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DRUG PRODUCT COMPOSITIONS0
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API SUPPLIERS
HRV Pharma - Market Expansion Leader in Pharmaceuticals.
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
Evonik Health Care is the innovation hub for leading life science companies
Metrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
✕ Product Not Available For Sales
Expand your portfolio with Egis- value-added generics, API capabilities, and reliable contract services to drive your growth.
Jai Radhe Sales is your partner for all your sourcing needs.
Moehs Group, a reference company in the production of pharmaceutical active ingredients.
Tagoor's product development expertise, backed by our comprehensive understanding of the processes, helps us offer high-quality APIs.
Tenatra connects Indian manufacturers with global buyers through active partners in Germany, Switzerland, Belgium, Spain & Turkey.
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USDMF
Moehs Group, a reference company in the production of pharmaceutical active ingredients.
GDUFA
DMF Review : Complete
Rev. Date : 2022-04-15
Pay. Date : 2022-03-08
DMF Number : 36834
Submission : 2022-03-16
Status :
Type : II
SCI Pharmtech offers high-quality, cost-effective APIs, advanced intermediates, & custom products with global expertise and precision.
GDUFA
DMF Review : Complete
Rev. Date : 2013-07-23
Pay. Date : 2013-03-06
DMF Number : 24939
Submission : 2011-05-06
Status :
Type : II
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Expand your portfolio with Egis- value-added generics, API capabilities, and reliable contract services to drive your growth.
Certificate Number : CEP 2023-144 - Rev 00
Status : Valid
Issue Date : 2024-12-19
Type : Chemical
Substance Number : 2594
Moehs Group, a reference company in the production of pharmaceutical active ingredients.
Duloxetine Hydrochloride, Milled, Micronised
Certificate Number : CEP 2012-319 - Rev 01
Status : Valid
Issue Date : 2024-06-21
Type : Chemical
Substance Number : 2594
SCI Pharmtech offers high-quality, cost-effective APIs, advanced intermediates, & custom products with global expertise and precision.
Certificate Number : R1-CEP 2012-217 - Rev 01
Status : Valid
Issue Date : 2022-09-21
Type : Chemical
Substance Number : 2594
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FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Drugs in Development
Lead Product(s) : Duloxetine Hydrochloride,Inapplicable
Therapeutic Area : Undisclosed
Highest Development Status : Phase I
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Bioavailability Study of Duloxetine Delayed-Relase Capsules 60 mg Under Fed Condition
Details : Duloxetine is a Other Small Molecule drug candidate, which is currently being evaluated in phase I clinical studies for the treatment of undefined medical condition.
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Inapplicable
November 14, 2014
Lead Product(s) : Duloxetine Hydrochloride,Inapplicable
Therapeutic Area : Undisclosed
Highest Development Status : Phase I
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Bioavailability Study of Duloxetine Delayed-Release Capsules 60 mg Under Fasting Condition
Details : Duloxetine is a Other Small Molecule drug candidate, which is currently being evaluated in phase I clinical studies for the treatment of undefined medical condition.
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Inapplicable
November 14, 2014
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]INTERMEDIATE SUPPLIERS
Aarti Pharmalabs is a partner of choice for pharmaceutical companies for APIs & Intermediates. Largest Indian producer of Caffeine.
(S)-3-Methyl amino-1-(2-thienyl)-1-propanol
CAS Number : 116539-55-0
End Use API : Duloxetine Hydrochloride
About The Company : Aarti Pharmalabs is generic APIs & Intermediates manufacturing company & small molecule drug substance CDMO and the largest Indian manufacturer of Xanthine Deri...
Tagoor's product development expertise, backed by our comprehensive understanding of the processes, helps us offer high-quality APIs.
(S)-N-Methyl-3-hydroxy-3-(2-thienyl)propanamine
CAS Number : 116539-55-0
End Use API : Duloxetine Hydrochloride
About The Company : Tagoor Laboratories, established in 2018 and part of the Tagoor Group, provides APIs, advanced intermediates, and key starting materials for critical and high-g...
Zeon Pharma is a manufacturer and supplier of APIs & Intermediates.
RS-N,N-Dimethyl-3-hydroxy-3-(2-thienyl)-1-propanam...
CAS Number : 13636-02-7
End Use API : Duloxetine Hydrochloride
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), p...
