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Find Memantine Hydrochloride manufacturers, exporters & distributors on PharmaCompass

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  • TABLET;ORAL - 10MG
  • TABLET;ORAL - 5MG
  • CAPSULE, EXTENDED RELEASE;ORAL - 14MG
  • CAPSULE, EXTENDED RELEASE;ORAL - 21MG
  • CAPSULE, EXTENDED RELEASE;ORAL - 28MG
  • CAPSULE, EXTENDED RELEASE;ORAL - 7MG

Looking for 41100-52-1 / Memantine Hydrochloride API manufacturers, exporters & distributors?

Memantine Hydrochloride manufacturers, exporters & distributors 1

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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.

API | Excipient name

Memantine Hydrochloride

Synonyms

41100-52-1, Memantine hcl, Namenda, 3,5-dimethyl-1-adamantanamine hydrochloride, 3,5-dimethyladamantan-1-amine hydrochloride, Akatinol

Cas Number

41100-52-1

Unique Ingredient Identifier (UNII)

JY0WD0UA60

About Memantine Hydrochloride

AMANTADINE derivative that has some dopaminergic effects. It has been proposed as an antiparkinson agent.

Memantine Hydrochloride Manufacturers

A Memantine Hydrochloride manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Memantine Hydrochloride, including repackagers and relabelers. The FDA regulates Memantine Hydrochloride manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Memantine 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 Memantine Hydrochloride manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

Memantine Hydrochloride Suppliers

A Memantine Hydrochloride supplier is an individual or a company that provides Memantine Hydrochloride active pharmaceutical ingredient (API) or Memantine Hydrochloride finished formulations upon request. The Memantine Hydrochloride suppliers may include Memantine Hydrochloride API manufacturers, exporters, distributors and traders.

click here to find a list of Memantine Hydrochloride suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

Memantine Hydrochloride USDMF

A Memantine Hydrochloride DMF (Drug Master File) is a document detailing the whole manufacturing process of Memantine Hydrochloride active pharmaceutical ingredient (API) in detail. Different forms of Memantine Hydrochloride DMFs exist exist since differing nations have different regulations, such as Memantine Hydrochloride USDMF, ASMF (EDMF), JDMF, CDMF, etc.

A Memantine Hydrochloride DMF submitted to regulatory agencies in the US is known as a USDMF. Memantine Hydrochloride USDMF includes data on Memantine Hydrochloride's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Memantine Hydrochloride USDMF is kept confidential to protect the manufacturer’s intellectual property.

click here to find a list of Memantine Hydrochloride suppliers with USDMF on PharmaCompass.

Memantine Hydrochloride JDMF

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 Hydrochloride Drug Master File in Japan (Memantine Hydrochloride JDMF) empowers Memantine 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 Memantine Hydrochloride JDMF during the approval evaluation for pharmaceutical products. At the time of Memantine 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 Memantine Hydrochloride suppliers with JDMF on PharmaCompass.

Memantine Hydrochloride KDMF

In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.

Pharmaceutical companies submit a Memantine Hydrochloride Drug Master File in Korea (Memantine Hydrochloride KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Memantine Hydrochloride. The MFDS reviews the Memantine Hydrochloride KDMF as part of the drug registration process and uses the information provided in the Memantine Hydrochloride KDMF to evaluate the safety and efficacy of the drug.

After submitting a Memantine 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 Memantine Hydrochloride API can apply through the Korea Drug Master File (KDMF).

click here to find a list of Memantine Hydrochloride suppliers with KDMF on PharmaCompass.

Memantine Hydrochloride WC

A Memantine Hydrochloride written confirmation (Memantine Hydrochloride WC) is an official document issued by a regulatory agency to a Memantine Hydrochloride manufacturer, verifying that the manufacturing facility of a Memantine Hydrochloride active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Memantine Hydrochloride APIs or Memantine Hydrochloride finished pharmaceutical products to another nation, regulatory agencies frequently require a Memantine Hydrochloride WC (written confirmation) as part of the regulatory process.

click here to find a list of Memantine Hydrochloride suppliers with Written Confirmation (WC) on PharmaCompass.

Memantine Hydrochloride NDC

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 Hydrochloride as an active pharmaceutical ingredient (API).

Finished drug products

The FDA updates the NDC directory daily. The NDC numbers for Memantine Hydrochloride API and other APIs are published in this directory by the FDA.

Unfinished drugs

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 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.

Compounded drug products

The NDC directory also contains data on finished compounded human drug products that contain Memantine Hydrochloride and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Memantine Hydrochloride NDC to their finished compounded human drug products, they may choose to do so.

click here to find a list of Memantine Hydrochloride suppliers with NDC on PharmaCompass.

Memantine Hydrochloride GMP

Memantine 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 Memantine Hydrochloride 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 Hydrochloride GMP manufacturer or Memantine Hydrochloride GMP API supplier for your needs.

Memantine Hydrochloride CoA

A Memantine Hydrochloride CoA (Certificate of Analysis) is a formal document that attests to Memantine Hydrochloride's compliance with Memantine Hydrochloride specifications and serves as a tool for batch-level quality control.

Memantine Hydrochloride CoA mostly includes findings from lab analyses of a specific batch. For each Memantine 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.

Memantine Hydrochloride may be tested according to a variety of international standards, such as European Pharmacopoeia (Memantine Hydrochloride EP), Memantine Hydrochloride JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Memantine Hydrochloride USP).

Inform the supplier about your product requirements, specifying if you need a product with particular monograph like EP (Ph. Eur.), USP, JP, BP, or any other quality. In addition, clarify whether you need hydrochloride (HCl), anhydricum, base, micronisatum or a specific level of purity. To find reputable suppliers, utilize the filters and select those certified by GMP, FDA, or any other certification as per your requirement.
For your convenience, we have listed synonyms and CAS numbers to help you find the best supplier. The use of synonyms and CAS numbers can be helpful in identifying potential suppliers, but it is crucial to note that they might not always indicate the exact same product. It is important to confirm the product details with the supplier before making a purchase to ensure that it meets your requirements.
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