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Drug company (FDA labeler)

Marksans Pharma Limited

Name in FDA records: MARKSANS PHARMA LIMITED

NDC labeler code: 25000

What is a labeler?

The company whose name is on the package and in the FDA’s National Drug Code (NDC) Directory. It may make the medicine itself or sell medicine made by another company. The first part of every NDC code identifies the labeler.

Official FDA data only

Products, approvals and recalls come from the FDA (NDC Directory, Drugs@FDA, enforcement reports). Recalls are linked to this company by the NDC labeler code on the recalled product.

Questions about your medicine: ask your doctor or pharmacist. In an emergency, call 911.

At a glance

10Prescription medicines
34Products (NDC)
11FDA applications
3Recalls

Prescription medicines

FDA applications for these products

  • ANDA: Abbreviated New Drug Application: how a generic version is approved.
ApprovedApplicationMedicineSponsor
March 30, 2026ANDA220298 Benzonatate
BENZONATATE		Pharmazone
July 18, 2022ANDA216197 Pregabalin
PREGABALIN		Pharmazone
April 7, 2017ANDA204376 Dutasteride
DUTASTERIDE		Pharmazone
October 7, 2016ANDA204948 Paricalcitol
PARICALCITOL		Pharmazone
April 29, 2016ANDA090295 Metformin hydrochloride
METFORMIN HYDROCHLORIDE		Pharmazone
December 11, 2013ANDA090723 Duloxetine
DULOXETINE HYDROCHLORIDE		Pharmazone
March 12, 2012ANDA090888 Metformin hydrochloride
METFORMIN HYDROCHLORIDE		Pharmazone
July 21, 2011ANDA090007 Gabapentin
GABAPENTIN		Pharmazone
February 14, 2011ANDA091416 Naproxen
NAPROXEN		Pharmazone
December 21, 2010ANDA090796 Ibuprofen
IBUPROFEN		Pharmazone
January 29, 2002ANDA075465 Fluoxetine
FLUOXETINE HYDROCHLORIDE		Pharmazone

The sponsor is the company that holds the FDA application; it can differ from the labeler.

Recall timeline

2018

  1. January 9, 2018 · Class II · Terminated · D-0239-2018 · Ibuprofen

    CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complaints of odor related to CGMP deficiencies.

    Ibuprofen Tablets, USP 600 mg, 6 x 2500 Tablets bulk packed in double polybag shipper packs for further packaging, Rx only, Manufactured by: Marksans Pharma Ltd., Plot No. L-82, L-83, Verna Indl. Estate, Verna, Goa - 403

  2. January 9, 2018 · Class II · Terminated · D-0240-2018 · Ibuprofen

    CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complaints of odor related to CGMP deficiencies.

    Ibuprofen Tablets, USP 800 mg, 6 x 1900 Tablets bulk packed in double polybag shipper packs for further packaging, Rx only, Manufactured by: Marksans Pharma Ltd., Plot No. L-82, L-83, Verna Indl. Estate, Verna, Goa - 403

  3. January 9, 2018 · Class II · Terminated · D-0238-2018 · Ibuprofen

    CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complaints of odor related to CGMP deficiencies.

    Ibuprofen Tablets, USP 400 mg, 6 x 3500 Tablets bulk packed in double polybag shipper packs for further packaging, Rx only, Manufactured by: Marksans Pharma Ltd., Plot No. L-82, L-83, Verna Indl. Estate, Verna, Goa - 403

What do the recall classes mean?

Class I: The most serious type: there is a reasonable chance that using the product will cause serious health problems or death.
Class II: Using the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
Class III: Using the product is not likely to cause health problems (for example a labeling or packaging issue).

Sources

  1. NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
  2. Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
  3. Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026

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