Synopsis
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DRUG PRODUCT COMPOSITIONS0
Weekly News Recap #Phispers
API SUPPLIERS
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
Jai Radhe Sales is your partner for all your sourcing needs.
HRV Pharma - Market Expansion Leader in Pharmaceuticals.
Octavius Pharma has been empowering lives since 1980 by providing quality products like DC granules, APIs and FDFs.
Tenatra connects Indian manufacturers with global buyers through active partners in Germany, Switzerland, Belgium, Spain & Turkey.
Zeon Pharma is a manufacturer and supplier of APIs & Intermediates.
Harika Drugs has been providing a qualitative range of Bulk Drugs/ APIs since 1993.
Willow Birch Pharma delivers trusted, high-quality APIs nationwide with unmatched service, compliance, and competitive value.
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USDMF
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LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
About the Company : LGM Pharma is a global leader in sourcing APIs, including hard-to-find drug substances, for pharmaceutical and biotech industries. LGM also operates as a full-service drug product ...
Jai Radhe Sales is your partner for all your sourcing needs.
About the Company : Jai Radhe Sales, founded in 1999, is a global distributor specializing in high-quality pharmaceutical ingredients from India. It offers complete sourcing solutions, technical and r...
HRV Pharma - Market Expansion Leader in Pharmaceuticals.
About the Company : HRV Pharma is a global manufacturer, seller, and exporter of APIs, intermediates, pellets, food-grade chemicals, food additives, and food ingredients. The company provides sourcing...
Octavius Pharma has been empowering lives since 1980 by providing quality products like DC granules, APIs and FDFs.
About the Company : Octavius Pharma is a global leader in Directly Compressible Granules with over 45 years of experience in formulation development, manufacturing, and commercialization. Its portfoli...
Tenatra connects Indian manufacturers with global buyers through active partners in Germany, Switzerland, Belgium, Spain & Turkey.
About the Company : Tenatra International was established as a proprietorship firm in 1999. It got off to a very good start, supporting clients in the United States, Mexico and Europe. As business opp...
Zeon Pharma is a manufacturer and supplier of APIs & Intermediates.
About the Company : Zeon Pharma Industries India Pvt. Ltd. is an ISO 9001:2015, cGMP, and WHO-GMP certified company with a dedicated manufacturing facility for Bulk Drugs (APIs), phytochemicals, herba...
Harika Drugs has been providing a qualitative range of Bulk Drugs/ APIs since 1993.
About the Company : Our endeavours also lie in the import, and domestic sourcing of raw materials from reliable vendors of the market. We have an excellent infrastructure with world class cGMP facilit...
Willow Birch Pharma delivers trusted, high-quality APIs nationwide with unmatched service, compliance, and competitive value.
About the Company : Willow Birch Pharma, Inc. is a premier supplier of bulk APIs to North American Compounding Pharmacies, sourcing from FDA registered and GMP manufacturers. With licenses in all 50 s...
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DOSAGE - TABLET;ORAL - EQ 100MG BASE
USFDA APPLICATION NUMBER - 19839
DOSAGE - TABLET;ORAL - EQ 150MG BASE **Federa...DOSAGE - TABLET;ORAL - EQ 150MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 19839
DOSAGE - TABLET;ORAL - EQ 200MG BASE **Federa...DOSAGE - TABLET;ORAL - EQ 200MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 19839
DOSAGE - TABLET;ORAL - EQ 25MG BASE
USFDA APPLICATION NUMBER - 19839
DOSAGE - TABLET;ORAL - EQ 50MG BASE
USFDA APPLICATION NUMBER - 19839
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ABOUT THIS PAGE
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PharmaCompass offers a list of Sertraline Hydrochloride API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Sertraline Hydrochloride manufacturer or Sertraline Hydrochloride supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Sertraline Hydrochloride manufacturer or Sertraline Hydrochloride supplier.
