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ABOUT THIS PAGE
A Spectinomycin sulfate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Spectinomycin sulfate, including repackagers and relabelers. The FDA regulates Spectinomycin sulfate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Spectinomycin sulfate 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 Spectinomycin sulfate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Spectinomycin sulfate supplier is an individual or a company that provides Spectinomycin sulfate active pharmaceutical ingredient (API) or Spectinomycin sulfate finished formulations upon request. The Spectinomycin sulfate suppliers may include Spectinomycin sulfate API manufacturers, exporters, distributors and traders.
click here to find a list of Spectinomycin sulfate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Spectinomycin sulfate DMF (Drug Master File) is a document detailing the whole manufacturing process of Spectinomycin sulfate active pharmaceutical ingredient (API) in detail. Different forms of Spectinomycin sulfate DMFs exist exist since differing nations have different regulations, such as Spectinomycin sulfate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Spectinomycin sulfate DMF submitted to regulatory agencies in the US is known as a USDMF. Spectinomycin sulfate USDMF includes data on Spectinomycin sulfate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Spectinomycin sulfate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Spectinomycin sulfate suppliers with USDMF on PharmaCompass.
A Spectinomycin sulfate CEP of the European Pharmacopoeia monograph is often referred to as a Spectinomycin sulfate Certificate of Suitability (COS). The purpose of a Spectinomycin sulfate CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Spectinomycin sulfate EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Spectinomycin sulfate to their clients by showing that a Spectinomycin sulfate CEP has been issued for it. The manufacturer submits a Spectinomycin sulfate CEP (COS) as part of the market authorization procedure, and it takes on the role of a Spectinomycin sulfate CEP holder for the record. Additionally, the data presented in the Spectinomycin sulfate CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Spectinomycin sulfate DMF.
A Spectinomycin sulfate CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Spectinomycin sulfate CEPs may be accepted in nations that are not members of the Ph. Eur. at the discretion of the authorities there.
click here to find a list of Spectinomycin sulfate suppliers with CEP (COS) 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 Spectinomycin sulfate as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Spectinomycin sulfate 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 Spectinomycin sulfate 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 Spectinomycin sulfate and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Spectinomycin sulfate NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Spectinomycin sulfate suppliers with NDC on PharmaCompass.
Spectinomycin sulfate 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 Spectinomycin sulfate 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 Spectinomycin sulfate GMP manufacturer or Spectinomycin sulfate GMP API supplier for your needs.
A Spectinomycin sulfate CoA (Certificate of Analysis) is a formal document that attests to Spectinomycin sulfate's compliance with Spectinomycin sulfate specifications and serves as a tool for batch-level quality control.
Spectinomycin sulfate CoA mostly includes findings from lab analyses of a specific batch. For each Spectinomycin sulfate 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.
Spectinomycin sulfate may be tested according to a variety of international standards, such as European Pharmacopoeia (Spectinomycin sulfate EP), Spectinomycin sulfate JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Spectinomycin sulfate USP).
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