Synopsis
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VMF
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DRUG PRODUCT COMPOSITIONSUS Medicaid
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Annual Reports
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FDF
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Data Compilation #PharmaFlow
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Weekly News Recap #Phispers
API SUPPLIERS
Pharm-Rx is a reputed global importer and distributor of pharmaceutical active ingredients.
Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.
KDMF
ASMF, BR 
Jai Radhe Sales is your partner for all your sourcing needs.
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
TransoPharm USA works in the Sourcing and Management of Active Pharmaceutical Ingredients.
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
Transo-Pharm GmbH works globally to supply Active Pharmaceutical Ingredients adhering to the highest quality & GMP standards.
Rochem, your partner in developing, sourcing, and supplying pharmaceutical & animal health ingredients of Chinese origin.
HRV Pharma - Market Expansion Leader in Pharmaceuticals.
Tenatra connects Indian manufacturers with global buyers through active partners in Germany, Switzerland, Belgium, Spain & Turkey.
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USDMF
Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.
GDUFA
DMF Review : Complete
Rev. Date : 2014-03-19
Pay. Date : 2014-03-11
DMF Number : 14372
Submission : 1999-08-30
Status :
Type : II
Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 20998
Submission : 2007-10-31
Status :
Type : II
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 4989
Submission : 1983-06-28
Status :
Type : II
Synthokem Labs specializes in producing APIs and intermediates for the global pharma industry.
GDUFA
DMF Review : Complete
Rev. Date : 2014-04-08
Pay. Date : 2013-09-12
DMF Number : 10413
Submission : 1993-08-13
Status :
Type : II
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Pharm-Rx is a reputed global importer and distributor of pharmaceutical active ingredients.
About the Company : Established in 1991, Pharm-Rx is an importer and distributor of active ingredients serving the pharmaceutical, nutritional supplement, and food industries. The company follows a hi...
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 pharma company based in Hyderabad, committed to operational excellence, quality, and customer service. It manufactures across the ...
Jai Radhe Sales is your partner for all your sourcing needs.
About the Company : Jai Radhe Sales, founded in 1999, is a global distributor specializing in high-quality pharmaceutical ingredients from India. It offers complete sourcing solutions, technical and r...
TransoPharm USA works in the Sourcing and Management of Active Pharmaceutical Ingredients.
About the Company : Transo-Pharm is a licensed distributor of pharmaceutical components for human and veterinary markets. The company supports the full API life cycle, from development to sales, and a...
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
About the Company : LGM Pharma is a global leader in sourcing APIs, including hard-to-find drug substances, for pharmaceutical and biotech industries. LGM also operates as a full-service drug product ...
Transo-Pharm GmbH works globally to supply Active Pharmaceutical Ingredients adhering to the highest quality & GMP standards.
About the Company : Transo-Pharm, founded in 1987, is a fully licensed global distributor of pharmaceutical components for health and veterinary industries. It supports customers throughout the API li...
Rochem, your partner in developing, sourcing, and supplying pharmaceutical & animal health ingredients of Chinese origin.
About the Company : Rochem, established in 1994, is a global distributor of pharmaceutical, food, nutritional, and animal health ingredients, sourcing high-quality products from China. Headquartered i...
HRV Pharma - Market Expansion Leader in Pharmaceuticals.
About the Company : HRV Pharma is a global manufacturer, seller, and exporter of APIs, intermediates, pellets, food-grade chemicals, food additives, and food ingredients. The company provides sourcing...
Tenatra connects Indian manufacturers with global buyers through active partners in Germany, Switzerland, Belgium, Spain & Turkey.
About the Company : Tenatra International was established as a proprietorship firm in 1999. It got off to a very good start, supporting clients in the United States, Mexico and Europe. As business opp...
Synthokem Labs specializes in producing APIs and intermediates for the global pharma industry.
About the Company : Synthokem Labs Pvt Ltd is a privately owned company established in 1978, specializing in the production of Active Pharmaceutical Ingredients and Drug Intermediates. Operating acros...
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Drugs in Development
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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
83
PharmaCompass offers a list of Guaifenesin API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, 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.
A Anti-Tuss manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Anti-Tuss, including repackagers and relabelers. The FDA regulates Anti-Tuss manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Anti-Tuss 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 Anti-Tuss manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Anti-Tuss supplier is an individual or a company that provides Anti-Tuss active pharmaceutical ingredient (API) or Anti-Tuss finished formulations upon request. The Anti-Tuss suppliers may include Anti-Tuss API manufacturers, exporters, distributors and traders.
click here to find a list of Anti-Tuss suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Anti-Tuss DMF (Drug Master File) is a document detailing the whole manufacturing process of Anti-Tuss active pharmaceutical ingredient (API) in detail. Different forms of Anti-Tuss DMFs exist exist since differing nations have different regulations, such as Anti-Tuss USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Anti-Tuss DMF submitted to regulatory agencies in the US is known as a USDMF. Anti-Tuss USDMF includes data on Anti-Tuss's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Anti-Tuss USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Anti-Tuss 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 Anti-Tuss Drug Master File in Japan (Anti-Tuss JDMF) empowers Anti-Tuss 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 Anti-Tuss JDMF during the approval evaluation for pharmaceutical products. At the time of Anti-Tuss 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 Anti-Tuss 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 Anti-Tuss Drug Master File in Korea (Anti-Tuss KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Anti-Tuss. The MFDS reviews the Anti-Tuss KDMF as part of the drug registration process and uses the information provided in the Anti-Tuss KDMF to evaluate the safety and efficacy of the drug.
After submitting a Anti-Tuss 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 Anti-Tuss API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Anti-Tuss suppliers with KDMF on PharmaCompass.
A Anti-Tuss CEP of the European Pharmacopoeia monograph is often referred to as a Anti-Tuss Certificate of Suitability (COS). The purpose of a Anti-Tuss CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Anti-Tuss EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Anti-Tuss to their clients by showing that a Anti-Tuss CEP has been issued for it. The manufacturer submits a Anti-Tuss CEP (COS) as part of the market authorization procedure, and it takes on the role of a Anti-Tuss CEP holder for the record. Additionally, the data presented in the Anti-Tuss CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Anti-Tuss DMF.
A Anti-Tuss CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Anti-Tuss 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 Anti-Tuss suppliers with CEP (COS) on PharmaCompass.
A Anti-Tuss written confirmation (Anti-Tuss WC) is an official document issued by a regulatory agency to a Anti-Tuss manufacturer, verifying that the manufacturing facility of a Anti-Tuss active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Anti-Tuss APIs or Anti-Tuss finished pharmaceutical products to another nation, regulatory agencies frequently require a Anti-Tuss WC (written confirmation) as part of the regulatory process.
click here to find a list of Anti-Tuss 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 Anti-Tuss as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Anti-Tuss 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 Anti-Tuss 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 Anti-Tuss and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Anti-Tuss NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Anti-Tuss suppliers with NDC on PharmaCompass.
Anti-Tuss 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 Anti-Tuss GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Anti-Tuss GMP manufacturer or Anti-Tuss GMP API supplier for your needs.
A Anti-Tuss CoA (Certificate of Analysis) is a formal document that attests to Anti-Tuss's compliance with Anti-Tuss specifications and serves as a tool for batch-level quality control.
Anti-Tuss CoA mostly includes findings from lab analyses of a specific batch. For each Anti-Tuss 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.
Anti-Tuss may be tested according to a variety of international standards, such as European Pharmacopoeia (Anti-Tuss EP), Anti-Tuss JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Anti-Tuss USP).
