DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
01 1Dr. Reddy's Laboratories
02 1Alembic Pharmaceuticals Limited
03 1Apotex Pharmachem
04 2Astellas Pharma
05 1Aurobindo Pharma Limited
06 1Azico Biophore India Pvt. Ltd
07 1Ercros
08 1Gedeon Richter
09 1Hetero Drugs
10 1MSN Laboratories
11 1NAKODA CHEMICALS LIMITED
12 1Orchev Pharma
13 2Quimica Sintetica
14 1RICHTER THEMIS MEDICARE I PVT LTD
15 1SMS Pharmaceuticals
16 1SREENIVASA PHARMA PRIVATE LTD
17 1Sms Lifesciences
18 1TONIRA PHARMA LTD
19 1UQUIFA
20 1Wockhardt
21 1Yung Shin Pharmaceutical Industrial
22 1Zydus Lifesciences
01 9FAMOTIDINE
02 1FAMOTIDINE DRUG SUBSTANCE
03 12FAMOTIDINE USP
04 1FAMOTIDINE “YUNG SHIN”
05 1FAMOTIDINE, USP
01 1Canada
02 1China
03 1Hungary
04 15India
05 2Japan
06 4Spain
01 17Active
02 7Inactive
01 11Complete
02 13Blank
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
GDUFA
DMF Review : Complete
Rev. Date : 2014-01-03
Pay. Date : 2013-11-25
DMF Number : 14309
Submission : 1999-07-22
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 25581
Submission : 2011-12-12
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 7356
Submission : 1988-02-29
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2021-03-24
Pay. Date : 2021-03-17
DMF Number : 35592
Submission : 2021-02-16
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13086
Submission : 1998-07-21
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 11537
Submission : 1995-06-05
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2022-03-07
Pay. Date : 2022-03-02
DMF Number : 13036
Submission : 1998-06-17
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2014-01-14
Pay. Date : 2013-08-30
DMF Number : 21442
Submission : 2008-03-20
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2021-02-07
Pay. Date : 2021-02-03
DMF Number : 19911
Submission : 2006-10-30
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2020-11-27
Pay. Date : 2020-11-23
DMF Number : 18524
Submission : 2005-07-19
Status : Active
Type : II
A Famotidine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Famotidine, including repackagers and relabelers. The FDA regulates Famotidine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Famotidine 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 Famotidine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Famotidine supplier is an individual or a company that provides Famotidine active pharmaceutical ingredient (API) or Famotidine finished formulations upon request. The Famotidine suppliers may include Famotidine API manufacturers, exporters, distributors and traders.
click here to find a list of Famotidine suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Famotidine DMF (Drug Master File) is a document detailing the whole manufacturing process of Famotidine active pharmaceutical ingredient (API) in detail. Different forms of Famotidine DMFs exist exist since differing nations have different regulations, such as Famotidine USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Famotidine DMF submitted to regulatory agencies in the US is known as a USDMF. Famotidine USDMF includes data on Famotidine's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Famotidine USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Famotidine suppliers with USDMF on PharmaCompass.
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