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 ORIG — UNKNOWN (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
US approval
Dr. Reddy's Laboratories
USFDA approval: TERIPARATIDE
ANDA214412 ORIG — UNKNOWN (TERIPARATIDE)
Source: openFDA Drugs@FDA ↗
20 Oct 2026
US approval
Zydus Lifesciences
USFDA approval: BRIVARACETAM
ANDA221301 ORIG — UNKNOWN (BRIVARACETAM)
Source: openFDA Drugs@FDA ↗
19 Oct 2026
US approval
Zydus Lifesciences
USFDA approval: ESTRADIOL AND LEVONORGESTREL
ANDA220407 ORIG — UNKNOWN (ESTRADIOL, LEVONORGESTREL)
Source: openFDA Drugs@FDA ↗
19 Oct 2026
US approval
Ajanta Pharma
USFDA approval: TOFACITINIB CITRATE
ANDA219542 ORIG — UNKNOWN (TOFACITINIB CITRATE)
Source: openFDA Drugs@FDA ↗
19 Oct 2026
US approval
Zydus Lifesciences
USFDA approval: ROMIDEPSIN
ANDA220783 ORIG — UNKNOWN (ROMIDEPSIN)
Source: openFDA Drugs@FDA ↗
16 Oct 2026
US approval
Dr. Reddy's Laboratories
USFDA approval: LORATADINE AND PSEUDOEPHEDRINE SULFATE
ANDA220432 ORIG — UNKNOWN (LORATADINE, PSEUDOEPHEDRINE SULFATE)
Source: openFDA Drugs@FDA ↗
16 Oct 2026
US approval
Cipla
USFDA approval: CABOZANTINIB S-MALATE
ANDA217870 ORIG — UNKNOWN (CABOZANTINIB S-MALATE)
Source: openFDA Drugs@FDA ↗
16 Oct 2026
US approval
Aurobindo Pharma
USFDA approval: UPADACITINIB
ANDA218866 ORIG — UNKNOWN (UPADACITINIB)
Source: openFDA Drugs@FDA ↗
15 Oct 2026
US approval
Zydus Lifesciences
USFDA tentative approval:
ANDA218568 ORIG — UNKNOWN ()
Source: openFDA Drugs@FDA ↗
13 Oct 2026
US approval
Strides Pharma Science
USFDA approval: MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE
ANDA208359 ORIG — UNKNOWN (DONEPEZIL HYDROCHLORIDE, MEMANTINE HYDROCHLORIDE)
Source: openFDA Drugs@FDA ↗
Lowest compliance scores (5 years) Full scorecard →
| Aurobindo Pharma 7 plant(s) · last: US approval 16 Oct 2026 | 0 |
| Cipla 6 plant(s) · last: US approval 16 Oct 2026 | 0 |
| Glenmark Pharmaceuticals 5 plant(s) · last: US approval 08 Sep 2026 | 0 |
| Intas Pharmaceuticals (unlisted) 3 plant(s) · last: OAI — serious issues 16 Sep 2025 | 0 |
| Lupin 14 plant(s) · last: US approval 30 Sep 2026 | 0 |
| Sun Pharmaceutical Industries 10 plant(s) · last: NAI — clean 11 Sep 2026 | 0 |
Highest compliance scores (5 years)
| Ajanta Pharma 2 plant(s) | 96 |
| Caplin Point Laboratories 1 plant(s) | 96 |
| Divi's Laboratories 2 plant(s) | 96 |
| JB Chemicals & Pharmaceuticals 3 plant(s) | 96 |
| Syngene International 3 plant(s) | 96 |
| Alkem Laboratories 4 plant(s) | 92 |
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.