India Pharma USFDA Tracker

Every USFDA inspection, Form 483, OAI classification, warning letter, import alert and approval for listed Indian pharma companies — plant by plant, with a source link on every record. Free, updated automatically every day.

1416
USFDA inspections of Indian plants on record
41%
Closed clean (NAI)
51%
Minor issues (VAI)
9%
Serious issues (OAI)
111
Indian plants on Import Alert 66-40
Latest USFDA events All updates →
27 Oct 2026
US approval Zydus Lifesciences
USFDA approval: TRANEXAMIC ACID
ANDA221213 — TRANEXAMIC ACID
Source: openFDA Drugs@FDA ↗
27 Oct 2026
Import alert
Added to FDA import alert 66-40
COHESION BIOTEC PRIVATE LIMITED, 002 Survey No 1112, Opp Shreeji Plastic, Ghumasan, Gujarat INDIA
Source: FDA import alerts ↗
23 Oct 2026
USFDA approval: TERIPARATIDE
ANDA214412 — TERIPARATIDE
Source: openFDA Drugs@FDA ↗
20 Oct 2026
US approval Zydus Lifesciences
USFDA approval: BRIVARACETAM
ANDA221301 — BRIVARACETAM
Source: openFDA Drugs@FDA ↗
19 Oct 2026
US approval Zydus Lifesciences
USFDA approval: ESTRADIOL AND LEVONORGESTREL
ANDA220407 — ESTRADIOL, LEVONORGESTREL
Source: openFDA Drugs@FDA ↗
19 Oct 2026
US approval Ajanta Pharma
USFDA approval: TOFACITINIB CITRATE
ANDA219542 — TOFACITINIB CITRATE
Source: openFDA Drugs@FDA ↗
19 Oct 2026
US approval Zydus Lifesciences
USFDA approval: ROMIDEPSIN
ANDA220783 — ROMIDEPSIN
Source: openFDA Drugs@FDA ↗
16 Oct 2026
USFDA approval: LORATADINE AND PSEUDOEPHEDRINE SULFATE
ANDA220432 — LORATADINE, PSEUDOEPHEDRINE SULFATE
Source: openFDA Drugs@FDA ↗
16 Oct 2026
US approval Cipla
USFDA approval: CABOZANTINIB S-MALATE
ANDA217870 — CABOZANTINIB S-MALATE
Source: openFDA Drugs@FDA ↗
16 Oct 2026
US approval Aurobindo Pharma
USFDA approval: UPADACITINIB
ANDA218866 — UPADACITINIB
Source: openFDA Drugs@FDA ↗
15 Oct 2026
US approval Zydus Lifesciences
USFDA tentative approval:
ANDA218568 —
Source: openFDA Drugs@FDA ↗
13 Oct 2026
USFDA approval: MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE
ANDA208359 — DONEPEZIL HYDROCHLORIDE, MEMANTINE HYDROCHLORIDE
Source: openFDA Drugs@FDA ↗
Lowest compliance scores (5 years) Full scorecard →
Intas Pharmaceuticals (unlisted)
3 plant(s) · last: OAI — serious issues 16 Sep 2025
3
Cipla
6 plant(s) · last: US approval 16 Oct 2026
33
Sun Pharmaceutical Industries
10 plant(s) · last: NAI — clean 11 Sep 2026
37
Aurobindo Pharma
7 plant(s) · last: US approval 16 Oct 2026
38
Jubilant Pharmova
2 plant(s) · last: US approval 17 Aug 2026
40
Glenmark Pharmaceuticals
5 plant(s) · last: US approval 08 Sep 2026
47
Highest compliance scores (5 years)
Syngene International
3 plant(s)
90
Ajanta Pharma
2 plant(s)
87
JB Chemicals & Pharmaceuticals
3 plant(s)
87
Alembic Pharmaceuticals
8 plant(s)
80
Alkem Laboratories
4 plant(s)
80
Caplin Point Laboratories
1 plant(s)
80
Score: 100 = clean USFDA record over 5 years. It falls with OAI classifications, open warning letters, import alerts and Form 483s. How it's calculated. It describes past regulatory records only — it is not a rating of the stock.