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