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
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
NDC
Jai Radhe Sales is your partner for all your sourcing needs.
HRV Pharma - 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
JPN Pharma offers excellence in API manufacturing through precision, innovation & quality, delivering solutions to the pharma industry
NDC
ASMF
Olpha, a JSC AB City subsidiary, is a leading Baltic firm with 50 years of experience in medicines & chemical pharmaceuticals.
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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
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
GDUFA
DMF Review : Complete
Rev. Date : 2013-06-06
Pay. Date : 2013-05-22
DMF Number : 19549
Submission : 2006-06-20
Status :
Type : II
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]JDMF
Olpha, a JSC AB City subsidiary, is a leading Baltic firm with 50 years of experience in medicines & chemical pharmaceuticals.
Registration Number : 230MF10048
Registrant's Address : 5 Rupnicu Street, Olain, LV-2114, Latvia
Initial Date of Registration : 2018-03-30
Latest Date of Registration : 2018-03-30
Olpha, a JSC AB City subsidiary, is a leading Baltic firm with 50 years of experience in medicines & chemical pharmaceuticals.
Registration Number : 230MF10010
Registrant's Address : 5 Rupnicu Street, Olain, LV-2114, Latvia
Initial Date of Registration : 2018-01-24
Latest Date of Registration : 2018-01-24
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]EU WC
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]KDMF
Olpha, a JSC AB City subsidiary, is a leading Baltic firm with 50 years of experience in medicines & chemical pharmaceuticals.
Registrant Name : Eltek Pharmachem Co., Ltd.
Registration Date : 2020-05-22
Registration Number : 20200522-209-J-377
Manufacturer Name : JSC OlainFarm
Manufacturer Address : 5, Rupnicu Street, Olaine, LV-2114, Latvia
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]NDC API
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Listed Suppliers
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, ...
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 Pharma - Market Expansion Leader in Pharmaceuticals.
About the Company : HRV Pharma 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...
JPN Pharma offers excellence in API manufacturing through precision, innovation & quality, delivering solutions to the pharma 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...
About the Company : AMSA S.p.A, founded in 1953 near Italy’s iconic Lake Como, is the founding manufacturing company of the CFM Group. With a modernized facility and over six decades of experience, ...
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API/FDF Prices: Book a Demo to explore the features and consider upgrading later
API Imports and Exports
Drugs in Development
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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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ABOUT THIS PAGE
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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 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Memantine, including repackagers and relabelers. The FDA regulates Memantine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Memantine 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 manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Memantine supplier is an individual or a company that provides Memantine active pharmaceutical ingredient (API) or Memantine finished formulations upon request. The Memantine suppliers may include Memantine API manufacturers, exporters, distributors and traders.
click here to find a list of Memantine suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Memantine DMF (Drug Master File) is a document detailing the whole manufacturing process of Memantine active pharmaceutical ingredient (API) in detail. Different forms of Memantine DMFs exist exist since differing nations have different regulations, such as Memantine USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Memantine DMF submitted to regulatory agencies in the US is known as a USDMF. Memantine USDMF includes data on Memantine's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Memantine USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Memantine 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 Drug Master File in Japan (Memantine JDMF) empowers Memantine 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 JDMF during the approval evaluation for pharmaceutical products. At the time of Memantine 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 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 Drug Master File in Korea (Memantine KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Memantine. The MFDS reviews the Memantine KDMF as part of the drug registration process and uses the information provided in the Memantine KDMF to evaluate the safety and efficacy of the drug.
After submitting a Memantine 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 API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Memantine suppliers with KDMF on PharmaCompass.
A Memantine written confirmation (Memantine WC) is an official document issued by a regulatory agency to a Memantine manufacturer, verifying that the manufacturing facility of a Memantine active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Memantine APIs or Memantine finished pharmaceutical products to another nation, regulatory agencies frequently require a Memantine WC (written confirmation) as part of the regulatory process.
click here to find a list of Memantine 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 as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Memantine 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 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 and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Memantine NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Memantine suppliers with NDC on PharmaCompass.
Memantine 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 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 GMP manufacturer or Memantine GMP API supplier for your needs.
A Memantine CoA (Certificate of Analysis) is a formal document that attests to Memantine's compliance with Memantine specifications and serves as a tool for batch-level quality control.
Memantine CoA mostly includes findings from lab analyses of a specific batch. For each Memantine 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 may be tested according to a variety of international standards, such as European Pharmacopoeia (Memantine EP), Memantine JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Memantine USP).
