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USFDA Status of Indian Pharma Companies
Compliance scorecard built from US FDA inspection data, warning letters and import alerts. Click a company for its full plant-by-plant record and sources.
| Company | Score | USFDA plants | OAI (5y) | VAI (5y) | Form 483s (5y) | Open warning letters | Import alerts | Latest event |
|---|---|---|---|---|---|---|---|---|
| Intas Pharmaceuticals (unlisted) | 3 | 3 | 2 | — | 1 | 1 | 2 | OAI — serious issues 16 Sep 2025 |
| Cipla NSE: CIPLA |
33 | 6 | 2 | 5 | 1 | 1 | — | US approval 16 Oct 2026 |
| Sun Pharmaceutical Industries NSE: SUNPHARMA |
37 | 10 | 3 | 4 | 2 | — | 4 | NAI — clean 11 Sep 2026 |
| Aurobindo Pharma NSE: AUROPHARMA |
38 | 7 | 5 | 6 | 3 | — | — | US approval 16 Oct 2026 |
| Jubilant Pharmova NSE: JUBLPHARMA |
40 | 2 | 1 | 2 | 1 | — | — | US approval 17 Aug 2026 |
| Glenmark Pharmaceuticals NSE: GLENMARK |
47 | 5 | 3 | 1 | 1 | — | 1 | US approval 08 Sep 2026 |
| Aarti Drugs NSE: AARTIDRUGS |
50 | 1 | — | 1 | — | — | 1 | VAI — minor issues 20 Sep 2024 |
| Hikal NSE: HIKAL |
50 | 2 | 1 | — | — | — | — | OAI — serious issues 07 Feb 2025 |
| Indoco Remedies NSE: INDOCO |
55 | 4 | 1 | 1 | 1 | 1 | — | US approval 31 Oct 2025 |
| Ipca Laboratories NSE: IPCALAB |
60 | 4 | — | 5 | — | — | — | VAI — minor issues 05 Dec 2025 |
| Mankind Pharma NSE: MANKIND |
60 | 3 | — | 3 | — | — | — | US approval 31 Jul 2026 |
| Strides Pharma Science NSE: STAR |
60 | 3 | — | 4 | 2 | — | — | US approval 13 Oct 2026 |
| Biocon NSE: BIOCON |
62 | 8 | 1 | 7 | — | — | — | US approval 19 Aug 2026 |
| Laurus Labs NSE: LAURUSLABS |
63 | 6 | 1 | 3 | — | — | — | US approval 09 Jul 2026 |
| Lupin NSE: LUPIN |
64 | 14 | 3 | 6 | 2 | — | — | US approval 30 Sep 2026 |
| Zydus Lifesciences NSE: ZYDUSLIFE |
65 | 12 | 2 | 9 | 2 | — | — | US approval 27 Oct 2026 |
| Shilpa Medicare NSE: SHILPAMED |
66 | 5 | — | 3 | 1 | — | 1 | NAI — clean 14 Mar 2025 |
| Natco Pharma NSE: NATCOPHARM |
68 | 5 | — | 4 | — | — | — | US approval 13 Jul 2026 |
| Unichem Laboratories NSE: UNICHEMLAB |
68 | 5 | — | 4 | — | — | — | US approval 29 Sep 2026 |
| Emcure Pharmaceuticals NSE: EMCURE |
70 | 5 | — | 3 | 1 | — | 1 | VAI — minor issues 15 May 2026 |
| Neuland Laboratories NSE: NEULANDLAB |
70 | 3 | — | 3 | — | — | — | VAI — minor issues 14 Aug 2026 |
| Wockhardt NSE: WOCKPHARMA |
70 | 0 | — | — | — | — | 3 | US approval 29 May 2026 |
| Dr. Reddy's Laboratories NSE: DRREDDY |
71 | 12 | — | 10 | 1 | — | — | US approval 23 Oct 2026 |
| Concord Biotech NSE: CONCORDBIO |
73 | 3 | — | 2 | — | — | — | US approval 09 Jun 2026 |
| Marksans Pharma NSE: MARKSANS |
73 | 2 | — | 2 | 1 | — | — | NAI — clean 07 Nov 2025 |
| Gland Pharma NSE: GLAND |
75 | 4 | — | 5 | 2 | — | — | US approval 02 Mar 2026 |
| Cohance Lifesciences | 77 | 7 | — | 4 | — | — | — | VAI — minor issues 31 Oct 2025 |
| Torrent Pharmaceuticals NSE: TORNTPHARM |
78 | 5 | 1 | 2 | — | — | — | US approval 20 Apr 2026 |
| Alembic Pharmaceuticals NSE: APLLTD |
80 | 8 | — | 5 | 2 | — | — | US approval 10 Jun 2026 |
| Alkem Laboratories NSE: ALKEM |
80 | 4 | — | 2 | — | — | — | US approval 24 Mar 2026 |
| Caplin Point Laboratories NSE: CAPLIPOINT |
80 | 1 | — | 1 | — | — | — | US approval 13 May 2026 |
| Divi's Laboratories NSE: DIVISLAB |
80 | 2 | — | 1 | — | — | — | NAI — clean 14 Nov 2025 |
| Granules India NSE: GRANULES |
80 | 4 | — | 1 | — | 1 | — | US approval 07 Jan 2026 |
| Piramal Pharma NSE: PPLPHARMA |
80 | 3 | — | 2 | — | — | — | VAI — minor issues 13 Feb 2026 |
| Solara Active Pharma Sciences NSE: SOLARA |
80 | 6 | — | 3 | — | — | — | VAI — minor issues 06 Feb 2026 |
| Ajanta Pharma NSE: AJANTPHARM |
87 | 2 | — | 1 | — | — | — | US approval 19 Oct 2026 |
| JB Chemicals & Pharmaceuticals NSE: JBCHEPHARM |
87 | 3 | — | 1 | — | — | — | NAI — clean 13 Mar 2025 |
| Syngene International NSE: SYNGENE |
90 | 3 | — | 1 | — | — | — | VAI — minor issues 20 Feb 2025 |
Counts cover the last 5 years (import alerts: currently listed). Score method: Methodology. Past regulatory records only — not a stock rating or advice.
📎 Cite this data: Source: PharmaRoz USFDA compliance scorecard (FDA inspection data), 12 Nov 2026 — https://pharmaroz.com/usfda-tracker