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  • TABLET;ORAL - 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
  • TABLET;ORAL - 750MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Looking for 532-03-6 / Methocarbamol API manufacturers, exporters & distributors?

Methocarbamol manufacturers, exporters & distributors 1

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PharmaCompass offers a list of Methocarbamol 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 Methocarbamol manufacturer or Methocarbamol supplier for your needs.

Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Methocarbamol manufacturer or Methocarbamol supplier.

PharmaCompass also assists you with knowing the Methocarbamol API Price utilized in the formulation of products. Methocarbamol API Price is not always fixed or binding as the Methocarbamol Price is obtained through a variety of data sources. The Methocarbamol Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.

API | Excipient name

Methocarbamol

Synonyms

532-03-6, Robaxin, Lumirelax, Metocarbamol, Parabaxin, Delaxin

Cas Number

532-03-6

Unique Ingredient Identifier (UNII)

125OD7737X

About Methocarbamol

A centrally acting muscle relaxant whose mode of action has not been established. It is used as an adjunct in the symptomatic treatment of musculoskeletal conditions associated with painful muscle spasm. (From Martindale, The Extra Pharmacopoeia, 30th ed, p1206)

Methocarbamol Manufacturers

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

Methocarbamol Suppliers

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

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

Methocarbamol USDMF

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

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

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

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

Methocarbamol KDMF

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

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

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

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

Methocarbamol WC

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

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

Methocarbamol 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 Methocarbamol as an active pharmaceutical ingredient (API).

Finished drug products

The FDA updates the NDC directory daily. The NDC numbers for Methocarbamol 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 Methocarbamol 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 Methocarbamol and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Methocarbamol NDC to their finished compounded human drug products, they may choose to do so.

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

Methocarbamol GMP

Methocarbamol 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 Methocarbamol 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 Methocarbamol GMP manufacturer or Methocarbamol GMP API supplier for your needs.

Methocarbamol CoA

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

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

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