Apex Healthcare Limited: ISO 9001:2008, WHO-GMP, US FDA-audited manufacturer & exporter of APIs, bulk drugs, and formulations.
01 1Apex Healthcare Limited
02 1Cambrex Corporation
03 1Dishman Carbogen Amcis
04 1Erregierre SpA
05 1Kreative Organics
01 2BISACODYL
02 2BISACODYL USP
03 1BISACODYL USP-EP
01 3India
02 1Italy
03 1U.S.A
01 5Active
01 5Blank
Apex Healthcare Limited: ISO 9001:2008, WHO-GMP, US FDA-audited manufacturer & exporter of APIs, bulk drugs, and formulations.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 36474
Submission : 2022-01-27
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 2248
Submission : 1974-03-21
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 20476
Submission : 2007-04-24
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 14947
Submission : 2000-06-29
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 16058
Submission : 2002-06-28
Status : Active
Type : II
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A Pyrilax manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Pyrilax, including repackagers and relabelers. The FDA regulates Pyrilax manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Pyrilax 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 Pyrilax DMF (Drug Master File) is a document detailing the whole manufacturing process of Pyrilax active pharmaceutical ingredient (API) in detail. Different forms of Pyrilax DMFs exist exist since differing nations have different regulations, such as Pyrilax USDMF, ASMF (EDMF), JDMF, CDMF, etc.
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