Cohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.
01 1Cohance Lifesciences
02 1Angelini Pharma
03 1Arevipharma
04 1Boehringer Ingelheim GmbH
05 1Corden Pharma Bergamo S.p.A
06 1FDC
07 1Fresenius Kabi Oncology Limited
08 1Hetero Drugs
09 1Innovare Labs
10 1KLIO Pharma
11 1Lupin Ltd
12 1Piramal Pharma Solutions
13 1Raks Pharma
14 1Roche Diagnostics GmbH
15 1Sun Pharmaceutical Industries Limited
16 1Syn-Tech Chem. & Pharm
17 2Zhejiang Apeloa Jiayuan Pharmaceutical
18 1Blank
01 11METAXALONE
02 1METAXALONE API
03 7METAXALONE USP
01 2China
02 3Germany
03 9India
04 2Italy
05 1Taiwan
06 1U.S.A
07 1Blank
01 11Active
02 8Inactive
01 8Complete
02 11Blank
Cohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.
GDUFA
DMF Review : Complete
Rev. Date : 2016-04-06
Pay. Date : 2015-09-22
DMF Number : 21251
Submission : 2008-01-15
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-02-26
Pay. Date : 2013-02-11
DMF Number : 15100
Submission : 2000-10-19
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-02-26
Pay. Date : 2013-02-04
DMF Number : 15087
Submission : 2000-10-11
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2014-07-14
Pay. Date : 2014-03-24
DMF Number : 28062
Submission : 2014-02-28
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2022-03-29
Pay. Date : 2022-03-09
DMF Number : 36167
Submission : 2021-09-30
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 27105
Submission : 2013-04-26
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 23980
Submission : 2010-07-19
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 31859
Submission : 2017-10-24
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2014-06-16
Pay. Date : 2014-03-06
DMF Number : 24631
Submission : 2011-02-04
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-12-05
Pay. Date : 2013-08-01
DMF Number : 25533
Submission : 2011-11-21
Status : Active
Type : II
A Skelaxin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Skelaxin, including repackagers and relabelers. The FDA regulates Skelaxin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Skelaxin 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 Skelaxin manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Skelaxin supplier is an individual or a company that provides Skelaxin active pharmaceutical ingredient (API) or Skelaxin finished formulations upon request. The Skelaxin suppliers may include Skelaxin API manufacturers, exporters, distributors and traders.
click here to find a list of Skelaxin suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Skelaxin DMF (Drug Master File) is a document detailing the whole manufacturing process of Skelaxin active pharmaceutical ingredient (API) in detail. Different forms of Skelaxin DMFs exist exist since differing nations have different regulations, such as Skelaxin USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Skelaxin DMF submitted to regulatory agencies in the US is known as a USDMF. Skelaxin USDMF includes data on Skelaxin's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Skelaxin USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Skelaxin suppliers with USDMF on PharmaCompass.
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