FlaggedRx

Indian manufacturers on FDA import alert (live)

100 Indian firms currently on FDA Import Alert 66-40 · checked Jul 05, 2026

What Import Alert 66-40 means

Import Alert 66-40 is FDA's “Red List” of foreign drug firms placed under Detention Without Physical Examination (DWPE) for current-good-manufacturing-practice (cGMP) problems. Once a firm is listed, its shipments are held at the US border by default — an operational block that takes effect immediately, typically weeks before any public warning letter (we measured one gap at 48 days). Source: FDA accessdata.fda.gov.

India is our differentiator: alongside FDA's 66-40, FlaggedRx also monitors CDSCO NSQ and spurious-drug alerts — the domestic Indian signal most US-facing tools miss. A Supplier Risk Check resolves one manufacturer across FDA, MHRA, and CDSCO, through name and transliteration variance.

Newly added (last 90 days) — 4

The signal nobody ranking on this term publishes: firms placed recently, the ones your qualification file hasn't caught up to yet.

Indian firms on the Red List (searchable)

Firms with an active 66-40 flag. Absence is not an all-clear — a firm may be listed under another legal name or a subsidiary.
100 firms shown
FirmCountryPlacement date
Aadivighnesh Chem PVT. LTD.INDIA2014-05-05
Aarti Drugs LtdINDIA2015-03-23
AKRON FORMULATIONS INDIA PRIVATE LIMITEDINDIA2024-11-26
Alchymars ICM SM Private LimitedINDIA2026-05-19
Almon Healthcare Private LimitedINDIA2026-06-09
Amanta Healthcare Ltd.INDIA2014-03-12
Amsal Chem Pvt. Ltd.INDIA2013-04-11
Anicare Pharmaceuticals Pvt Ltd.INDIA2023-07-12
Aspen Biopharma Labs Pvt., Ltd.INDIA2025-01-15
Astral SteriTech Private Ltd.INDIA2023-10-26
B. JAIN PHARMACEUTICALS PRIVATE LIMITEDINDIA2019-01-17
Badrivishal Chemicals & PharmaceuticalsINDIA2016-12-19
BE Pharmaceuticals Private Ltd.INDIA2015-08-21
Bhargava Phytolab Private LimitedINDIA2024-11-15
Biotek IndiaINDIA2021-03-10
Brassica Pharma Private LtdINDIA2024-01-30
Canton Laboratories Private Ltd.INDIA2014-04-10
Centrient Pharmaceuticals India Private LimitedINDIA2022-11-21
Centurion Laboratories Private LimitedINDIA2019-03-11
CMHP Private LimitedINDIA2023-03-06
Contacare Ophthalmics & DiagnosticsINDIA2019-02-20
Dabur India LimitedINDIA2026-06-05
Emcure Pharmaceuticals LimitedINDIA2015-07-13
ESSND GLOBALINDIA2020-01-31
Fleming Laboratories LimitedINDIA2011-04-11
Flowchem Pharma Private LimitedINDIA2026-01-22
Gland Chemicals Private LimitedINDIA2018-08-01
Glenmark Pharmaceuticals LimitedINDIA2022-10-25
Glint Cosmetics Private LtdINDIA2019-04-17
Global Calcium Pvt. LimitedINDIA2024-12-20
Global Pharma Healthcare Private LimitedINDIA2023-01-03
Health Biotech LimitedINDIA2018-04-03
Healwell Homeo Private LimitedINDIA2025-03-31
Indiana Chem-PortINDIA2021-12-13
Intas Pharmaceuticals LimitedINDIA2023-11-14
Jagsonpal Pharmaceuticals Ltd.INDIA2025-01-17
JHS SVENDGAARD LABORATORIES LTDINDIA2020-01-02
JT Cosmetics & Chemicals Pvt Ltd.INDIA2018-06-11
Kamud Drugs Pvt. Ltd.INDIA2013-07-10
KENIL HEALTHCARE PRIVATE LIMITEDINDIA2025-04-04
Kilitch Healthcare India LimitedINDIA2023-10-23
Kim Chemicals Private Ltd.INDIA2017-08-21
Konduskar Laboratories Pvt LtdINDIA2013-07-10
Kopalle Pharma Chemicals Pvt Ltd.INDIA2018-06-22
Lake ChemicalsINDIA2020-01-27
Lake Chemicals Private LimitedINDIA2020-01-27
Lake Chemicals Pvt LtdINDIA2020-01-27
