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GABAPENTIN

ANDA

GABAPENTIN | A216252 | EPIC PHARMA LLC

2 strengths0 unique patents0 unique exclusivities

Reference Listed Drug: GRALISE(TE code: AB2)

API Supply Chain24 active DMFs10 inactive

21 active API suppliers hold Drug Master Files for this ingredient.

TAPI NL BVGABAPENTIN

DMF 127361997

FIS FABBRICA ITALIANA SINTETICI SPAGABAPENTIN

DMF 140241999

HIKAL LTDGABAPENTIN USP

DMF 160602002

TARO PHARMACEUTICAL INDUSTRIES LTDGABAPENTIN USP

DMF 161512002

SUVEN PHARMACEUTICALS LTDGABAPENTIN USP

DMF 170632003

SUN PHARMACEUTICAL INDUSTRIES LTDGABAPENTIN USP

DMF 172402004

SOLARA ACTIVE PHARMA SCIENCES LTDGABAPENTIN USP

DMF 175432004

OLON SPAGABAPENTIN

DMF 181712005

MATRIX PHARMACORP PRIVATE LTDGABAPENTIN USP

DMF 182252005

DIVIS LABORATORIES LTDGABAPENTIN USP

DMF 190002005

APITORIA PHARMA PRIVATE LTDGABAPENTIN USP (NON-STERILE DRUG SUBSTANCE)

DMF 201222006

ZHEJIANG CHIRAL MEDICINE CHEMICALS CO LTDGABAPENTIN

DMF 208262007

ANJAN DRUG PRIVATE LTDGABAPENTIN USP

DMF 227652009

JIANGXI SYNERGY PHARMACEUTICAL CO LTDGABAPENTIN

DMF 258252012

HETERO DRUGS LTDGABAPENTIN

DMF 261312012

ZHEJIANG EXCEL PHARMACEUTICAL CO LTDGABAPENTIN USP

DMF 265142012

TAPI NL BVGABAPENTIN BUTANOL PROCESS

DMF 271242013

SARACA LABORATORIES LTDGABAPENTIN USP

DMF 308092017

HETERO DRUGS LTDGABAPENTIN (PROCESS-II)

DMF 318192017

JIANGXI SYNERGY PHARMACEUTICAL CO LTDGABAPENTIN (E)

DMF 343152020

ZHEJIANG HUAHAI PHARMACEUTICAL CO LTDGABAPENTIN USP

DMF 362412021

EMNAR PHARMA PRIVATE LTDGABAPENTIN USP

DMF 370282022

ZHEJIANG YONGTAI CHIRAL MEDICINE TECHNOLOGY CO LTDGABAPENTIN

DMF 372432022

ZHEJIANG BAMBOO PHARMACEUTICALS CO LTDGABAPENTIN

DMF 377612023

ERREGIERRE SPAInactiveGABAPENTIN

DMF 155132001

SUN PHARMACEUTICAL INDUSTRIES LTDInactiveGABAPENTIN USP (NON-STERILE BULK)

DMF 162872002

PROCOS SPAInactiveGABAPENTIN

DMF 163422002

ERREGIERRE SPAInactiveGABAPENTIN

DMF 173512004

SANDOZ INDUSTRIAL PRODUCTS SAInactiveGABAPENTIN (NON-STERILE BULK)

DMF 184892005

JIANGSU NHWA PHARMACEUTICAL CO LTDInactiveGABAPENTIN

DMF 206452007

JIANGXI SYNERGY PHARMACEUTICAL CO LTDInactiveGABAPENTIN

DMF 214012008

GRANULES INDIA LTDInactiveGABAPENTIN USP

DMF 335362019

IOL CHEMICALS AND PHARMACEUTICALS LTDInactiveGABAPENTIN USP

DMF 365362022

ZHEJIANG APELOA JIAYUAN PHARMACEUTICAL CO LTDInactiveGABAPENTIN

DMF 413112025

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Products (2)

Sort:

#001 — 300MG

AB2

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Feb 26, 2024

No patent or exclusivity listings for this strength.

#002 — 600MG

AB2

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Feb 26, 2024

Change History (4)

Recent changes detected for this application.

MODIFIEDApplicant7/1/2026

Epic Pharma LLC replaced Humanwell as the applicant for Gabapentin NDA 216252.

Old: HUMANWELL

New: EPIC PHARMA LLC

MODIFIEDApplicant Full Name7/1/2026

Epic Pharma LLC replaced Humanwell Pharmaceutical US Inc as the listed applicant for Gabapentin NDA 216252, indicating a change in the responsible manufacturer or distributor for this generic formulation.

Old: HUMANWELL PHARMACEUTICAL US INC

New: EPIC PHARMA LLC

MODIFIEDApplicant7/1/2026

EPIC PHARMA LLC became the applicant for gabapentin NDA 216252, replacing HUMANWELL as the listed manufacturer.

Old: HUMANWELL

New: EPIC PHARMA LLC

MODIFIEDApplicant Full Name7/1/2026

EPIC PHARMA LLC replaced HUMANWELL PHARMACEUTICAL US INC as the applicant for gabapentin NDA 216252.

Old: HUMANWELL PHARMACEUTICAL US INC

New: EPIC PHARMA LLC