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USFDA Updates for Indian Pharma Companies

Company filings about USFDA inspections, observations and approvals (checked before publishing), plus the latest records published by the US FDA.

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Latest FDA records
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 ↗
06 Oct 2026
US approval Aurobindo Pharma
USFDA approval: SOLRIAMFETOL, SOLRIAMFETOL HYDROCHLORIDE
ANDA218725 — SOLRIAMFETOL, SOLRIAMFETOL HYDROCHLORIDE
Source: openFDA Drugs@FDA ↗
02 Oct 2026
US approval Aurobindo Pharma
USFDA approval: PERAMPANEL
ANDA220492 — PERAMPANEL
Source: openFDA Drugs@FDA ↗
02 Oct 2026
US approval Aurobindo Pharma
USFDA tentative approval:
ANDA219349 —
Source: openFDA Drugs@FDA ↗
30 Sep 2026
US approval Lupin
USFDA approval: PHYTONADIONE
ANDA219175 — PHYTONADIONE
Source: openFDA Drugs@FDA ↗
29 Sep 2026
USFDA tentative approval: SOLRIAMFETOL
ANDA218761 — SOLRIAMFETOL
Source: openFDA Drugs@FDA ↗
29 Sep 2026
US approval Zydus Lifesciences
USFDA approval: MUPIROCIN CALCIUM
ANDA218361 — MUPIROCIN CALCIUM
Source: openFDA Drugs@FDA ↗
25 Sep 2026
US approval Lupin
USFDA tentative approval: APIXABAN
NDA220446 — APIXABAN (Type 3 - New Dosage Form)
Source: openFDA Drugs@FDA ↗
25 Sep 2026
US approval Aurobindo Pharma
USFDA approval: METRONIDAZOLE
ANDA218485 — METRONIDAZOLE
Source: openFDA Drugs@FDA ↗
23 Sep 2026
US approval Zydus Lifesciences
USFDA approval: MEXILETINE HYDROCHLORIDE
ANDA214598 — MEXILETINE HYDROCHLORIDE
Source: openFDA Drugs@FDA ↗
18 Sep 2026
NAI — clean Shodhana Laboratories Private Limited
USFDA inspection classified NAI
Parawada, Visakhapatnam · FEI 3029445647 · Shodhana Laboratories Private Limited, Parawada, Visakhapatnam — Drug Quality Assurance (Drugs)
Source: FDA Data Dashboard ↗
18 Sep 2026
NAI — clean Mahi Drugs Private Limited
USFDA inspection classified NAI
Visakhapatnam · FEI 3019853340 · Mahi Drugs Private Limited, Visakhapatnam — Drug Quality Assurance (Drugs)
Source: FDA Data Dashboard ↗
17 Sep 2026
US approval Cipla
USFDA approval: CALCIUM GLUCONATE IN SODIUM CHLORIDE
ANDA217891 — CALCIUM GLUCONATE
Source: openFDA Drugs@FDA ↗
17 Sep 2026
US approval Aurobindo Pharma
USFDA approval: CYCLOSPORINE
ANDA219652 — CYCLOSPORINE
Source: openFDA Drugs@FDA ↗
15 Sep 2026
US approval Zydus Lifesciences
USFDA approval: TRETINOIN
ANDA218560 — TRETINOIN
Source: openFDA Drugs@FDA ↗
15 Sep 2026
USFDA approval: MILNACIPRAN HYDROCHLORIDE
ANDA207399 — MILNACIPRAN HYDROCHLORIDE
Source: openFDA Drugs@FDA ↗
14 Sep 2026
US approval Zydus Lifesciences
USFDA approval: EPINEPHRINE
ANDA219832 — EPINEPHRINE
Source: openFDA Drugs@FDA ↗
14 Sep 2026
US approval Zydus Lifesciences
USFDA approval: LETROZOLE
ANDA220438 — LETROZOLE
Source: openFDA Drugs@FDA ↗
14 Sep 2026
US approval Ajanta Pharma
USFDA approval: HALOPERIDOL
ANDA218210 — HALOPERIDOL
Source: openFDA Drugs@FDA ↗
14 Sep 2026
US approval Aurobindo Pharma
USFDA approval: BECLOMETHASONE DIPROPIONATE
ANDA214418 — BECLOMETHASONE DIPROPIONATE
Source: openFDA Drugs@FDA ↗
11 Sep 2026
VAI — minor issues Dr. Sunil Soitawala
USFDA inspection classified VAI
Mehsana · FEI 3044620160 · Dr. Sunil Soitawala, Mehsana — Bioresearch Monitoring (Drugs)
Source: FDA Data Dashboard ↗
11 Sep 2026
USFDA inspection classified NAI
Ahmednagar · FEI 3003227153 · Sun Pharmaceutical Industries Limited, Ahmednagar — Drug Quality Assurance (Drugs)
Source: FDA Data Dashboard ↗
11 Sep 2026
NAI — clean Apitoria Pharma Private Limited
USFDA inspection classified NAI
Srikakulam · FEI 3004611182 · Apitoria Pharma Private Limited, Srikakulam — Drug Quality Assurance (Drugs)
Source: FDA Data Dashboard ↗
10 Sep 2026
US approval Aurobindo Pharma
USFDA approval: ISOTRETINOIN
ANDA220336 — ISOTRETINOIN
Source: openFDA Drugs@FDA ↗
10 Sep 2026
NAI — clean Pratik Doshi, M.D.
USFDA inspection classified NAI
Vadodara · FEI 3033605025 · Pratik Doshi, M.D., Vadodara — Bioresearch Monitoring (Drugs)
Source: FDA Data Dashboard ↗
10 Sep 2026
VAI — minor issues Council of Scientific & Industrial Research-Indian Institute of Chemical Technology
USFDA inspection classified VAI
Hyderabad · FEI 3008282851 · Council of Scientific & Industrial Research-Indian Institute of Chemical Technology, Hyderabad — Drug Quality Assurance (Drugs)
Source: FDA Data Dashboard ↗
08 Sep 2026
USFDA tentative approval:
ANDA220307 —
Source: openFDA Drugs@FDA ↗
04 Sep 2026
Form 483 Aparna Marine Exports
Form 483: 1 observation
Bapatla · FEI 3023806159 · Sanitation monitoring
Source: FDA Data Dashboard (citations) ↗
04 Sep 2026
VAI — minor issues Aparna Marine Exports
USFDA inspection classified VAI
Bapatla · FEI 3023806159 · Aparna Marine Exports, Bapatla — Foodborne Biological Hazards (Food/Cosmetics)
Source: FDA Data Dashboard ↗