EMERGE BIOSCIENCE PTE. LTD.: Biologic license for GARZULYS

EMERGE BIOSCIENCE PTE. LTD.: Biologic license for GARZULYS. Dated 104 days ago, it serves as a historical benchmark. Score 55/100. As of 2026-11-04, from openFDA device PMA and Drugs@FDA endpoints (U.S. Food and Drug Administration).

Data as of · Compiled by Zalwin from openFDA device PMA and Drugs@FDA endpoints (U.S. Food and Drug Administration)

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FieldValue
SponsorEMERGE BIOSCIENCE PTE. LTD.
ProductGARZULYS
Generic / ingredientINSULIN ASPART-FSAN
ApprovalBiologic license (BLA)
ApplicationBLA761497
Decided2026-07-24
Panel / classVIAL, MULTIDOSE
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  • Source agency: openFDA device PMA and Drugs@FDA endpoints (U.S. Food and Drug Administration)
  • Record date: 2026-07-24
  • Data refreshed: 2026-11-04
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LIVE PUBLIC DATA Source: openFDA device PMA and Drugs@FDA endpoints (U.S. Food and Drug Administration) · Last refreshed: Wed, 04 Nov 2026 06:06:18 GMT

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55 / 100 Score

  • A new product launch.

What is the FdaApprovalPulse record for EMERGE BIOSCIENCE PTE. LTD.?

The FDA approved GARZULYS (BLA761497) for EMERGE BIOSCIENCE PTE. LTD. on 2026-07-24: biologic license (BLA).

How does EMERGE BIOSCIENCE PTE. LTD. compare to other FdaApprovalPulse records?

It is 104 days old; check the official source for later updates before acting.

EMERGE BIOSCIENCE PTE. LTD. vs. top 3 peers

OrganizationRecord date
EMERGE BIOSCIENCE PTE. LTD.2026-07-24
AMGEN INC2026-10-22
SANDOZ INC2026-10-22
TEVA PHARMACEUTICALS, INC.2026-09-25

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FdaApprovalPulse: Biologic license (BLA)

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From openFDA (PMA and Drugs@FDA). openFDA can lag FDA decisions by days to weeks. Drug supplement types follow the FDA submission class (labeling and REMS, manufacturing/CMC, efficacy, other). Company and product level only. Verify on FDA databases before relying on an approval.

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