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U.S. Department of Health and Human Services

GRAS Notices

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GRN No. 960

Hypromellose acetate succinate

Intended Use: Intended for use as an enteric coating agent, carrier for solid dispersions, and an enteric agent in tablets/caplets, granules, pellets, and capsules (including gel caps, pills, soft gels, and vegi caps) at levels ranging from 5% to 80% of the final product weight.
Basis: Scientific procedures
Notifier: Shin-Etsu Chemical Co., Ltd.
Notifier Address: YBP Technical Center, 134 Godo-cho
Hodogaya-ku, Yokohama 240-0005
GRAS Notice (releasable information): GRN 960 with amendments (in PDF) (6.6 MB)
Date of closure: Dec 21, 2021
FDA's Letter: FDA has no questions (126 kB)