Synopsis
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CEP/COS
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VMF
DRUG PRODUCT COMPOSITIONS0
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API SUPPLIERS
Delivering Quality APIs, Drug Intermediates, and Specialty Chemicals to Over 50 Countries Across the Globe.
Olpha, a JSC AB City subsidiary, is a leading Baltic firm with 50 years of experience in medicines & chemical pharmaceuticals.
JDMF 
NDC
KDMF
ASMF
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
Cohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.
EU-WC
NDC
KDMF
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
CA
Jai Radhe Sales is your partner for all your sourcing needs.
HRV Global Life Sciences - Market Expansion Leader in Pharmaceuticals.
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
CA, ASMF
Excellence in API manufacturing with precision, innovation, and quality-trusted solutions for the global pharmaceutical industry.
Olpha, a JSC AB City subsidiary, is a leading Baltic firm with 50 years of experience in medicines & chemical pharmaceuticals.
ASMF
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USDMF
Olpha, a JSC AB City subsidiary, is a leading Baltic firm with 50 years of experience in medicines & chemical pharmaceuticals.
GDUFA
DMF Review : Complete
Rev. Date : 2013-02-07
Pay. Date : 2012-11-27
DMF Number : 20543
Submission : 2007-05-09
Status :
Type : II
Cohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.
GDUFA
DMF Review : Complete
Rev. Date : 2019-04-22
Pay. Date : 2019-02-11
DMF Number : 29180
Submission : 2015-03-16
Status :
Type : II
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
GDUFA
DMF Review : Complete
Rev. Date : 2015-11-13
Pay. Date : 2015-11-05
DMF Number : 20841
Submission : 2007-09-07
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 : 2012-11-23
Pay. Date : 2012-11-09
DMF Number : 20868
Submission : 2007-09-20
Status :
Type : II
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Delivering Quality APIs, Drug Intermediates, and Specialty Chemicals to Over 50 Countries Across the Globe.
About the Company : Zeal MediPharma is a globally recognized Star One Export House, serving customers in over 50 countries for more than two decades. We specialize in sourcing and exporting high-quali...
Olpha, a JSC AB City subsidiary, is a leading Baltic firm with 50 years of experience in medicines & chemical pharmaceuticals.
About the Company : Olpha, the subsidiary of JSC AB City, is one of the largest companies in the Baltic states with 50 years of experience in the production of medicines & chemical pharmaceutical prod...
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
About the Company : LGM Pharma is a global leader in sourcing hard-to-find APIs and intermediates for the pharmaceutical and biotech industries. LGM is also a full service CDMO providing formulation, ...
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, offering products and services across all phases of a molecule’s lifecycle from development to commercialzation. With our...
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
About the Company : Founded in 1984, DRL is well-known for its generic APIs and its track record in drug product development. It is one of the earliest pharma API manufacturers with a diverse portfoli...
Jai Radhe Sales is your partner for all your sourcing needs.
About the Company : Jai Radhe Sales was founded in 1999 as an out-of-the-box distribution firm specializing in the global supply of high-quality pharmaceutical ingredients. The firm provides complete ...
HRV Global Life Sciences - Market Expansion Leader in Pharmaceuticals.
About the Company : HRV Global is a leading global manufacturer, seller & exporter of a wide range of APIs, advanced intermediates, pellets, food grade chemicals, food additives & food ingredients. It...
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-standing tradition of advancing health through innovation and dedication. Today, we proudly build upon this legacy, drivi...
Excellence in API manufacturing with precision, innovation, and quality-trusted solutions for the global pharmaceutical industry.
About the Company : JPN Pharma is a premier pharmaceutical company in India, specializing in the development and manufacturing of Active Pharmaceutical Ingredients (APIs) and drug intermediates. Headq...
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API Imports and Exports
Drugs in Development
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FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Canada
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DOSAGE - TABLET;ORAL - 10MG
USFDA APPLICATION NUMBER - 21487
DOSAGE - TABLET;ORAL - 5MG
USFDA APPLICATION NUMBER - 21487
DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 14M...DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 14MG
USFDA APPLICATION NUMBER - 22525
DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 21M...DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 21MG
USFDA APPLICATION NUMBER - 22525
DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 28M...DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 28MG
USFDA APPLICATION NUMBER - 22525
DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 7MG...DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 7MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 22525
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Controlled & Modified Release
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Granulation
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Topical
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API Stability Enhancers
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Soft Gelatin
Digital Content
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Global Sales Information
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USP
ANALYTICAL
ABOUT THIS PAGE
24
PharmaCompass offers a list of Memantine 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 Memantine Hydrochloride manufacturer or Memantine Hydrochloride supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Memantine Hydrochloride manufacturer or Memantine Hydrochloride supplier.
PharmaCompass also assists you with knowing the Memantine Hydrochloride API Price utilized in the formulation of products. Memantine Hydrochloride API Price is not always fixed or binding as the Memantine Hydrochloride Price is obtained through a variety of data sources. The Memantine Hydrochloride Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Memantine HCl manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Memantine HCl, including repackagers and relabelers. The FDA regulates Memantine HCl manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Memantine HCl 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 Memantine HCl manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Memantine HCl supplier is an individual or a company that provides Memantine HCl active pharmaceutical ingredient (API) or Memantine HCl finished formulations upon request. The Memantine HCl suppliers may include Memantine HCl API manufacturers, exporters, distributors and traders.
click here to find a list of Memantine HCl suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Memantine HCl DMF (Drug Master File) is a document detailing the whole manufacturing process of Memantine HCl active pharmaceutical ingredient (API) in detail. Different forms of Memantine HCl DMFs exist exist since differing nations have different regulations, such as Memantine HCl USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Memantine HCl DMF submitted to regulatory agencies in the US is known as a USDMF. Memantine HCl USDMF includes data on Memantine HCl's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Memantine HCl USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Memantine HCl 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 Memantine HCl Drug Master File in Japan (Memantine HCl JDMF) empowers Memantine HCl 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 Memantine HCl JDMF during the approval evaluation for pharmaceutical products. At the time of Memantine HCl 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 Memantine HCl 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 Memantine HCl Drug Master File in Korea (Memantine HCl KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Memantine HCl. The MFDS reviews the Memantine HCl KDMF as part of the drug registration process and uses the information provided in the Memantine HCl KDMF to evaluate the safety and efficacy of the drug.
After submitting a Memantine HCl 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 Memantine HCl API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Memantine HCl suppliers with KDMF on PharmaCompass.
A Memantine HCl written confirmation (Memantine HCl WC) is an official document issued by a regulatory agency to a Memantine HCl manufacturer, verifying that the manufacturing facility of a Memantine HCl active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Memantine HCl APIs or Memantine HCl finished pharmaceutical products to another nation, regulatory agencies frequently require a Memantine HCl WC (written confirmation) as part of the regulatory process.
click here to find a list of Memantine HCl 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 Memantine HCl as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Memantine HCl 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 Memantine HCl 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 Memantine HCl and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Memantine HCl NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Memantine HCl suppliers with NDC on PharmaCompass.
Memantine HCl 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 Memantine HCl 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 Memantine HCl GMP manufacturer or Memantine HCl GMP API supplier for your needs.
A Memantine HCl CoA (Certificate of Analysis) is a formal document that attests to Memantine HCl's compliance with Memantine HCl specifications and serves as a tool for batch-level quality control.
Memantine HCl CoA mostly includes findings from lab analyses of a specific batch. For each Memantine HCl 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.
Memantine HCl may be tested according to a variety of international standards, such as European Pharmacopoeia (Memantine HCl EP), Memantine HCl JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Memantine HCl USP).
