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Wyeth Registers First FSMP in China

Nestle’s 10th FSMP and Wyeth’s 1st FSMP were approved by SAMR. As of Nov. 12, 2019, 40 foods for special medical purposes have been registered of which 27 are overseas products.

5 foods for special medical purposes (FSMP) obtained registration certificates according to 3 notices regarding registration decisions issued by Chinese regulators in October and November respectively.[1] They are:

SNApplication Acceptance No.ApplicantProductCountry
1国食注申TY20180041天津澳斯乳业有限公司力诺康宁Infant lactose free formulaChina
2国食注申TY20180033圣元营养食品有限公司优博启瑞Nutritionally complete formulaChina
3国食注申TY20180008南通励成生物工程有限公司力存优太Nutritionally complete formulaChina
4国食注申TY20190035Nestle Nederland B.V.肽敏舒Infant extensively hydrolyzed milk protein formulaNetherlands
5国食注申TY20190010Wyeth Nutritionals Ireland Ltd.惠氏®铂臻®蔼而嘉Infant premature/low birth weight formulaIreland

The approval of these 5 FSMPs brings the total number of registered products to 40. The overall distribution is as follows.

By country of origin

Country of originNumber of registered products
China13
Netherlands7
UK3
Switzerland3
Germany3
Spain3
USA3
Singapore2
S. Korea2
Ireland1

By product segment

Type (Target Group)FormulaRegistered products
Infant FSMPPremature or low birth weight infant formula food11
Partially hydrolyzed milk protein formula food5
Infant lactose free formula food or low lactose formula food5
Extensively hydrolyzed milk protein formula or amino acid-based formula food2
Infant nutrition supplement3
Amino acid metabolism disorder formula food2
Other FSMPSpecial full nutritional formula food0
Nutritionally incomplete formula food3
Nutritionally complete formula food9

By manufacturer/brand 

Manufacturer/brandNumber of registered products
Nestlé10
Abbott8
Danone4
Synutra4
Mead Johnson3
Beingmate3
Maeil Dairies2
Suzhou Hengrui (苏州恒瑞)2
Yili (伊利)1
Wyeth1
Nantong Richen (南通励成)1
Aumix Dairy(天津澳斯乳业)1

For the full list of registered FSMPs, please go to ChemLinked f-list: Foods for Special Medical Purpose Registration in China.

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