01 1ACIC Europe API & Pharmaceuticals
02 1Dipharma
03 1F. Hoffmann-La Roche
04 2Industriale Chimica
05 1Mankind Pharma
06 1R L Fine Chem
07 1Siegfried AG
08 1Sifavitor srl
09 1Sun Pharmaceutical Industries Limited
10 1Teva Pharmaceutical Industries
11 1Vasudha Pharma Chem
12 2Blank
01 3AMITRIPTYLINE HCL
02 1AMITRIPTYLINE HCL B.P. 88/USP
03 1AMITRIPTYLINE HCL USP DRUG SUBSTANCE
04 3AMITRIPTYLINE HYDROCHLORIDE
05 4AMITRIPTYLINE HYDROCHLORIDE USP
06 1AMITRYPTILINE HCL
07 1PROCEDURES FOR
01 1Cyprus
02 4India
03 1Israel
04 4Italy
05 2Switzerland
06 2Blank
01 7Active
02 7Inactive
01 4Complete
02 10Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 2908
Submission : 1977-03-18
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 2413
Submission : 1975-03-10
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 2535
Submission : 1975-10-06
Status : Inactive
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2019-09-16
Pay. Date : 2019-07-15
DMF Number : 33565
Submission : 2019-07-24
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2017-03-22
Pay. Date : 2016-09-26
DMF Number : 18111
Submission : 2005-02-10
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 3008
Submission : 1977-07-17
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 2598
Submission : 1976-01-28
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 19589
Submission : 2006-07-12
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2017-03-17
Pay. Date : 2017-03-02
DMF Number : 2719
Submission : 1976-08-09
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2015-09-28
Pay. Date : 2015-09-21
DMF Number : 19635
Submission : 2006-07-28
Status : Active
Type : II
A Amitriptyline Hydrochloride manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Amitriptyline Hydrochloride, including repackagers and relabelers. The FDA regulates Amitriptyline Hydrochloride manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Amitriptyline Hydrochloride 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 Amitriptyline Hydrochloride manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Amitriptyline Hydrochloride supplier is an individual or a company that provides Amitriptyline Hydrochloride active pharmaceutical ingredient (API) or Amitriptyline Hydrochloride finished formulations upon request. The Amitriptyline Hydrochloride suppliers may include Amitriptyline Hydrochloride API manufacturers, exporters, distributors and traders.
click here to find a list of Amitriptyline Hydrochloride suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Amitriptyline Hydrochloride DMF (Drug Master File) is a document detailing the whole manufacturing process of Amitriptyline Hydrochloride active pharmaceutical ingredient (API) in detail. Different forms of Amitriptyline Hydrochloride DMFs exist exist since differing nations have different regulations, such as Amitriptyline Hydrochloride USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Amitriptyline Hydrochloride DMF submitted to regulatory agencies in the US is known as a USDMF. Amitriptyline Hydrochloride USDMF includes data on Amitriptyline Hydrochloride's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Amitriptyline Hydrochloride USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Amitriptyline Hydrochloride suppliers with USDMF on PharmaCompass.
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