A SERTRALINE HCL (2) manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of SERTRALINE HCL (2), including repackagers and relabelers. The FDA regulates SERTRALINE HCL (2) manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. SERTRALINE HCL (2) 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 SERTRALINE HCL (2) manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A SERTRALINE HCL (2) supplier is an individual or a company that provides SERTRALINE HCL (2) active pharmaceutical ingredient (API) or SERTRALINE HCL (2) finished formulations upon request. The SERTRALINE HCL (2) suppliers may include SERTRALINE HCL (2) API manufacturers, exporters, distributors and traders.
click here to find a list of SERTRALINE HCL (2) suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A SERTRALINE HCL (2) DMF (Drug Master File) is a document detailing the whole manufacturing process of SERTRALINE HCL (2) active pharmaceutical ingredient (API) in detail. Different forms of SERTRALINE HCL (2) DMFs exist exist since differing nations have different regulations, such as SERTRALINE HCL (2) USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A SERTRALINE HCL (2) DMF submitted to regulatory agencies in the US is known as a USDMF. SERTRALINE HCL (2) USDMF includes data on SERTRALINE HCL (2)'s chemical properties, information on the facilities and procedures used, and details about packaging and storage. The SERTRALINE HCL (2) USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of SERTRALINE HCL (2) 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 SERTRALINE HCL (2) Drug Master File in Japan (SERTRALINE HCL (2) JDMF) empowers SERTRALINE HCL (2) 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 SERTRALINE HCL (2) JDMF during the approval evaluation for pharmaceutical products. At the time of SERTRALINE HCL (2) 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 SERTRALINE HCL (2) 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 SERTRALINE HCL (2) Drug Master File in Korea (SERTRALINE HCL (2) KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of SERTRALINE HCL (2). The MFDS reviews the SERTRALINE HCL (2) KDMF as part of the drug registration process and uses the information provided in the SERTRALINE HCL (2) KDMF to evaluate the safety and efficacy of the drug.
After submitting a SERTRALINE HCL (2) 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 SERTRALINE HCL (2) API can apply through the Korea Drug Master File (KDMF).
click here to find a list of SERTRALINE HCL (2) suppliers with KDMF on PharmaCompass.
A SERTRALINE HCL (2) CEP of the European Pharmacopoeia monograph is often referred to as a SERTRALINE HCL (2) Certificate of Suitability (COS). The purpose of a SERTRALINE HCL (2) CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of SERTRALINE HCL (2) EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of SERTRALINE HCL (2) to their clients by showing that a SERTRALINE HCL (2) CEP has been issued for it. The manufacturer submits a SERTRALINE HCL (2) CEP (COS) as part of the market authorization procedure, and it takes on the role of a SERTRALINE HCL (2) CEP holder for the record. Additionally, the data presented in the SERTRALINE HCL (2) CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the SERTRALINE HCL (2) DMF.
A SERTRALINE HCL (2) CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. SERTRALINE HCL (2) 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 SERTRALINE HCL (2) suppliers with CEP (COS) on PharmaCompass.
A SERTRALINE HCL (2) written confirmation (SERTRALINE HCL (2) WC) is an official document issued by a regulatory agency to a SERTRALINE HCL (2) manufacturer, verifying that the manufacturing facility of a SERTRALINE HCL (2) active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting SERTRALINE HCL (2) APIs or SERTRALINE HCL (2) finished pharmaceutical products to another nation, regulatory agencies frequently require a SERTRALINE HCL (2) WC (written confirmation) as part of the regulatory process.
click here to find a list of SERTRALINE HCL (2) 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 SERTRALINE HCL (2) as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for SERTRALINE HCL (2) 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 SERTRALINE HCL (2) 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 SERTRALINE HCL (2) and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a SERTRALINE HCL (2) NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of SERTRALINE HCL (2) suppliers with NDC on PharmaCompass.
SERTRALINE HCL (2) 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 SERTRALINE HCL (2) GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right SERTRALINE HCL (2) GMP manufacturer or SERTRALINE HCL (2) GMP API supplier for your needs.
A SERTRALINE HCL (2) CoA (Certificate of Analysis) is a formal document that attests to SERTRALINE HCL (2)'s compliance with SERTRALINE HCL (2) specifications and serves as a tool for batch-level quality control.
SERTRALINE HCL (2) CoA mostly includes findings from lab analyses of a specific batch. For each SERTRALINE HCL (2) 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.
SERTRALINE HCL (2) may be tested according to a variety of international standards, such as European Pharmacopoeia (SERTRALINE HCL (2) EP), SERTRALINE HCL (2) JP (Japanese Pharmacopeia) and the US Pharmacopoeia (SERTRALINE HCL (2) USP).