Zeon Pharma is a manufacturer and supplier of APIs & Intermediates.
S-(+)-N,N- Dimethyl-3-(1-Naphthalenyloxy)-3-(2-thi...
CAS Number : 132335-44-5
End Use API : Duloxetine Hydrochloride
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), p...
Zeon Pharma is a manufacturer and supplier of APIs & Intermediates.
RS-N,N- Dimethyl-3-(1-Naphthalenyloxy)-3-(2-thieny...
CAS Number : 116817-84-6
End Use API : Duloxetine Hydrochloride
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), p...
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DOSAGE - CAPSULE, DELAYED REL PELLETS;ORAL - ...DOSAGE - CAPSULE, DELAYED REL PELLETS;ORAL - EQ 20MG BASE
USFDA APPLICATION NUMBER - 21427
DOSAGE - CAPSULE, DELAYED REL PELLETS;ORAL - ...DOSAGE - CAPSULE, DELAYED REL PELLETS;ORAL - EQ 30MG BASE
USFDA APPLICATION NUMBER - 21427
DOSAGE - CAPSULE, DELAYED REL PELLETS;ORAL - ...DOSAGE - CAPSULE, DELAYED REL PELLETS;ORAL - EQ 60MG BASE
USFDA APPLICATION NUMBER - 21427
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Evonik
Evonik Health Care is the innovation hub for leading life science companies
Dosage Form : Capsule
Grade : Oral
Brand Name : EUDRAGIT® L 100-55
Application : Controlled & Modified Release
Excipient Details : EUDRAGIT® L 100-55 (powder) is used in delayed release coatings to enhance solubility of poorly soluble drugs such as tablets, capsules & granules.
Pharmacopoeia Ref : NA
Technical Specs : NA
Ingredient(s) : Methacrylic Acid - Ethyl Acrylate Copolymer
Evonik Health Care is the innovation hub for leading life science companies
Dosage Form : Tablet
Grade : Oral
Brand Name : EUDRAGIT® L 30 D-55
Application : Film Formers & Plasticizers
Excipient Details : EUDRAGIT® L 30 D-55 (aqueous dispersion) is a delayed release polymer used as coating and film former in tablets, capsules, granules etc.
Pharmacopoeia Ref : NA
Technical Specs : NA
Ingredient(s) : Methacrylic Acid - Ethyl Acrylate Copolymer
Evonik Health Care is the innovation hub for leading life science companies
Dosage Form : Orodispersible Tablet
Grade : Oral, Topical
Application : Disintegrants & Superdisintegrants
Excipient Details : Glycine is used as a disintegrant in solid dosage forms such as orally disintegrating tablets and in topical formulations such as emulsions & creams.
Pharmacopoeia Ref : NA
Technical Specs : Molecular weight: 75.07 g/mol
Ingredient(s) : Glycine Excipient
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Rochem International Inc
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FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Coating Systems & Additives
Evonik Health Care is the innovation hub for leading life science companies
Brand Name : EUDRAGIT® L 30 D-55
Application : Coating Systems & Additives, Film Formers & Plasticizers
Excipient Details : EUDRAGIT® L 30 D-55 (aqueous dispersion) is a delayed release polymer used as coating and film former in tablets, capsules, granules etc.
Pharmacopoeia Ref : NA
Technical Specs : NA
Ingredient(s) : Methacrylic Acid - Ethyl Acrylate Copolymer
Evonik Health Care is the innovation hub for leading life science companies
Dosage Form : Capsule, Granule / Pellet, Tablet
Grade : Oral
Brand Name : EUDRAGIT® L 100-55
Application : Coating Systems & Additives, Controlled & Modified Release, Solubilizers
Excipient Details : EUDRAGIT® L 100-55 (powder) is used in delayed release coatings to enhance solubility of poorly soluble drugs such as tablets, capsules & granules.
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Technical Specs : NA
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REF. STANDARDS & IMPURITIES
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ANALYTICAL
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ABOUT THIS PAGE
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PharmaCompass offers a list of Duloxetine 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 Duloxetine Hydrochloride manufacturer or Duloxetine Hydrochloride supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Duloxetine Hydrochloride manufacturer or Duloxetine Hydrochloride supplier.
