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DRUG PRODUCT COMPOSITIONS
DOSAGE - SUSPENSION, EXTENDED RELEASE;SUBCUTA...DOSAGE - SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS - 2MG/0.85ML (2MG/0.85ML)
USFDA APPLICATION NUMBER - 209210
DOSAGE - INJECTABLE;SUBCUTANEOUS - 300MCG/1.2...DOSAGE - INJECTABLE;SUBCUTANEOUS - 300MCG/1.2ML (250MCG/ML)
USFDA APPLICATION NUMBER - 21773
DOSAGE - INJECTABLE;SUBCUTANEOUS - 600MCG/2.4...DOSAGE - INJECTABLE;SUBCUTANEOUS - 600MCG/2.4ML (250MCG/ML)
USFDA APPLICATION NUMBER - 21773
DOSAGE - FOR SUSPENSION, EXTENDED RELEASE;SUB...DOSAGE - FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS - 2MG/VIAL
USFDA APPLICATION NUMBER - 22200
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ABOUT THIS PAGE
A bydureon manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of bydureon, including repackagers and relabelers. The FDA regulates bydureon manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. bydureon API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
A bydureon supplier is an individual or a company that provides bydureon active pharmaceutical ingredient (API) or bydureon finished formulations upon request. The bydureon suppliers may include bydureon API manufacturers, exporters, distributors and traders.
click here to find a list of bydureon suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A bydureon DMF (Drug Master File) is a document detailing the whole manufacturing process of bydureon active pharmaceutical ingredient (API) in detail. Different forms of bydureon DMFs exist exist since differing nations have different regulations, such as bydureon USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A bydureon DMF submitted to regulatory agencies in the US is known as a USDMF. bydureon USDMF includes data on bydureon's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The bydureon USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of bydureon suppliers with USDMF on PharmaCompass.
bydureon Active pharmaceutical ingredient (API) is produced in GMP-certified manufacturing facility.
GMP stands for Good Manufacturing Practices, which is a system used in the pharmaceutical industry to make sure that goods are regularly produced and monitored in accordance with quality standards. The FDA’s current Good Manufacturing Practices requirements are referred to as cGMP or current GMP which indicates that the company follows the most recent GMP specifications. The World Health Organization (WHO) has its own set of GMP guidelines, called the WHO GMP. Different countries can also set their own guidelines for GMP like China (Chinese GMP) or the EU (EU GMP).
PharmaCompass offers a list of bydureon GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, API price, and more, enabling you to easily find the right bydureon GMP manufacturer or bydureon GMP API supplier for your needs.
A bydureon CoA (Certificate of Analysis) is a formal document that attests to bydureon's compliance with bydureon specifications and serves as a tool for batch-level quality control.
bydureon CoA mostly includes findings from lab analyses of a specific batch. For each bydureon CoA document that a company creates, the USFDA specifies specific requirements, such as supplier information, material identification, transportation data, evidence of conformity and signature data.
bydureon may be tested according to a variety of international standards, such as European Pharmacopoeia (bydureon EP), bydureon JP (Japanese Pharmacopeia) and the US Pharmacopoeia (bydureon USP).
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