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DRUG PRODUCT COMPOSITIONS0
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API SUPPLIERS
European CDMO and Gx manufacturer with 75 years of experience in delivering premium APIs to pharmaceutical partners worldwide.
Seqens is an integrated global leader in pharmaceutical solutions & specialty ingredients, & custom-made solutions to our customers.
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
Aspen API. More than just an API™
Cohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.
CEP/COS
EU-WC
KDMF
ASMF, RU
Jai Radhe Sales is your partner for all your sourcing needs.
HRV Pharma - Market Expansion Leader in Pharmaceuticals.
Octavius Pharma has been empowering lives since 1980 by providing quality products like DC granules, APIs and FDFs.
Delivering quality and niche Active Pharmaceutical Ingredients across the global from our USFDA-approved facility.
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USDMF
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European CDMO and Gx manufacturer with 75 years of experience in delivering premium APIs to pharmaceutical partners worldwide.
About the Company : Polpharma API, a division of a leading Polish pharmaceutical group, has over 75 years of expertise in process development and cGMP manufacturing. Based at an FDA-approved site in C...
Seqens is an integrated global leader in pharmaceutical solutions & specialty ingredients, & custom-made solutions to our customers.
About the Company : Founded in 2003, Seqens has evolved into a global leader in pharmaceutical solutions and specialty ingredients. The company supports customers in the development, scale-up, and man...
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 ...
Aspen API. More than just an API™
About the Company : Aspen API is a cooperative entity formed by Aspen Oss in the Netherlands and Fine Chemicals Corporation in South Africa. The company supplies a broad portfolio of over 50 high-qual...
Cohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.
About the Company : Cohance Lifesciences is a leading CDMO and API platform delivering products and services across the full molecule lifecycle, from development to commercialization. With strong expe...
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...
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...
Octavius Pharma has been empowering lives since 1980 by providing quality products like DC granules, APIs and FDFs.
About the Company : Octavius Pharma is a global leader in Directly Compressible Granules with over 45 years of experience in formulation development, manufacturing, and commercialization. Its portfoli...
Delivering quality and niche Active Pharmaceutical Ingredients across the global from our USFDA-approved facility.
About the Company : Mankind Pharma was established in 1986 and began operating as a fully integrated pharmaceutical company in 1995. The company offers a broad portfolio across multiple therapeutic ca...
SNJ Labs: WHO-GMP certified API leader in India, specializing in bulk drugs & intermediates with unmatched expertise.
About the Company : SNJ Labs, established in 2013, is India’s largest manufacturer of Iron Sucrose, achieving a production capacity of 120 MT per year within five years. The company specializes in A...
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DOSAGE - SOLUTION;ORAL - 10MG/5ML
USFDA APPLICATION NUMBER - 208193
DOSAGE - SOLUTION;ORAL - 5MG/5ML
USFDA APPLICATION NUMBER - 208193
DOSAGE - INJECTABLE;INTRATHECAL - 0.05MG/ML
USFDA APPLICATION NUMBER - 22462
DOSAGE - INJECTABLE;INTRATHECAL - 0.5MG/ML
USFDA APPLICATION NUMBER - 22462
DOSAGE - INJECTABLE;INTRATHECAL - 1MG/ML
USFDA APPLICATION NUMBER - 22462
DOSAGE - INJECTABLE;INTRATHECAL - 2MG/ML
USFDA APPLICATION NUMBER - 22462
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Disintegrants & Superdisintegrants
Direct Compression
Granulation
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Solubilizers
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Parenteral
Taste Masking
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Coating Systems & Additives
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Rheology Modifiers
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Global Sales Information
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REF. STANDARDS & IMPURITIES
ABOUT THIS PAGE
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PharmaCompass offers a list of Baclofen 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 Baclofen manufacturer or Baclofen supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Baclofen manufacturer or Baclofen supplier.
A Atrofen manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Atrofen, including repackagers and relabelers. The FDA regulates Atrofen manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Atrofen 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 Atrofen manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Atrofen supplier is an individual or a company that provides Atrofen active pharmaceutical ingredient (API) or Atrofen finished formulations upon request. The Atrofen suppliers may include Atrofen API manufacturers, exporters, distributors and traders.
click here to find a list of Atrofen suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Atrofen DMF (Drug Master File) is a document detailing the whole manufacturing process of Atrofen active pharmaceutical ingredient (API) in detail. Different forms of Atrofen DMFs exist exist since differing nations have different regulations, such as Atrofen USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Atrofen DMF submitted to regulatory agencies in the US is known as a USDMF. Atrofen USDMF includes data on Atrofen's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Atrofen USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Atrofen 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 Atrofen Drug Master File in Japan (Atrofen JDMF) empowers Atrofen 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 Atrofen JDMF during the approval evaluation for pharmaceutical products. At the time of Atrofen 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 Atrofen 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 Atrofen Drug Master File in Korea (Atrofen KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Atrofen. The MFDS reviews the Atrofen KDMF as part of the drug registration process and uses the information provided in the Atrofen KDMF to evaluate the safety and efficacy of the drug.
After submitting a Atrofen 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 Atrofen API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Atrofen suppliers with KDMF on PharmaCompass.
A Atrofen CEP of the European Pharmacopoeia monograph is often referred to as a Atrofen Certificate of Suitability (COS). The purpose of a Atrofen CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Atrofen EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Atrofen to their clients by showing that a Atrofen CEP has been issued for it. The manufacturer submits a Atrofen CEP (COS) as part of the market authorization procedure, and it takes on the role of a Atrofen CEP holder for the record. Additionally, the data presented in the Atrofen CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Atrofen DMF.
A Atrofen CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Atrofen 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 Atrofen suppliers with CEP (COS) on PharmaCompass.
A Atrofen written confirmation (Atrofen WC) is an official document issued by a regulatory agency to a Atrofen manufacturer, verifying that the manufacturing facility of a Atrofen active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Atrofen APIs or Atrofen finished pharmaceutical products to another nation, regulatory agencies frequently require a Atrofen WC (written confirmation) as part of the regulatory process.
click here to find a list of Atrofen 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 Atrofen as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Atrofen 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 Atrofen 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 Atrofen and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Atrofen NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Atrofen suppliers with NDC on PharmaCompass.
Atrofen 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 Atrofen GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Atrofen GMP manufacturer or Atrofen GMP API supplier for your needs.
A Atrofen CoA (Certificate of Analysis) is a formal document that attests to Atrofen's compliance with Atrofen specifications and serves as a tool for batch-level quality control.
Atrofen CoA mostly includes findings from lab analyses of a specific batch. For each Atrofen 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.
Atrofen may be tested according to a variety of international standards, such as European Pharmacopoeia (Atrofen EP), Atrofen JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Atrofen USP).
