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Australia
DRUG PRODUCT COMPOSITIONS0
Data Compilation #PharmaFlow
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API SUPPLIERS
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USDMF
Cohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.
GDUFA
DMF Review : Complete
Rev. Date : 2022-11-03
Pay. Date : 2022-10-12
DMF Number : 34507
Submission : 2020-01-11
Status :
Type : II
Moehs Group, a reference company in the production of pharmaceutical active ingredients.
GDUFA
DMF Review : Complete
Rev. Date : 2013-04-10
Pay. Date : 2013-04-02
DMF Number : 17258
Submission : 2004-03-01
Status :
Type : II
Aarti Pharmalabs is a partner of choice for pharmaceutical companies for APIs & Intermediates. Largest Indian producer of Caffeine.
GDUFA
DMF Review : Complete
Rev. Date : 2017-05-26
Pay. Date : 2015-07-13
DMF Number : 28433
Submission : 2014-07-28
Status :
Type : II
Aarti Pharmalabs is a partner of choice for pharmaceutical companies for APIs & Intermediates. Largest Indian producer of Caffeine.
GDUFA
DMF Review : Complete
Rev. Date : 2016-02-12
Pay. Date : 2016-01-28
DMF Number : 19879
Submission : 2006-10-11
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 : 2012-12-24
Pay. Date : 2012-11-13
DMF Number : 16281
Submission : 2002-12-02
Status :
Type : II
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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 ...
Cohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.
About the Company : Cohance Lifesciences is a leading CDMO and API platform delivering products and services across the full molecule lifecycle, from development to commercialization. With strong expe...
Gonane has API manufacturing expertise in new-age Corticosteroids, Hormones and other pharma raw materials.
About the Company : Gonane Pharma is a contract pharmaceutical company based in Gujarat, India, specializing in the manufacturing and marketing of corticosteroids, hormones, antivirals, and oncology p...
Moehs Group, a reference company in the production of pharmaceutical active ingredients.
About the Company : Since 1962, MOEHS has produced high-quality Active Pharmaceutical Ingredients (APIs) for the global market. With decades of technical expertise, Moehs Group delivers pharmaceutical...
Aarti Pharmalabs is a partner of choice for pharmaceutical companies for APIs & Intermediates. Largest Indian producer of Caffeine.
About the Company : Aarti Pharmalabs is generic APIs & Intermediates manufacturing company & small molecule drug substance CDMO and the largest Indian manufacturer of Xanthine Derivatives (Caffeine, e...
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...
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...
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
About the Company : Founded in 1935, TAPI Technology & API Services has a long legacy of advancing health through innovation. Today, we offer one of the industry’s most comprehensive API portfolios ...
Lupin Manufacturing Solutions – delivering high-quality APIs & end-to-end CDMO services for faster, cost-effective drug development.
About the Company : Lupin Manufacturing Solutions (LMS), a wholly owned Lupin subsidiary, offers high-quality APIs and end-to-end CDMO services from R&D to commercial scale. Backed by five decades of ...
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DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - EQ ...DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - EQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 20699
DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - EQ ...DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - EQ 150MG BASE
USFDA APPLICATION NUMBER - 20699
DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - EQ ...DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - EQ 37.5MG BASE
USFDA APPLICATION NUMBER - 20699
DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - EQ ...DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - EQ 75MG BASE
USFDA APPLICATION NUMBER - 20699
DOSAGE - TABLET, EXTENDED RELEASE;ORAL - EQ 1...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - EQ 150MG BASE
USFDA APPLICATION NUMBER - 22104
DOSAGE - TABLET, EXTENDED RELEASE;ORAL - EQ 2...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - EQ 225MG BASE
USFDA APPLICATION NUMBER - 22104
DOSAGE - TABLET, EXTENDED RELEASE;ORAL - EQ 3...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - EQ 37.5MG BASE
USFDA APPLICATION NUMBER - 22104
DOSAGE - TABLET, EXTENDED RELEASE;ORAL - EQ 7...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - EQ 75MG BASE
USFDA APPLICATION NUMBER - 22104
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REF. STANDARDS & IMPURITIES
USP
ANALYTICAL
ABOUT THIS PAGE
27
PharmaCompass offers a list of Venlafaxine 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 Venlafaxine Hydrochloride manufacturer or Venlafaxine Hydrochloride supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Venlafaxine Hydrochloride manufacturer or Venlafaxine Hydrochloride supplier.
