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API SUPPLIERS
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
Metrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.
NDC 
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USDMF
Metrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 35515
Submission : 2021-02-20
Status :
Type : II
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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, ...
Metrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.
About the Company : Established in 2004, Metrochem API is one of the fastest-growing APIs, pellets & intermediates manufacturers. It has 6 dedicated manufacturing facilities for its 3 core product gro...
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Rochem, your partner in developing, sourcing, and supplying pharmaceutical & animal health ingredients of Chinese origin.
Dosage Form : Tablet
Grade : Oral
Application : Fillers, Diluents & Binders, Taste Masking
Excipient Details : Mannitol is used as a filler, bulking agent and taste masking agent in ODT formulations such as tablets.
Faran Shimi: Leading producer of high-quality APIs & alkaloid opiates, serving major pharmaceutical companies across the Middle East.
Dosage Form : Tablet
Grade : Oral
Application : Co-Processed Excipients
Excipient Details : Mannitol is a co-processed excipient with superior compactibility, lower disintegration time, and hygroscopicity.
Pfanstiehl, a global leader in the manufacture of cGMP high purity, low endotoxin, low metals (HPLE-LM)TM injectable grade excipients.
Dosage Form : Injectable / Parenteral, Tablet
Grade : Parenteral, Oral
Application : Fillers, Diluents & Binders, Parenteral, Thickeners and Stabilizers
Excipient Details : D-mannitol protects proteins from denaturation & degradation. It is also used as a stabilizer in liquid formulations & as a bulking agent in tablets.
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PharmaCompass offers a list of Tedizolid API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right Tedizolid manufacturer or Tedizolid supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Tedizolid manufacturer or Tedizolid supplier.
PharmaCompass also assists you with knowing the Tedizolid API Price utilized in the formulation of products. Tedizolid API Price is not always fixed or binding as the Tedizolid Price is obtained through a variety of data sources. The Tedizolid Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Tedizolid Phosphate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Tedizolid Phosphate, including repackagers and relabelers. The FDA regulates Tedizolid Phosphate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Tedizolid Phosphate 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 Tedizolid Phosphate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Tedizolid Phosphate supplier is an individual or a company that provides Tedizolid Phosphate active pharmaceutical ingredient (API) or Tedizolid Phosphate finished formulations upon request. The Tedizolid Phosphate suppliers may include Tedizolid Phosphate API manufacturers, exporters, distributors and traders.
click here to find a list of Tedizolid Phosphate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Tedizolid Phosphate DMF (Drug Master File) is a document detailing the whole manufacturing process of Tedizolid Phosphate active pharmaceutical ingredient (API) in detail. Different forms of Tedizolid Phosphate DMFs exist exist since differing nations have different regulations, such as Tedizolid Phosphate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Tedizolid Phosphate DMF submitted to regulatory agencies in the US is known as a USDMF. Tedizolid Phosphate USDMF includes data on Tedizolid Phosphate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Tedizolid Phosphate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Tedizolid Phosphate suppliers with USDMF 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 Tedizolid Phosphate as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Tedizolid Phosphate 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 Tedizolid Phosphate 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 Tedizolid Phosphate and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Tedizolid Phosphate NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Tedizolid Phosphate suppliers with NDC on PharmaCompass.
Tedizolid Phosphate 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 Tedizolid Phosphate 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 Tedizolid Phosphate GMP manufacturer or Tedizolid Phosphate GMP API supplier for your needs.
A Tedizolid Phosphate CoA (Certificate of Analysis) is a formal document that attests to Tedizolid Phosphate's compliance with Tedizolid Phosphate specifications and serves as a tool for batch-level quality control.
Tedizolid Phosphate CoA mostly includes findings from lab analyses of a specific batch. For each Tedizolid Phosphate 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.
Tedizolid Phosphate may be tested according to a variety of international standards, such as European Pharmacopoeia (Tedizolid Phosphate EP), Tedizolid Phosphate JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Tedizolid Phosphate USP).
