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