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API SUPPLIERS
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USDMF
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
GDUFA
DMF Review : Complete
Rev. Date : 2014-06-24
Pay. Date : 2014-02-24
DMF Number : 27945
Submission : 2014-04-13
Status :
Type : II
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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, ...
Symbiotec: Global API manufacturer, specializing in Cortico-Steroids & Steroid-Hormone APIs.
About the Company : Symbiotec, a leading API manufacturing company based in Indore, Central India, specializes in Cortico-Steroids and Steroid-Hormone APIs. Since 1995, their focus on R&D, sustainable...
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...
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Boai NKY Pharmaceuticals Ltd
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ABOUT THIS PAGE
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PharmaCompass offers a list of Ulipristal Acetate 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 Ulipristal Acetate manufacturer or Ulipristal Acetate supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Ulipristal Acetate manufacturer or Ulipristal Acetate supplier.
PharmaCompass also assists you with knowing the Ulipristal Acetate API Price utilized in the formulation of products. Ulipristal Acetate API Price is not always fixed or binding as the Ulipristal Acetate Price is obtained through a variety of data sources. The Ulipristal Acetate Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A LOGILIA manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of LOGILIA, including repackagers and relabelers. The FDA regulates LOGILIA manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. LOGILIA 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 LOGILIA manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A LOGILIA supplier is an individual or a company that provides LOGILIA active pharmaceutical ingredient (API) or LOGILIA finished formulations upon request. The LOGILIA suppliers may include LOGILIA API manufacturers, exporters, distributors and traders.
click here to find a list of LOGILIA suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A LOGILIA DMF (Drug Master File) is a document detailing the whole manufacturing process of LOGILIA active pharmaceutical ingredient (API) in detail. Different forms of LOGILIA DMFs exist exist since differing nations have different regulations, such as LOGILIA USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A LOGILIA DMF submitted to regulatory agencies in the US is known as a USDMF. LOGILIA USDMF includes data on LOGILIA's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The LOGILIA USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of LOGILIA 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 LOGILIA Drug Master File in Japan (LOGILIA JDMF) empowers LOGILIA 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 LOGILIA JDMF during the approval evaluation for pharmaceutical products. At the time of LOGILIA 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 LOGILIA 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 LOGILIA Drug Master File in Korea (LOGILIA KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of LOGILIA. The MFDS reviews the LOGILIA KDMF as part of the drug registration process and uses the information provided in the LOGILIA KDMF to evaluate the safety and efficacy of the drug.
After submitting a LOGILIA 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 LOGILIA API can apply through the Korea Drug Master File (KDMF).
click here to find a list of LOGILIA suppliers with KDMF on PharmaCompass.
A LOGILIA written confirmation (LOGILIA WC) is an official document issued by a regulatory agency to a LOGILIA manufacturer, verifying that the manufacturing facility of a LOGILIA active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting LOGILIA APIs or LOGILIA finished pharmaceutical products to another nation, regulatory agencies frequently require a LOGILIA WC (written confirmation) as part of the regulatory process.
click here to find a list of LOGILIA 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 LOGILIA as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for LOGILIA 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 LOGILIA 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 LOGILIA and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a LOGILIA NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of LOGILIA suppliers with NDC on PharmaCompass.
LOGILIA 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 LOGILIA 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 LOGILIA GMP manufacturer or LOGILIA GMP API supplier for your needs.
A LOGILIA CoA (Certificate of Analysis) is a formal document that attests to LOGILIA's compliance with LOGILIA specifications and serves as a tool for batch-level quality control.
LOGILIA CoA mostly includes findings from lab analyses of a specific batch. For each LOGILIA 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.
LOGILIA may be tested according to a variety of international standards, such as European Pharmacopoeia (LOGILIA EP), LOGILIA JP (Japanese Pharmacopeia) and the US Pharmacopoeia (LOGILIA USP).
