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USDMF
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13442
Submission : 1998-09-01
Status :
Type : II
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13485
Submission : 1998-09-01
Status :
Type : II
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REF. STANDARDS & IMPURITIES
ABOUT THIS PAGE
A Streptomycin Sulfate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Streptomycin Sulfate, including repackagers and relabelers. The FDA regulates Streptomycin Sulfate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Streptomycin 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 Streptomycin Sulfate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Streptomycin Sulfate supplier is an individual or a company that provides Streptomycin Sulfate active pharmaceutical ingredient (API) or Streptomycin Sulfate finished formulations upon request. The Streptomycin Sulfate suppliers may include Streptomycin Sulfate API manufacturers, exporters, distributors and traders.
click here to find a list of Streptomycin Sulfate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Streptomycin Sulfate DMF (Drug Master File) is a document detailing the whole manufacturing process of Streptomycin Sulfate active pharmaceutical ingredient (API) in detail. Different forms of Streptomycin Sulfate DMFs exist exist since differing nations have different regulations, such as Streptomycin Sulfate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Streptomycin Sulfate DMF submitted to regulatory agencies in the US is known as a USDMF. Streptomycin Sulfate USDMF includes data on Streptomycin Sulfate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Streptomycin Sulfate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Streptomycin Sulfate suppliers with USDMF on PharmaCompass.
The Pharmaceuticals and Medical Devices Agency (PMDA) established the Japan Drug Master File (JDMF), also known as the Master File (MF), to permit Japanese and foreign manufacturers of drug substances, intermediates, excipients, raw materials, and packaging materials (‘Products’) to voluntarily register confidential information about the production and management of their products in Japan.
The Streptomycin Sulfate Drug Master File in Japan (Streptomycin Sulfate JDMF) empowers Streptomycin Sulfate API manufacturers to present comprehensive information (e.g., production methods, data, etc.) to the review authority, i.e., PMDA (Pharmaceuticals & Medical Devices Agency).
PMDA reviews the Streptomycin Sulfate JDMF during the approval evaluation for pharmaceutical products. At the time of Streptomycin Sulfate JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.
click here to find a list of Streptomycin Sulfate suppliers with JDMF on PharmaCompass.
A Streptomycin Sulfate CEP of the European Pharmacopoeia monograph is often referred to as a Streptomycin Sulfate Certificate of Suitability (COS). The purpose of a Streptomycin Sulfate CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Streptomycin Sulfate EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Streptomycin Sulfate to their clients by showing that a Streptomycin Sulfate CEP has been issued for it. The manufacturer submits a Streptomycin Sulfate CEP (COS) as part of the market authorization procedure, and it takes on the role of a Streptomycin Sulfate CEP holder for the record. Additionally, the data presented in the Streptomycin Sulfate CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Streptomycin Sulfate DMF.
A Streptomycin Sulfate CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Streptomycin 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 Streptomycin 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 Streptomycin Sulfate as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Streptomycin 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 Streptomycin 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 Streptomycin Sulfate and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Streptomycin Sulfate NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Streptomycin Sulfate suppliers with NDC on PharmaCompass.
Streptomycin 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 Streptomycin 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 Streptomycin Sulfate GMP manufacturer or Streptomycin Sulfate GMP API supplier for your needs.
A Streptomycin Sulfate CoA (Certificate of Analysis) is a formal document that attests to Streptomycin Sulfate's compliance with Streptomycin Sulfate specifications and serves as a tool for batch-level quality control.
Streptomycin Sulfate CoA mostly includes findings from lab analyses of a specific batch. For each Streptomycin 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.
Streptomycin Sulfate may be tested according to a variety of international standards, such as European Pharmacopoeia (Streptomycin Sulfate EP), Streptomycin Sulfate JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Streptomycin Sulfate USP).
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