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API SUPPLIERS
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USDMF
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Atman Pharma Private Limited: A One Stop Solution Provider to All Your API Needs.
About the Company : Atman Pharma Private Limited is a fully integrated pharmaceutical company that has distinguished itself as a leader in Bulk Drugs (API) marketing both domestically in India and ove...
Pharm-Rx is a reputed global importer and distributor of pharmaceutical active ingredients.
About the Company : Pharm-Rx has earned an outstanding reputation since its establishment in 1991, serving as a reputable importer and distributor of active ingredients to the pharmaceutical, nutritio...
Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.
About the Company : Granules is a fast-growing, vertically integrated pharmaceutical company headquartered in Hyderabad, committed to operational excellence, quality, and customer service. It manufact...
TransoPharm USA works in the Sourcing and Management of Active Pharmaceutical Ingredients.
About the Company : Transo-Pharm, a fully licensed and certified distributor, specializes in pharmaceutical components for the health and veterinary industries. It offers support to clients throughout...
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, ...
Transo-Pharm GmbH works globally to supply Active Pharmaceutical Ingredients adhering to the highest quality & GMP standards.
About the Company : Founded in 1987, Transo-Pharm is a fully licensed and certified global distributor of pharmaceutical components for the health and veterinary industries. The company supports its c...
Rochem, your partner in developing, sourcing, and supplying pharmaceutical & animal health ingredients of Chinese origin.
About the Company : Established in 1994, Rochem is a distributor of pharmaceutical, food, nutritional and animal health ingredients to some of the largest companies in the world. It sources high-quali...
DKSH is your trusted partner for companies looking to grow their business in Asia & beyond.
About the Company : DKSH, founded with the goal of improving people's lives, assists businesses with market expansion and business growth in both existing and emerging markets. It has been fostering g...
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...
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DOSAGE - SOLUTION;ORAL - 200MG/5ML;2.5MG/5ML
USFDA APPLICATION NUMBER - 205474
DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 1.2G...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 1.2GM
USFDA APPLICATION NUMBER - 21282
DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 600M...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 600MG
USFDA APPLICATION NUMBER - 21282
DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 1.2G...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 1.2GM;120MG
USFDA APPLICATION NUMBER - 21585
DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 600M...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 600MG;60MG
USFDA APPLICATION NUMBER - 21585
DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 30MG...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 30MG;600MG
USFDA APPLICATION NUMBER - 21620
DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 60MG...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 60MG;1.2GM
USFDA APPLICATION NUMBER - 21620
DOSAGE - SOLUTION;ORAL - 200MG/5ML;2.5MG/5ML;...DOSAGE - SOLUTION;ORAL - 200MG/5ML;2.5MG/5ML;30MG/5ML
USFDA APPLICATION NUMBER - 22279
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ABOUT THIS PAGE
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PharmaCompass offers a list of Guaifenesin 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 Guaifenesin manufacturer or Guaifenesin supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Guaifenesin manufacturer or Guaifenesin supplier.
PharmaCompass also assists you with knowing the Guaifenesin API Price utilized in the formulation of products. Guaifenesin API Price is not always fixed or binding as the Guaifenesin Price is obtained through a variety of data sources. The Guaifenesin Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Mucinex manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Mucinex, including repackagers and relabelers. The FDA regulates Mucinex manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Mucinex 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 Mucinex manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Mucinex supplier is an individual or a company that provides Mucinex active pharmaceutical ingredient (API) or Mucinex finished formulations upon request. The Mucinex suppliers may include Mucinex API manufacturers, exporters, distributors and traders.
click here to find a list of Mucinex suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Mucinex DMF (Drug Master File) is a document detailing the whole manufacturing process of Mucinex active pharmaceutical ingredient (API) in detail. Different forms of Mucinex DMFs exist exist since differing nations have different regulations, such as Mucinex USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Mucinex DMF submitted to regulatory agencies in the US is known as a USDMF. Mucinex USDMF includes data on Mucinex's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Mucinex USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Mucinex 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 Mucinex Drug Master File in Japan (Mucinex JDMF) empowers Mucinex 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 Mucinex JDMF during the approval evaluation for pharmaceutical products. At the time of Mucinex 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 Mucinex 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 Mucinex Drug Master File in Korea (Mucinex KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Mucinex. The MFDS reviews the Mucinex KDMF as part of the drug registration process and uses the information provided in the Mucinex KDMF to evaluate the safety and efficacy of the drug.
After submitting a Mucinex 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 Mucinex API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Mucinex suppliers with KDMF on PharmaCompass.
A Mucinex CEP of the European Pharmacopoeia monograph is often referred to as a Mucinex Certificate of Suitability (COS). The purpose of a Mucinex CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Mucinex EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Mucinex to their clients by showing that a Mucinex CEP has been issued for it. The manufacturer submits a Mucinex CEP (COS) as part of the market authorization procedure, and it takes on the role of a Mucinex CEP holder for the record. Additionally, the data presented in the Mucinex CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Mucinex DMF.
A Mucinex CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Mucinex 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 Mucinex suppliers with CEP (COS) on PharmaCompass.
A Mucinex written confirmation (Mucinex WC) is an official document issued by a regulatory agency to a Mucinex manufacturer, verifying that the manufacturing facility of a Mucinex active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Mucinex APIs or Mucinex finished pharmaceutical products to another nation, regulatory agencies frequently require a Mucinex WC (written confirmation) as part of the regulatory process.
click here to find a list of Mucinex 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 Mucinex as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Mucinex 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 Mucinex 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 Mucinex and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Mucinex NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Mucinex suppliers with NDC on PharmaCompass.
Mucinex 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 Mucinex 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 Mucinex GMP manufacturer or Mucinex GMP API supplier for your needs.
A Mucinex CoA (Certificate of Analysis) is a formal document that attests to Mucinex's compliance with Mucinex specifications and serves as a tool for batch-level quality control.
Mucinex CoA mostly includes findings from lab analyses of a specific batch. For each Mucinex 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.
Mucinex may be tested according to a variety of international standards, such as European Pharmacopoeia (Mucinex EP), Mucinex JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Mucinex USP).
