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VMF
DRUG PRODUCT COMPOSITIONS0
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API SUPPLIERS
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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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Egis is a Hungarian generic pharma company with 110 years history. Our activities incorporate all areas of the pharma value chain.
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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Evonik Health Care is the innovation hub for leading life science companies
Registrant Name : Lilly Korea Ltd.
Registration Date : 2007-01-25
Registration Number : Su51-3-ND
Manufacturer Name : Evonik Corporation
Manufacturer Address : Tippecanoe Laboratories1650 Lilly Road Lafayette, IN 47909
Moehs Group, a reference company in the production of pharmaceutical active ingredients.
Registrant Name : Saehan Pharmaceutical Co., Ltd.
Registration Date : 2015-07-27
Registration Number : Su4098-3-ND
Manufacturer Name : Moehs Cantabra SL_x000D_
Manufacturer Address : Poligono Industrial Requejada, 39313, Polanco, Cantabria, Spain
SCI Pharmtech offers high-quality, cost-effective APIs, advanced intermediates, & custom products with global expertise and precision.
Registrant Name : Aging Life Science Co., Ltd.
Registration Date : 2013-09-05
Registration Number : Su4692-11-ND
Manufacturer Name : SCI Pharmtech, Inc.
Manufacturer Address : 186-2, Hai-Hu-Village, Lu-Chu-District, Taoyuan City 33856, Taiwan
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Drugs in Development
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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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Fillers, Diluents & Binders
Solubilizers
Disintegrants & Superdisintegrants
Controlled & Modified Release
Direct Compression
Granulation
Thickeners and Stabilizers
Topical
Taste Masking
Parenteral
Chewable & Orodispersible Aids
Lubricants & Glidants
Film Formers & Plasticizers
Co-Processed Excipients
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Empty Capsules
API Stability Enhancers
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Rheology Modifiers
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Coloring Agents
Digital Content
DATA COMPILATION #PharmaFlow
NEWS #PharmaBuzz
Global Sales Information
US Medicaid Prescriptions
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REF. STANDARDS & IMPURITIES
USP
ANALYTICAL
BioAnalytical Methods
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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 Cymbalta manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Cymbalta, including repackagers and relabelers. The FDA regulates Cymbalta manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Cymbalta 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 Cymbalta manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Cymbalta supplier is an individual or a company that provides Cymbalta active pharmaceutical ingredient (API) or Cymbalta finished formulations upon request. The Cymbalta suppliers may include Cymbalta API manufacturers, exporters, distributors and traders.
click here to find a list of Cymbalta suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Cymbalta DMF (Drug Master File) is a document detailing the whole manufacturing process of Cymbalta active pharmaceutical ingredient (API) in detail. Different forms of Cymbalta DMFs exist exist since differing nations have different regulations, such as Cymbalta USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Cymbalta DMF submitted to regulatory agencies in the US is known as a USDMF. Cymbalta USDMF includes data on Cymbalta's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Cymbalta USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Cymbalta 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 Cymbalta Drug Master File in Japan (Cymbalta JDMF) empowers Cymbalta 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 Cymbalta JDMF during the approval evaluation for pharmaceutical products. At the time of Cymbalta 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 Cymbalta 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 Cymbalta Drug Master File in Korea (Cymbalta KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Cymbalta. The MFDS reviews the Cymbalta KDMF as part of the drug registration process and uses the information provided in the Cymbalta KDMF to evaluate the safety and efficacy of the drug.
After submitting a Cymbalta 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 Cymbalta API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Cymbalta suppliers with KDMF on PharmaCompass.
A Cymbalta CEP of the European Pharmacopoeia monograph is often referred to as a Cymbalta Certificate of Suitability (COS). The purpose of a Cymbalta CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Cymbalta EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Cymbalta to their clients by showing that a Cymbalta CEP has been issued for it. The manufacturer submits a Cymbalta CEP (COS) as part of the market authorization procedure, and it takes on the role of a Cymbalta CEP holder for the record. Additionally, the data presented in the Cymbalta CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Cymbalta DMF.
A Cymbalta CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Cymbalta 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 Cymbalta suppliers with CEP (COS) on PharmaCompass.
A Cymbalta written confirmation (Cymbalta WC) is an official document issued by a regulatory agency to a Cymbalta manufacturer, verifying that the manufacturing facility of a Cymbalta active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Cymbalta APIs or Cymbalta finished pharmaceutical products to another nation, regulatory agencies frequently require a Cymbalta WC (written confirmation) as part of the regulatory process.
click here to find a list of Cymbalta 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 Cymbalta as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Cymbalta 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 Cymbalta 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 Cymbalta and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Cymbalta NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Cymbalta suppliers with NDC on PharmaCompass.
Cymbalta 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 Cymbalta GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Cymbalta GMP manufacturer or Cymbalta GMP API supplier for your needs.
A Cymbalta CoA (Certificate of Analysis) is a formal document that attests to Cymbalta's compliance with Cymbalta specifications and serves as a tool for batch-level quality control.
Cymbalta CoA mostly includes findings from lab analyses of a specific batch. For each Cymbalta 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.
Cymbalta may be tested according to a variety of international standards, such as European Pharmacopoeia (Cymbalta EP), Cymbalta JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Cymbalta USP).
