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API SUPPLIERS
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
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USDMF
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LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
About the Company : LGM Pharma is a global leader in sourcing hard-to-find APIs and intermediates for the pharmaceutical and biotech industries. LGM is also a full service CDMO providing formulation, ...
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Drugs in Development
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DOSAGE - SOLUTION;INJECTION - EQ 3.75MG BASE/...DOSAGE - SOLUTION;INJECTION - EQ 3.75MG BASE/15ML (EQ 0.25MG BASE/ML)
USFDA APPLICATION NUMBER - 20912
DOSAGE - SOLUTION;INTRAVENOUS - EQ 12.5MG BAS...DOSAGE - SOLUTION;INTRAVENOUS - EQ 12.5MG BASE/250ML (EQ 0.05MG BASE/ML)
USFDA APPLICATION NUMBER - 20913
DOSAGE - SOLUTION;INTRAVENOUS - EQ 5MG BASE/1...DOSAGE - SOLUTION;INTRAVENOUS - EQ 5MG BASE/100ML (EQ 0.05MG BASE/ML)
USFDA APPLICATION NUMBER - 20913
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ABOUT THIS PAGE
A Tirofiban manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Tirofiban, including repackagers and relabelers. The FDA regulates Tirofiban manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Tirofiban 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 manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Tirofiban supplier is an individual or a company that provides Tirofiban active pharmaceutical ingredient (API) or Tirofiban finished formulations upon request. The Tirofiban suppliers may include Tirofiban API manufacturers, exporters, distributors and traders.
click here to find a list of Tirofiban suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Tirofiban DMF (Drug Master File) is a document detailing the whole manufacturing process of Tirofiban active pharmaceutical ingredient (API) in detail. Different forms of Tirofiban DMFs exist exist since differing nations have different regulations, such as Tirofiban USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Tirofiban DMF submitted to regulatory agencies in the US is known as a USDMF. Tirofiban USDMF includes data on Tirofiban's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Tirofiban USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Tirofiban suppliers with USDMF on PharmaCompass.
A Tirofiban written confirmation (Tirofiban WC) is an official document issued by a regulatory agency to a Tirofiban manufacturer, verifying that the manufacturing facility of a Tirofiban active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Tirofiban APIs or Tirofiban finished pharmaceutical products to another nation, regulatory agencies frequently require a Tirofiban WC (written confirmation) as part of the regulatory process.
click here to find a list of Tirofiban suppliers with Written Confirmation (WC) on PharmaCompass.
National Drug Code is a comprehensive database maintained by the FDA that contains information on all drugs marketed in the US. This directory includes information about finished drug products, unfinished drug products, and compounded drug products, including those containing Tirofiban as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Tirofiban API and other APIs are published in this directory by the FDA.
The NDC unfinished drugs database includes product listing information submitted for all unfinished drugs, such as active pharmaceutical ingredients (APIs), drugs intended for further processing and bulk drug substances for compounding.
Pharmaceutical companies that manufacture Tirofiban as an active pharmaceutical ingredient (API) must furnish the FDA with an updated record of all drugs that they produce, prepare, propagate, compound, or process for commercial distribution in the US at their facilities.
The NDC directory also contains data on finished compounded human drug products that contain Tirofiban and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Tirofiban NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Tirofiban suppliers with NDC on PharmaCompass.
Tirofiban 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 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 GMP manufacturer or Tirofiban GMP API supplier for your needs.
A Tirofiban CoA (Certificate of Analysis) is a formal document that attests to Tirofiban's compliance with Tirofiban specifications and serves as a tool for batch-level quality control.
Tirofiban CoA mostly includes findings from lab analyses of a specific batch. For each Tirofiban 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 may be tested according to a variety of international standards, such as European Pharmacopoeia (Tirofiban EP), Tirofiban JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Tirofiban USP).
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