DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
01 1Dr. Reddy's Laboratories
02 1ALP Pharm
03 1Actavis Inc
04 1Amoli Organics
05 1Apotex Pharmachem
06 1Centaur Pharmaceuticals
07 1Charioteer
08 1Enaltec Labs Private Limited
09 1Hetero Drugs
10 1Jubilant Generics
11 1Lee Pharma
12 1Lupin Ltd
13 1Macleods Pharmaceuticals Limited
14 1Maithri Drugs
15 1Piramal Pharma Solutions
16 1Shilpa Medicare
17 1Unichem Laboratories Limited
18 1Viatris
19 2Viwit Pharmaceuticals Limited
01 17VARENICLINE TARTRATE
02 1VARENICLINE TARTRATE (DRUG SUBSTANCE, NON-STERILE)
03 1VARENICLINE TARTRATE MALTODEXTRIN PREMIX (1:10) [DRUG SUBSTANCE (NON-STERILE)]
04 1Varenicline Tartrate
01 1Canada
02 4China
03 12India
04 1Ireland
05 2U.S.A
01 18Active
02 2Inactive
01 10Complete
02 10Blank
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 38693
Submission : 2023-08-30
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 23791
Submission : 2010-05-06
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 23774
Submission : 2010-05-05
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2018-08-29
Pay. Date : 2018-07-31
DMF Number : 32835
Submission : 2018-06-19
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 32682
Submission : 2018-03-30
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2019-11-12
Pay. Date : 2019-07-24
DMF Number : 33016
Submission : 2018-11-29
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2017-05-15
Pay. Date : 2017-04-27
DMF Number : 31513
Submission : 2017-04-13
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2019-11-26
Pay. Date : 2019-10-23
DMF Number : 34096
Submission : 2019-09-27
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 23441
Submission : 2010-01-12
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2018-10-31
Pay. Date : 2018-09-11
DMF Number : 32638
Submission : 2018-02-22
Status : Active
Type : II
A Chantix manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Chantix, including repackagers and relabelers. The FDA regulates Chantix manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Chantix 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 Chantix manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Chantix supplier is an individual or a company that provides Chantix active pharmaceutical ingredient (API) or Chantix finished formulations upon request. The Chantix suppliers may include Chantix API manufacturers, exporters, distributors and traders.
click here to find a list of Chantix suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Chantix DMF (Drug Master File) is a document detailing the whole manufacturing process of Chantix active pharmaceutical ingredient (API) in detail. Different forms of Chantix DMFs exist exist since differing nations have different regulations, such as Chantix USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Chantix DMF submitted to regulatory agencies in the US is known as a USDMF. Chantix USDMF includes data on Chantix's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Chantix USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Chantix suppliers with USDMF on PharmaCompass.
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