A Wyeth brand of venlafaxine hydrochloride manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Wyeth brand of venlafaxine hydrochloride, including repackagers and relabelers. The FDA regulates Wyeth brand of venlafaxine hydrochloride manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Wyeth brand of venlafaxine 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 Wyeth brand of venlafaxine hydrochloride manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Wyeth brand of venlafaxine hydrochloride supplier is an individual or a company that provides Wyeth brand of venlafaxine hydrochloride active pharmaceutical ingredient (API) or Wyeth brand of venlafaxine hydrochloride finished formulations upon request. The Wyeth brand of venlafaxine hydrochloride suppliers may include Wyeth brand of venlafaxine hydrochloride API manufacturers, exporters, distributors and traders.
click here to find a list of Wyeth brand of venlafaxine hydrochloride suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Wyeth brand of venlafaxine hydrochloride DMF (Drug Master File) is a document detailing the whole manufacturing process of Wyeth brand of venlafaxine hydrochloride active pharmaceutical ingredient (API) in detail. Different forms of Wyeth brand of venlafaxine hydrochloride DMFs exist exist since differing nations have different regulations, such as Wyeth brand of venlafaxine hydrochloride USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Wyeth brand of venlafaxine hydrochloride DMF submitted to regulatory agencies in the US is known as a USDMF. Wyeth brand of venlafaxine hydrochloride USDMF includes data on Wyeth brand of venlafaxine hydrochloride's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Wyeth brand of venlafaxine hydrochloride USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Wyeth brand of venlafaxine 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 Wyeth brand of venlafaxine hydrochloride Drug Master File in Japan (Wyeth brand of venlafaxine hydrochloride JDMF) empowers Wyeth brand of venlafaxine 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 Wyeth brand of venlafaxine hydrochloride JDMF during the approval evaluation for pharmaceutical products. At the time of Wyeth brand of venlafaxine 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 Wyeth brand of venlafaxine 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 Wyeth brand of venlafaxine hydrochloride Drug Master File in Korea (Wyeth brand of venlafaxine hydrochloride KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Wyeth brand of venlafaxine hydrochloride. The MFDS reviews the Wyeth brand of venlafaxine hydrochloride KDMF as part of the drug registration process and uses the information provided in the Wyeth brand of venlafaxine hydrochloride KDMF to evaluate the safety and efficacy of the drug.
After submitting a Wyeth brand of venlafaxine 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 Wyeth brand of venlafaxine hydrochloride API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Wyeth brand of venlafaxine hydrochloride suppliers with KDMF on PharmaCompass.
A Wyeth brand of venlafaxine hydrochloride CEP of the European Pharmacopoeia monograph is often referred to as a Wyeth brand of venlafaxine hydrochloride Certificate of Suitability (COS). The purpose of a Wyeth brand of venlafaxine hydrochloride CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Wyeth brand of venlafaxine hydrochloride EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Wyeth brand of venlafaxine hydrochloride to their clients by showing that a Wyeth brand of venlafaxine hydrochloride CEP has been issued for it. The manufacturer submits a Wyeth brand of venlafaxine hydrochloride CEP (COS) as part of the market authorization procedure, and it takes on the role of a Wyeth brand of venlafaxine hydrochloride CEP holder for the record. Additionally, the data presented in the Wyeth brand of venlafaxine hydrochloride CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Wyeth brand of venlafaxine hydrochloride DMF.
A Wyeth brand of venlafaxine hydrochloride CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Wyeth brand of venlafaxine 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 Wyeth brand of venlafaxine hydrochloride suppliers with CEP (COS) on PharmaCompass.
A Wyeth brand of venlafaxine hydrochloride written confirmation (Wyeth brand of venlafaxine hydrochloride WC) is an official document issued by a regulatory agency to a Wyeth brand of venlafaxine hydrochloride manufacturer, verifying that the manufacturing facility of a Wyeth brand of venlafaxine hydrochloride active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Wyeth brand of venlafaxine hydrochloride APIs or Wyeth brand of venlafaxine hydrochloride finished pharmaceutical products to another nation, regulatory agencies frequently require a Wyeth brand of venlafaxine hydrochloride WC (written confirmation) as part of the regulatory process.
click here to find a list of Wyeth brand of venlafaxine 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 Wyeth brand of venlafaxine hydrochloride as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Wyeth brand of venlafaxine 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 Wyeth brand of venlafaxine 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 Wyeth brand of venlafaxine hydrochloride and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Wyeth brand of venlafaxine hydrochloride NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Wyeth brand of venlafaxine hydrochloride suppliers with NDC on PharmaCompass.
Wyeth brand of venlafaxine 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 Wyeth brand of venlafaxine 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 Wyeth brand of venlafaxine hydrochloride GMP manufacturer or Wyeth brand of venlafaxine hydrochloride GMP API supplier for your needs.
A Wyeth brand of venlafaxine hydrochloride CoA (Certificate of Analysis) is a formal document that attests to Wyeth brand of venlafaxine hydrochloride's compliance with Wyeth brand of venlafaxine hydrochloride specifications and serves as a tool for batch-level quality control.
Wyeth brand of venlafaxine hydrochloride CoA mostly includes findings from lab analyses of a specific batch. For each Wyeth brand of venlafaxine 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.
Wyeth brand of venlafaxine hydrochloride may be tested according to a variety of international standards, such as European Pharmacopoeia (Wyeth brand of venlafaxine hydrochloride EP), Wyeth brand of venlafaxine hydrochloride JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Wyeth brand of venlafaxine hydrochloride USP).
