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Caplin Point Laboratories — USFDA Status
Inspections, Form 483 observations, OAI classifications, warning letters, import alerts and approvals for Caplin Point Laboratories (NSE: CAPLIPOINT, BSE: 524742), from US FDA records and exchange filings.
80
Compliance score (5 years) · how
1
USFDA-inspected plants on record
0
OAI classifications (5y)
0
Form 483s on record (5y)
0
Open warning letters
Latest USFDA record: USFDA inspection classified NAI — 09 Aug 2024 (Gummidipoondi plant). Source: FDA Data Dashboard.
USFDA events by year
2023
2024
2025
2026
NAIVAIForm 483OAIWarning letterImport alertUS approval
Plants
| Plant | FEI | Latest result | Last inspection | History (newest first) |
|---|---|---|---|---|
| Gummidipoondi Caplin Steriles Limited |
3005035920 | NAI | 09 Aug 2024 |
Full USFDA timeline
13 May 2026
US approval
USFDA approval: FOSCARNET SODIUM
ANDA220068 — FOSCARNET SODIUM
Source: openFDA Drugs@FDA ↗
04 May 2026
US approval
USFDA approval: CALCIUM GLUCONATE
ANDA218840 — CALCIUM GLUCONATE
Source: openFDA Drugs@FDA ↗
12 Mar 2026
US approval
USFDA approval: POTASSIUM PHOSPHATES
ANDA220373 — POTASSIUM PHOSPHATE, DIBASIC, POTASSIUM PHOSPHATE, MONOBASIC
Source: openFDA Drugs@FDA ↗
27 Feb 2026
US approval
USFDA approval: DESMOPRESSIN ACETATE
ANDA219981 — DESMOPRESSIN ACETATE
Source: openFDA Drugs@FDA ↗
24 Feb 2026
23 Feb 2026
US approval
USFDA approval: SODIUM PHOSPHATES
ANDA220683 — SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE, SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE
Source: openFDA Drugs@FDA ↗
26 Jan 2026
US approval
USFDA approval: METHYLPREDNISOLONE ACETATE
ANDA220556 — METHYLPREDNISOLONE ACETATE
Source: openFDA Drugs@FDA ↗
08 Dec 2025
05 Dec 2025
22 Oct 2025
US approval
USFDA approval: NICARDIPINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE
ANDA220243 — NICARDIPINE HYDROCHLORIDE
Source: openFDA Drugs@FDA ↗
02 Sep 2025
US approval
USFDA approval: MILRINONE LACTATE IN DEXTROSE 5%
ANDA219170 — MILRINONE LACTATE
Source: openFDA Drugs@FDA ↗
07 Aug 2025
US approval
USFDA approval: KETAMINE HYDROCHLORIDE
ANDA217858 — KETAMINE HYDROCHLORIDE
Source: openFDA Drugs@FDA ↗
13 May 2025
US approval
USFDA approval: HALOPERIDOL DECANOATE
ANDA219168 — HALOPERIDOL DECANOATE
Source: openFDA Drugs@FDA ↗
17 Apr 2025
25 Feb 2025
US approval
USFDA approval: BRIMONIDINE TARTRATE AND TIMOLOL MALEATE
ANDA219093 — BRIMONIDINE TARTRATE, TIMOLOL MALEATE
Source: openFDA Drugs@FDA ↗
04 Feb 2025
US approval
USFDA approval: PROCAINAMIDE HYDROCHLORIDE
ANDA218674 — PROCAINAMIDE HYDROCHLORIDE
Source: openFDA Drugs@FDA ↗
16 Jan 2025
US approval
USFDA approval: LEVETIRACETAM IN SODIUM CHLORIDE
ANDA219562 — LEVETIRACETAM
Source: openFDA Drugs@FDA ↗
13 Dec 2024
09 Aug 2024
NAI — clean
USFDA inspection classified NAI
Gummidipoondi · FEI 3005035920 · Caplin Steriles Limited, Gummidipoondi — Bioresearch Monitoring (Drugs)
Source: FDA Data Dashboard ↗
07 Aug 2024
US approval
USFDA approval: TIMOLOL MALEATE
ANDA218460 — TIMOLOL MALEATE
Source: openFDA Drugs@FDA ↗
18 Jul 2024
US approval
USFDA approval: EPHEDRINE SULFATE
ANDA219050 — EPHEDRINE SULFATE
Source: openFDA Drugs@FDA ↗
23 May 2024
US approval
USFDA approval: PHENYLEPHRINE HYDROCHLORIDE
ANDA215183 — PHENYLEPHRINE HYDROCHLORIDE
Source: openFDA Drugs@FDA ↗
12 Apr 2024
26 Mar 2024
US approval
USFDA approval: KETOROLAC TROMETHAMINE
ANDA218204 — KETOROLAC TROMETHAMINE
Source: openFDA Drugs@FDA ↗
05 Jan 2024
31 May 2023
VAI — minor issues
USFDA inspection classified VAI
Gummidipoondi · FEI 3005035920 · Caplin Steriles Limited, Gummidipoondi — Drug Quality Assurance (Drugs)
Source: FDA Data Dashboard ↗
📎 Cite this data: Source: PharmaRoz analysis of FDA inspection data and exchange filings, updated 12 Nov 2026 — https://pharmaroz.com/company/caplin