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ABOUT THIS PAGE
A Tianeptine Sodium manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Tianeptine Sodium, including repackagers and relabelers. The FDA regulates Tianeptine Sodium manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Tianeptine Sodium 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 Tianeptine Sodium manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Tianeptine Sodium supplier is an individual or a company that provides Tianeptine Sodium active pharmaceutical ingredient (API) or Tianeptine Sodium finished formulations upon request. The Tianeptine Sodium suppliers may include Tianeptine Sodium API manufacturers, exporters, distributors and traders.
click here to find a list of Tianeptine Sodium suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Tianeptine Sodium DMF (Drug Master File) is a document detailing the whole manufacturing process of Tianeptine Sodium active pharmaceutical ingredient (API) in detail. Different forms of Tianeptine Sodium DMFs exist exist since differing nations have different regulations, such as Tianeptine Sodium USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Tianeptine Sodium DMF submitted to regulatory agencies in the US is known as a USDMF. Tianeptine Sodium USDMF includes data on Tianeptine Sodium's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Tianeptine Sodium USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Tianeptine Sodium suppliers with USDMF on PharmaCompass.
In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a Tianeptine Sodium Drug Master File in Korea (Tianeptine Sodium KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Tianeptine Sodium. The MFDS reviews the Tianeptine Sodium KDMF as part of the drug registration process and uses the information provided in the Tianeptine Sodium KDMF to evaluate the safety and efficacy of the drug.
After submitting a Tianeptine Sodium KDMF to the MFDS, the registered manufacturer can provide importers or distributors with the registration number without revealing confidential information to Korean business partners. Applicants seeking to register their Tianeptine Sodium API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Tianeptine Sodium suppliers with KDMF on PharmaCompass.
A Tianeptine Sodium CEP of the European Pharmacopoeia monograph is often referred to as a Tianeptine Sodium Certificate of Suitability (COS). The purpose of a Tianeptine Sodium CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Tianeptine Sodium EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Tianeptine Sodium to their clients by showing that a Tianeptine Sodium CEP has been issued for it. The manufacturer submits a Tianeptine Sodium CEP (COS) as part of the market authorization procedure, and it takes on the role of a Tianeptine Sodium CEP holder for the record. Additionally, the data presented in the Tianeptine Sodium CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Tianeptine Sodium DMF.
A Tianeptine Sodium CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Tianeptine Sodium 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 Tianeptine Sodium 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 Tianeptine Sodium as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Tianeptine Sodium 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 Tianeptine Sodium 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 Tianeptine Sodium and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Tianeptine Sodium NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Tianeptine Sodium suppliers with NDC on PharmaCompass.
Tianeptine Sodium 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 Tianeptine Sodium 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 Tianeptine Sodium GMP manufacturer or Tianeptine Sodium GMP API supplier for your needs.
A Tianeptine Sodium CoA (Certificate of Analysis) is a formal document that attests to Tianeptine Sodium's compliance with Tianeptine Sodium specifications and serves as a tool for batch-level quality control.
Tianeptine Sodium CoA mostly includes findings from lab analyses of a specific batch. For each Tianeptine Sodium 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.
Tianeptine Sodium may be tested according to a variety of international standards, such as European Pharmacopoeia (Tianeptine Sodium EP), Tianeptine Sodium JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Tianeptine Sodium USP).
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