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