Alchem offers Phytochemical APIs for Pharmaceuticals, Cosmetics and Nutraceuticals// FDA-inspected and EU-GMP certified.
01 1Alchem International Private Ltd
02 1Phytex Australia
03 2Boehringer Ingelheim GmbH
04 1Vital Laboratories Private Limited
Alchem offers Phytochemical APIs for Pharmaceuticals, Cosmetics and Nutraceuticals// FDA-inspected and EU-GMP certified.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 30721
Submission : 2016-07-06
Status :
Type : II
Experts in producing high-quality APIs from natural sources, specializing in advanced extraction and isolation techniques.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 7415
Submission : 1988-03-30
Status :
Type : II
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A Hyoscine HBr manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Hyoscine HBr, including repackagers and relabelers. The FDA regulates Hyoscine HBr manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Hyoscine HBr 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 Hyoscine HBr DMF (Drug Master File) is a document detailing the whole manufacturing process of Hyoscine HBr active pharmaceutical ingredient (API) in detail. Different forms of Hyoscine HBr DMFs exist exist since differing nations have different regulations, such as Hyoscine HBr USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Hyoscine HBr DMF submitted to regulatory agencies in the US is known as a USDMF. Hyoscine HBr USDMF includes data on Hyoscine HBr's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Hyoscine HBr USDMF is kept confidential to protect the manufacturer’s intellectual property.
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We have 4 companies offering Hyoscine HBr
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