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