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API SUPPLIERS
Moehs Group, a reference company in the production of pharmaceutical active ingredients.
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Metrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.
Egis is a Hungarian generic pharma company with 110 years history. Our activities incorporate all areas of the pharma value chain.
HRV Pharma - Market Expansion Leader in Pharmaceuticals.
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
Maithri Drugs: Delivering Trusted, High-Quality APIs to 35+ Countries with Innovation, Compliance, and Excellence.
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USDMF
Moehs Group, a reference company in the production of pharmaceutical active ingredients.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 38879
Submission : 2023-09-15
Status :
Type : II
Maithri Drugs: Delivering Trusted, High-Quality APIs to 35+ Countries with Innovation, Compliance, and Excellence.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 41402
Submission : 2025-02-28
Status :
Type : II
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PharmaCompass offers a list of Abrocitinib 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 Abrocitinib manufacturer or Abrocitinib supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Abrocitinib manufacturer or Abrocitinib supplier.
PharmaCompass also assists you with knowing the Abrocitinib API Price utilized in the formulation of products. Abrocitinib API Price is not always fixed or binding as the Abrocitinib Price is obtained through a variety of data sources. The Abrocitinib Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Abrocitinib manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Abrocitinib, including repackagers and relabelers. The FDA regulates Abrocitinib manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Abrocitinib 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 Abrocitinib manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Abrocitinib supplier is an individual or a company that provides Abrocitinib active pharmaceutical ingredient (API) or Abrocitinib finished formulations upon request. The Abrocitinib suppliers may include Abrocitinib API manufacturers, exporters, distributors and traders.
click here to find a list of Abrocitinib suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Abrocitinib DMF (Drug Master File) is a document detailing the whole manufacturing process of Abrocitinib active pharmaceutical ingredient (API) in detail. Different forms of Abrocitinib DMFs exist exist since differing nations have different regulations, such as Abrocitinib USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Abrocitinib DMF submitted to regulatory agencies in the US is known as a USDMF. Abrocitinib USDMF includes data on Abrocitinib's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Abrocitinib USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Abrocitinib suppliers with USDMF 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 Abrocitinib Drug Master File in Korea (Abrocitinib KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Abrocitinib. The MFDS reviews the Abrocitinib KDMF as part of the drug registration process and uses the information provided in the Abrocitinib KDMF to evaluate the safety and efficacy of the drug.
After submitting a Abrocitinib 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 Abrocitinib API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Abrocitinib suppliers with KDMF on PharmaCompass.
Abrocitinib 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 Abrocitinib 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 Abrocitinib GMP manufacturer or Abrocitinib GMP API supplier for your needs.
A Abrocitinib CoA (Certificate of Analysis) is a formal document that attests to Abrocitinib's compliance with Abrocitinib specifications and serves as a tool for batch-level quality control.
Abrocitinib CoA mostly includes findings from lab analyses of a specific batch. For each Abrocitinib 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.
Abrocitinib may be tested according to a variety of international standards, such as European Pharmacopoeia (Abrocitinib EP), Abrocitinib JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Abrocitinib USP).
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