IOL Chemicals is an innovation-driven bulk drug, Intermediate and Specialty Chemicals company.
01 1IOL Chemicals and Pharmaceuticals
02 2TAPI Technology & API Services
03 1Anjan Drug Private Limited
04 1Aurobindo Pharma Limited
05 1Divis Laboratories
06 1Emnar Pharma
07 2Erregierre SpA
08 1F.I.S. Fabbrica Italiana Sintetici
09 2Hetero Drugs
10 2Hikal
11 1Jiangsu Hengrui Medicine
12 1Jiangsu Nhwa Pharmaceutical
13 3Jiangxi Synergy Pharmaceutical
14 1Laboratorio Chimico Internazionale Spa
15 1Procos
16 1RANBAXY LABORATORIES LIMITED
17 1Sandoz B2B
18 1Saraca Laboratories Limited
19 1Solara Active Pharma Sciences
20 1Sun Pharmaceutical Industries Limited
21 1Suven Life Sciences Limited
22 1Taro Pharmaceutical Industries
23 1Viatris
24 1Zhejiang Bamboo Pharmaceuticals
25 1Zhejiang Excel Pharmaceutical
26 1Zhejiang Huahai Pharmaceutical
27 1Zhejiang Yongtai Technology
28 1Zhejiang chiral Medicine Chemicals Co
01 13GABAPENTIN
02 1GABAPENTIN USP
03 1GABAPENTIN (E)
04 1GABAPENTIN (NON-STERILE BULK)
05 1GABAPENTIN (PROCESS-II)
06 1GABAPENTIN BUTANOL PROCESS
07 12GABAPENTIN USP
08 1GABAPENTIN USP (NON-STERILE BULK)
09 1GABAPENTIN USP (NON-STERILE DRUG SUBSTANCE)
10 1GABAPENTIN, USP, NON-STERILE, BULK DRUG SUBSTANCE
11 1GABEPENTIN (A01804)
01 10China
02 14India
03 2Israel
04 5Italy
05 1Switzerland
06 2U.S.A
01 26Active
02 8Inactive
01 15Complete
02 19Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 36536
Submission : 2022-04-29
Status : Active
Type : II
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
GDUFA
DMF Review : Complete
Rev. Date : 2012-11-29
Pay. Date : 2012-11-08
DMF Number : 12736
Submission : 1997-11-12
Status : Active
Type : II
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
GDUFA
DMF Review : Complete
Rev. Date : 2013-09-16
Pay. Date : 2013-05-29
DMF Number : 27124
Submission : 2013-07-03
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 14024
Submission : 1999-03-19
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-01-18
Pay. Date : 2012-12-14
DMF Number : 16060
Submission : 2002-07-24
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 18171
Submission : 2005-03-03
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2012-10-26
Pay. Date : 2012-12-03
DMF Number : 17543
Submission : 2004-07-19
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 17240
Submission : 2004-03-18
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2018-09-05
Pay. Date : 2018-07-17
DMF Number : 17063
Submission : 2003-12-29
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 16151
Submission : 2002-09-25
Status : Active
Type : II
A Gabapentin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Gabapentin, including repackagers and relabelers. The FDA regulates Gabapentin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Gabapentin API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
click here to find a list of Gabapentin manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Gabapentin supplier is an individual or a company that provides Gabapentin active pharmaceutical ingredient (API) or Gabapentin finished formulations upon request. The Gabapentin suppliers may include Gabapentin API manufacturers, exporters, distributors and traders.
click here to find a list of Gabapentin suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Gabapentin DMF (Drug Master File) is a document detailing the whole manufacturing process of Gabapentin active pharmaceutical ingredient (API) in detail. Different forms of Gabapentin DMFs exist exist since differing nations have different regulations, such as Gabapentin USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Gabapentin DMF submitted to regulatory agencies in the US is known as a USDMF. Gabapentin USDMF includes data on Gabapentin's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Gabapentin USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Gabapentin suppliers with USDMF on PharmaCompass.
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