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API SUPPLIERS
Axplora- The partner of choice for complex APIs.
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USDMF
Axplora- The partner of choice for complex APIs.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 27293
Submission : 2013-07-03
Status :
Type : II
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Axplora- The partner of choice for complex APIs.
Tirofiban Hydrochloride Monohydrate
About the Company : Axplora, created from the merger of Farmabios, Novasep & PharmaZell, is a leading API manufacturing partner to the world’s leading pharma & biotech companies, delivering top-qual...
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ABOUT THIS PAGE
A Tirofiban Hydrochloride Monohydrate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Tirofiban Hydrochloride Monohydrate, including repackagers and relabelers. The FDA regulates Tirofiban Hydrochloride Monohydrate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Tirofiban Hydrochloride Monohydrate API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
click here to find a list of Tirofiban Hydrochloride Monohydrate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Tirofiban Hydrochloride Monohydrate supplier is an individual or a company that provides Tirofiban Hydrochloride Monohydrate active pharmaceutical ingredient (API) or Tirofiban Hydrochloride Monohydrate finished formulations upon request. The Tirofiban Hydrochloride Monohydrate suppliers may include Tirofiban Hydrochloride Monohydrate API manufacturers, exporters, distributors and traders.
click here to find a list of Tirofiban Hydrochloride Monohydrate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Tirofiban Hydrochloride Monohydrate DMF (Drug Master File) is a document detailing the whole manufacturing process of Tirofiban Hydrochloride Monohydrate active pharmaceutical ingredient (API) in detail. Different forms of Tirofiban Hydrochloride Monohydrate DMFs exist exist since differing nations have different regulations, such as Tirofiban Hydrochloride Monohydrate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Tirofiban Hydrochloride Monohydrate DMF submitted to regulatory agencies in the US is known as a USDMF. Tirofiban Hydrochloride Monohydrate USDMF includes data on Tirofiban Hydrochloride Monohydrate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Tirofiban Hydrochloride Monohydrate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Tirofiban Hydrochloride Monohydrate suppliers with USDMF on PharmaCompass.
Tirofiban Hydrochloride Monohydrate 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 Tirofiban Hydrochloride Monohydrate 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 Tirofiban Hydrochloride Monohydrate GMP manufacturer or Tirofiban Hydrochloride Monohydrate GMP API supplier for your needs.
A Tirofiban Hydrochloride Monohydrate CoA (Certificate of Analysis) is a formal document that attests to Tirofiban Hydrochloride Monohydrate's compliance with Tirofiban Hydrochloride Monohydrate specifications and serves as a tool for batch-level quality control.
Tirofiban Hydrochloride Monohydrate CoA mostly includes findings from lab analyses of a specific batch. For each Tirofiban Hydrochloride Monohydrate 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.
Tirofiban Hydrochloride Monohydrate may be tested according to a variety of international standards, such as European Pharmacopoeia (Tirofiban Hydrochloride Monohydrate EP), Tirofiban Hydrochloride Monohydrate JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Tirofiban Hydrochloride Monohydrate USP).
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