2026.4.11

65

Heilongjiang Feihe Dairy Co., Ltd

蓓舒消infant lactose free formula for special medical purpose

Powder

国食注字TY20210008

2026.4.11

66

Wissun International Nutrition Group Co., Ltd

安尼尔infant lactose free formula for special medical purpose

Powder

国食注字TY20210009

2026.4.11

67

Hainan DonglianChangfu Pharmaceutical Co., Ltd

富安特carbohydrate formula for special medical purpose

Liquid

国食注字TY20210010

2026.4.11

68

Jiangsu Zhengda Fenghai

Pharmaceutical Co., Ltd

素乾® carbohydrate formula for special medical purpose

Liquid

国食注字TY20210011

2026.4.11

69

GUANGDONG JUNJOY MEDICAL NUTRITION CO. LTD

君蓓乐维Electrolyte formula for special medical purposes

Liquid

国食注字TY20210012

2026.4.11

70

JIANGSU DAISY FSMP CO., LTD

冬泽速棠carbohydrate formula for special medical purpose

Powder

国食注字TY20210013

2026.4.11

71

Hebei Aisheng Technology Co., Ltd

诺葆平® protein formula for special medical purpose

Powder

国食注字TY20210014

2026.4.11

72

KWINS HEALTHY Pharmaceutical Jiangsu Co., LTD

拜妥优nutritionally complete food (powder) for special medical purpose

Powder

国食注字TY20210015

2026.6.6

73

YICHANG HUMANWELL FSMP Co. LTD

枢能Electrolyte formula for special medical purposes

Liquid

国食注字TY20210016

2026.8.17

74

CSPC Zhongnuo Pharmaceutical (Taizhou) Co. LTD

葆棠华carbohydrate formula for special medical purpose

Liquid

国食注字TY20210017

2026.8.17

75

Shandong Ruoyao FSMP Co. LTD

若新Electrolyte formula for special medical purposes

Powder

国食注字TY20210018

2026.8.17

76

Jilin Maifu Nutrition Technology co. LTD Changchun Branch

麦孚乐贝®nutritionally complete food (powder) for special medical purpose

Powder

国食注字TY20210019

2026.8.17

77

Zhejiang Yielement Food Co. LTD

益安喜®carbohydrate formula for special medical purpose

Liquid

国食注字TY20210020

2026.8.17

78

Jilin Maifu Nutrition Technology co. LTD Changchun Branch

卡捷®Electrolyte formula for special medical purposes

Powder

国食注字TY20210021

2026.8.17

79

Shandong Ruoyao FSMP Co. LTD

贝耶Electrolyte formula for special medical purposes

Liquid

国食注字TY20210022

2026.11.11

80

YICHANG HUMANWELL FSMP Co. LTD

特颐欣Electrolyte formula for special medical purposes

Liquid

国食注字TY20210023

2026.11.11

81

Jiangsu Xihong Biological Medicine Co. LTD

西沁® carbohydrate formula for special medical purpose

Liquid

国食注字TY20210024

2026.11.11

82

Qingdao Lanpei Nutrition health Technology Co., LTD

蓝沛fat formula for special medical purpose

Powder

国食注字TY20220001

2027.04.05

83

Hunan Jiudian Pharmaceutical Co. LTD

冬泽定protein formula for special medical purpose

Powder

国食注字TY20220001

2027.04.05

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

3. “澳优”(Ausnutria Dairy) changed its name to “稚舒” on December 28, 2021.

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