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Syngene — Bengaluru

Bengaluru, India · CDMO

This is a record of what regulators published, not a rating.

Site facts

Company
Syngene
Name(s) in FDA data
Syngene International Ltd.
FEI number(s)
3003600340 (present in FDA Data Dashboard records for this name and city)
Location (as in FDA data)
Bengaluru, India
Records matched
5 FDA inspections
Most recent FDA inspection in dataset
20 Feb 2025 — NAI

Capabilities (from the company's website)

  • Sterile fill-finish
    …le October Edition of ‘Putting Science to Work’ Newsletter is Now Live From ADC design to fill-finish, plus what we heard at CPHI Milan: why early decisions shape success. Read the Newsletter…
  • Biologics drug substance
    …gene's new biologics facility in the U.S. New site to increase Syngene’s total single-use bioreactor capacity to 50,000 Liters Click here to know more Applications Are Now Open for the Follo…
  • Small molecule
    …lue for customers, employees and shareholders. Read the Press Release Fewer Iterations in Small Molecule Design AI-powered discovery to optimize potency, selectivity, and safety earlier Read the…
  • ADCs & bioconjugates
    …Read the Article October Edition of ‘Putting Science to Work’ Newsletter is Now Live From ADC design to fill-finish, plus what we heard at CPHI Milan: why early decisions shape succes…
  • Clinical trial supply & packaging
    …More More Manufacturing Our Manufacturing services include cGMP-compliant facilities for clinical supplies, registration batches… More More Dedicated Centers Our Dedicated Centers offer dedicat…

Taken from a company-level page; the company does not publish a separate page for this site, so tags may describe the wider organisation. Source: https://www.syngeneintl.com/, checked 16 Oct 2026. Quoted text shows the wording each tag is based on.

Regulatory timeline

Newest first. Each entry links to the published source. Inspection classifications: NAI = no action indicated, VAI = voluntary action indicated, OAI = official action indicated (FDA definitions). Posted 483 citations are FDA's short summaries, not the full Form 483.

  1. 20 Feb 2025
    FDA inspection FDA inspection classified NAI

    No Action Indicated (NAI). Product type(s): Drugs, Veterinary. Project area(s): Drug Quality Assurance; Monitoring of Marketed Animal Drugs, Feed, and Devices; Pre-Approval Eval. of Animal Drugs and Food Additives.

    Source: FDA Data Dashboard – Inspections (FEI 3003600340, inspection ID 1267516)

  2. 15 Nov 2022
    FDA inspection FDA inspection classified NAI

    No Action Indicated (NAI). Product type(s): Veterinary. Project area(s): Pre-Approval Eval. of Animal Drugs and Food Additives.

    Source: FDA Data Dashboard – Inspections (FEI 3003600340, inspection ID 1193108)

  3. 21 Aug 2019
    FDA inspection FDA inspection classified NAI

    No Action Indicated (NAI). Product type(s): Drugs. Project area(s): Drug Quality Assurance.

    Source: FDA Data Dashboard – Inspections (FEI 3003600340, inspection ID 1103377)

  4. 11 Jul 2014
    FDA inspection FDA inspection classified NAI

    No Action Indicated (NAI). Product type(s): Drugs. Project area(s): Drug Quality Assurance.

    Source: FDA Data Dashboard – Inspections (FEI 3003600340, inspection ID 890834)

  5. 18 Sep 2013
    FDA inspection FDA inspection classified NAI

    No Action Indicated (NAI). Product type(s): Drugs. Project area(s): Drug Quality Assurance.

    Source: FDA Data Dashboard – Inspections (FEI 3003600340, inspection ID 849300)

This is a record of what regulators published, not a rating. Absence of a record here does not mean no record exists; see methodology for what we check and how records are matched.