A Duloxetine Hydrochloride manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Duloxetine Hydrochloride, including repackagers and relabelers. The FDA regulates Duloxetine Hydrochloride manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Duloxetine Hydrochloride 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 Duloxetine Hydrochloride manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Duloxetine Hydrochloride supplier is an individual or a company that provides Duloxetine Hydrochloride active pharmaceutical ingredient (API) or Duloxetine Hydrochloride finished formulations upon request. The Duloxetine Hydrochloride suppliers may include Duloxetine Hydrochloride API manufacturers, exporters, distributors and traders.
click here to find a list of Duloxetine Hydrochloride suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Duloxetine Hydrochloride DMF (Drug Master File) is a document detailing the whole manufacturing process of Duloxetine Hydrochloride active pharmaceutical ingredient (API) in detail. Different forms of Duloxetine Hydrochloride DMFs exist exist since differing nations have different regulations, such as Duloxetine Hydrochloride USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Duloxetine Hydrochloride DMF submitted to regulatory agencies in the US is known as a USDMF. Duloxetine Hydrochloride USDMF includes data on Duloxetine Hydrochloride's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Duloxetine Hydrochloride USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Duloxetine Hydrochloride 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 Duloxetine Hydrochloride Drug Master File in Japan (Duloxetine Hydrochloride JDMF) empowers Duloxetine Hydrochloride 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 Duloxetine Hydrochloride JDMF during the approval evaluation for pharmaceutical products. At the time of Duloxetine Hydrochloride 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 Duloxetine Hydrochloride 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 Duloxetine Hydrochloride Drug Master File in Korea (Duloxetine Hydrochloride KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Duloxetine Hydrochloride. The MFDS reviews the Duloxetine Hydrochloride KDMF as part of the drug registration process and uses the information provided in the Duloxetine Hydrochloride KDMF to evaluate the safety and efficacy of the drug.
After submitting a Duloxetine Hydrochloride 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 Duloxetine Hydrochloride API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Duloxetine Hydrochloride suppliers with KDMF on PharmaCompass.
A Duloxetine Hydrochloride CEP of the European Pharmacopoeia monograph is often referred to as a Duloxetine Hydrochloride Certificate of Suitability (COS). The purpose of a Duloxetine Hydrochloride CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Duloxetine Hydrochloride EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Duloxetine Hydrochloride to their clients by showing that a Duloxetine Hydrochloride CEP has been issued for it. The manufacturer submits a Duloxetine Hydrochloride CEP (COS) as part of the market authorization procedure, and it takes on the role of a Duloxetine Hydrochloride CEP holder for the record. Additionally, the data presented in the Duloxetine Hydrochloride CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Duloxetine Hydrochloride DMF.
A Duloxetine Hydrochloride CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Duloxetine Hydrochloride 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 Duloxetine Hydrochloride suppliers with CEP (COS) on PharmaCompass.
A Duloxetine Hydrochloride written confirmation (Duloxetine Hydrochloride WC) is an official document issued by a regulatory agency to a Duloxetine Hydrochloride manufacturer, verifying that the manufacturing facility of a Duloxetine Hydrochloride active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Duloxetine Hydrochloride APIs or Duloxetine Hydrochloride finished pharmaceutical products to another nation, regulatory agencies frequently require a Duloxetine Hydrochloride WC (written confirmation) as part of the regulatory process.
click here to find a list of Duloxetine Hydrochloride 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 Duloxetine Hydrochloride as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Duloxetine Hydrochloride 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 Duloxetine Hydrochloride 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 Duloxetine Hydrochloride and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Duloxetine Hydrochloride NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Duloxetine Hydrochloride suppliers with NDC on PharmaCompass.
Duloxetine Hydrochloride 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 Duloxetine Hydrochloride GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Duloxetine Hydrochloride GMP manufacturer or Duloxetine Hydrochloride GMP API supplier for your needs.
A Duloxetine Hydrochloride CoA (Certificate of Analysis) is a formal document that attests to Duloxetine Hydrochloride's compliance with Duloxetine Hydrochloride specifications and serves as a tool for batch-level quality control.
Duloxetine Hydrochloride CoA mostly includes findings from lab analyses of a specific batch. For each Duloxetine Hydrochloride 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.
Duloxetine Hydrochloride may be tested according to a variety of international standards, such as European Pharmacopoeia (Duloxetine Hydrochloride EP), Duloxetine Hydrochloride JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Duloxetine Hydrochloride USP).
