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Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.
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EU-WC
NDC
ASMF, CN
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
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Nuray is an expert in the synthesis of Niche novel APIs, the first to launch Generics, NCEs, Advanced Intermediates // USFDA certified.
Cohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.
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TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
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USDMF
Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.
GDUFA
DMF Review : Complete
Rev. Date : 2023-08-22
Pay. Date : 2023-07-17
DMF Number : 37593
Submission : 2022-12-28
Status :
Type : II
With Fermion, start the journey of your innovative API.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 4570
Submission : 1982-05-21
Status :
Type : II
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 7459
Submission : 1988-05-05
Status :
Type : II
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
GDUFA
DMF Review : Complete
Rev. Date : 2012-12-27
Pay. Date : 2012-11-13
DMF Number : 16459
Submission : 2003-03-10
Status :
Type : II
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Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.
Trazodone Hydrochloride IH/USP
Date of Issue : 2022-07-08
Valid Till : 2025-06-28
Written Confirmation Number : WC-0024
Address of the Firm : Plot No-8, Jawaharlal Nehru Pharamacity,Tadi (v), Parawada (M), Vishakapatnam Di...
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ABOUT THIS PAGE
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PharmaCompass offers a list of Trazodone Hydrochloride API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right Trazodone Hydrochloride manufacturer or Trazodone Hydrochloride supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Trazodone Hydrochloride manufacturer or Trazodone Hydrochloride supplier.
PharmaCompass also assists you with knowing the Trazodone Hydrochloride API Price utilized in the formulation of products. Trazodone Hydrochloride API Price is not always fixed or binding as the Trazodone Hydrochloride Price is obtained through a variety of data sources. The Trazodone Hydrochloride Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Trazodone manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Trazodone, including repackagers and relabelers. The FDA regulates Trazodone manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Trazodone 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 Trazodone manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Trazodone supplier is an individual or a company that provides Trazodone active pharmaceutical ingredient (API) or Trazodone finished formulations upon request. The Trazodone suppliers may include Trazodone API manufacturers, exporters, distributors and traders.
click here to find a list of Trazodone suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Trazodone DMF (Drug Master File) is a document detailing the whole manufacturing process of Trazodone active pharmaceutical ingredient (API) in detail. Different forms of Trazodone DMFs exist exist since differing nations have different regulations, such as Trazodone USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Trazodone DMF submitted to regulatory agencies in the US is known as a USDMF. Trazodone USDMF includes data on Trazodone's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Trazodone USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Trazodone 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 Trazodone Drug Master File in Japan (Trazodone JDMF) empowers Trazodone 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 Trazodone JDMF during the approval evaluation for pharmaceutical products. At the time of Trazodone 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 Trazodone suppliers with JDMF 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 Trazodone Drug Master File in Korea (Trazodone KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Trazodone. The MFDS reviews the Trazodone KDMF as part of the drug registration process and uses the information provided in the Trazodone KDMF to evaluate the safety and efficacy of the drug.
After submitting a Trazodone 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 Trazodone API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Trazodone suppliers with KDMF on PharmaCompass.
A Trazodone CEP of the European Pharmacopoeia monograph is often referred to as a Trazodone Certificate of Suitability (COS). The purpose of a Trazodone CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Trazodone EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Trazodone to their clients by showing that a Trazodone CEP has been issued for it. The manufacturer submits a Trazodone CEP (COS) as part of the market authorization procedure, and it takes on the role of a Trazodone CEP holder for the record. Additionally, the data presented in the Trazodone CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Trazodone DMF.
A Trazodone CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Trazodone 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 Trazodone suppliers with CEP (COS) on PharmaCompass.
A Trazodone written confirmation (Trazodone WC) is an official document issued by a regulatory agency to a Trazodone manufacturer, verifying that the manufacturing facility of a Trazodone active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Trazodone APIs or Trazodone finished pharmaceutical products to another nation, regulatory agencies frequently require a Trazodone WC (written confirmation) as part of the regulatory process.
click here to find a list of Trazodone suppliers with Written Confirmation (WC) 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 Trazodone as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Trazodone 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 Trazodone 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 Trazodone and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Trazodone NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Trazodone suppliers with NDC on PharmaCompass.
Trazodone 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 Trazodone 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 Trazodone GMP manufacturer or Trazodone GMP API supplier for your needs.
A Trazodone CoA (Certificate of Analysis) is a formal document that attests to Trazodone's compliance with Trazodone specifications and serves as a tool for batch-level quality control.
Trazodone CoA mostly includes findings from lab analyses of a specific batch. For each Trazodone 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.
Trazodone may be tested according to a variety of international standards, such as European Pharmacopoeia (Trazodone EP), Trazodone JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Trazodone USP).
