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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 Exenatide Synthetic manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Exenatide Synthetic, including repackagers and relabelers. The FDA regulates Exenatide Synthetic manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Exenatide Synthetic 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 Exenatide Synthetic supplier is an individual or a company that provides Exenatide Synthetic active pharmaceutical ingredient (API) or Exenatide Synthetic finished formulations upon request. The Exenatide Synthetic suppliers may include Exenatide Synthetic API manufacturers, exporters, distributors and traders.
click here to find a list of Exenatide Synthetic suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Exenatide Synthetic DMF (Drug Master File) is a document detailing the whole manufacturing process of Exenatide Synthetic active pharmaceutical ingredient (API) in detail. Different forms of Exenatide Synthetic DMFs exist exist since differing nations have different regulations, such as Exenatide Synthetic USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Exenatide Synthetic DMF submitted to regulatory agencies in the US is known as a USDMF. Exenatide Synthetic USDMF includes data on Exenatide Synthetic's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Exenatide Synthetic USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Exenatide Synthetic suppliers with USDMF on PharmaCompass.
Exenatide Synthetic 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 Exenatide Synthetic 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 Exenatide Synthetic GMP manufacturer or Exenatide Synthetic GMP API supplier for your needs.
A Exenatide Synthetic CoA (Certificate of Analysis) is a formal document that attests to Exenatide Synthetic's compliance with Exenatide Synthetic specifications and serves as a tool for batch-level quality control.
Exenatide Synthetic CoA mostly includes findings from lab analyses of a specific batch. For each Exenatide Synthetic 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.
Exenatide Synthetic may be tested according to a variety of international standards, such as European Pharmacopoeia (Exenatide Synthetic EP), Exenatide Synthetic JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Exenatide Synthetic USP).
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