Symbiotec: Global API manufacturer, specializing in Cortico-Steroids & Steroid-Hormone APIs.
01 2Symbiotec Pharmalab
02 3Coral Drugs Private Limited
03 2Axplora
04 2Seqens
05 4Aarti Pharmalabs
06 1TAPI Technology & API Services
07 1Aurisco Pharmaceutical
08 2Breathgreen Pharmaceuticals
09 4Cipla
10 1Curia
11 1Halcyon Labs Private Limited
12 2Henan Lihua Pharmaceutical
13 2Hovione
14 1Hunan Yuxin Pharmaceutical
15 1Industriale Chimica
16 1NEWCHEM SPA
17 2Sterling Spa
18 1Symbiotica
19 1Taro Pharmaceutical Industries
20 2Tianjin Tianfa Pharmaceutical Import & Export
Symbiotec: Global API manufacturer, specializing in Cortico-Steroids & Steroid-Hormone APIs.
GDUFA
DMF Review : Complete
Rev. Date : 2014-05-01
Pay. Date : 2014-04-29
DMF Number : 20684
Submission : 2007-07-12
Status :
Type : II
Coral's API range includes Corticosteroids, Antihistamines. Hormones and Antineoplastics.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 30852
Submission : 2016-09-09
Status :
Type : II
Axplora is your partner of choice for complex APIs.
GDUFA
DMF Review : Complete
Rev. Date : 2014-03-31
Pay. Date : 2014-03-20
DMF Number : 22319
Submission : 2008-12-18
Status :
Type : II
Seqens is an integrated global leader in pharmaceutical solutions & specialty ingredients, & custom-made solutions to our customers.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 15187
Submission : 2000-12-07
Status :
Type : II
Aarti Pharmalabs is a partner of choice for APIs & Intermediates and the largest Indian manufacturer of Xanthine Derivatives.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 21334
Submission : 2008-02-12
Status :
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 : 2014-03-10
Pay. Date : 2012-11-09
DMF Number : 15063
Submission : 2000-09-29
Status :
Type : II
Symbiotec: Global API manufacturer, specializing in Cortico-Steroids & Steroid-Hormone APIs.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 25448
Submission : 2011-10-31
Status :
Type : II
Coral's API range includes Corticosteroids, Antihistamines. Hormones and Antineoplastics.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 35686
Submission : 2021-07-14
Status :
Type : II
Coral's API range includes Corticosteroids, Antihistamines. Hormones and Antineoplastics.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 31076
Submission : 2016-11-25
Status :
Type : II
Axplora is your partner of choice for complex APIs.
GDUFA
DMF Review : Complete
Rev. Date : 2019-12-09
Pay. Date : 2019-09-18
DMF Number : 33446
Submission : 2019-03-11
Status :
Type : II
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A 141646-00-6 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of 141646-00-6, including repackagers and relabelers. The FDA regulates 141646-00-6 manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. 141646-00-6 API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
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A 141646-00-6 DMF (Drug Master File) is a document detailing the whole manufacturing process of 141646-00-6 active pharmaceutical ingredient (API) in detail. Different forms of 141646-00-6 DMFs exist exist since differing nations have different regulations, such as 141646-00-6 USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A 141646-00-6 DMF submitted to regulatory agencies in the US is known as a USDMF. 141646-00-6 USDMF includes data on 141646-00-6's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The 141646-00-6 USDMF is kept confidential to protect the manufacturer’s intellectual property.
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