Lake Chemicals Pvt Ltd.INDIA2020-01-27
Liv Long Nutraceuticals LimitedINDIA2021-06-16
Livlong NutraceuticalsINDIA2021-06-16
M/S Jagsonpal Exports India Pvt. Ltd.INDIA2025-01-17
Madhu Instruments Private LimitedINDIA2023-05-31
Mahendra ChemicalsINDIA2017-08-25
Mayon's Pharmaceuticals Private LtdINDIA2020-07-13
MMC HEALTHCARE LTD.INDIA2024-09-06
Mylan Laboratories LimitedINDIA2024-12-19
NEW WORLD HEALTHCARE PRIVATE LIMITEDINDIA2020-03-02
Nivedita Chemicals Pvt. Ltd.INDIA2011-11-23
OMNI LENS PVT. LTD.INDIA2024-09-27
ORCHID LIFESCIENCESINDIA2023-03-23
Pan Drugs LimitedINDIA2015-12-08
Pan Drugs Ltd.INDIA2015-05-05
Patcos Cosmetics (India) Private LimitedINDIA2023-11-17
Polydrug Laboratories Pvt. Ltd.INDIA2015-09-11
Reine LifescienceINDIA2018-03-30
RPG Life Sciences LimitedINDIA2013-06-11
Rxhomeo Private LimitedINDIA2019-05-22
Sal PharmaINDIA2017-02-15
Seema InternationalINDIA2025-09-18
Sentiss Pharma Private Ltd.INDIA2013-06-20
Shankar PharmacyINDIA2021-06-16
Shilpa Medicare LimitedINDIA2021-02-16
Shimoga ChemicalsINDIA2026-06-02
Smruthi Organics LimitedINDIA2013-06-03
Sri Krishna Pharmaceuticals LimitedINDIA2015-08-13
Srikem Laboratories Private Ltd.INDIA2016-07-06
Stericon Pharma Pvt. Ltd.INDIA2011-01-13
Suhan AerosolINDIA2023-03-30
Sun Pharmaceutical Industries (prev. Ranbaxy)INDIA2009-09-10
Sun Pharmaceutical Industries Limited - KarkhadiINDIA2014-03-12
Sun Pharmaceutical Industries Ltd.INDIA2022-12-07
Tyche Industries Ltd.INDIA2025-01-02
Unexo Life Sciences Private LimitedINDIA2024-10-22
Unique ChemicalsINDIA2013-06-28
Vega Life SciencesINDIA2020-04-14
Vignesh Life Science Pvt LtdINDIA2013-06-28
Vignesh Life Science Pvt., LtdINDIA2013-06-28
Vikshara Trading & Investment Ltd.INDIA2017-02-08
Vipor Chemicals Private Ltd.INDIA2018-07-11
Vista Pharmaceuticals LimitedINDIA2018-05-22
Vital Laboratories Pvt LtdINDIA2019-05-07
Vital Laboratories Pvt Ltd Plant IINDIA2019-05-07
Vital Laboratories Pvt Ltd Plant IIINDIA2019-05-07
Vital Laboratories Pvt. Ltd.INDIA2019-05-07
Windlas Healthcare Private LimitedINDIA2020-01-21
Wizcure Pharmaa Private LimitedINDIA2025-12-23
Wockhardt LimitedINDIA2013-05-22
Wockhardt, Ltd.INDIA2016-08-05
Xylo Chem IndustriesINDIA2024-01-16
Yag Mag Labs Private LimitedINDIA2011-09-13

Common questions

What happens when a supplier is placed on 66-40?
Its drug shipments to the US are detained at the border without physical exam. The firm must demonstrate to FDA that the underlying cGMP problems are resolved to be removed. This is a supply-continuity and qualification risk for anyone sourcing from that site.
How does a firm get removed from the Red List?
By petitioning FDA with evidence the deficiencies are corrected (often after a re-inspection). Removal timelines vary widely; a listing can persist for months or years.
Does a firm's absence mean it's cleared?
No. Absence from this list is not an all-clear. The same firm may appear under another legal name or a subsidiary, the list changes continuously, and 66-40 is one of several signals. Run a Supplier Risk Check to check a specific supplier across FDA, MHRA, and CDSCO with cross-regulator identity resolution.
Monitoring a supplier base? FlaggedRx watches your API and CMO suppliers across FDA, MHRA, and CDSCO and emails you the moment one lands on 66-40 — weeks before the warning letter. Run a free Supplier Risk Check → · Pricing