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DRUG PRODUCT COMPOSITIONS0
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API SUPPLIERS
Suanfarma, at the Core of a Better Life.
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JDMF
NDC
KDMF
Capital Farma, a leading European pharmaceutical company focusing on the development & distribution of niche APIs & Pharma Services.
Sumar Biotech work together to Innovate & Manufacture Semi-synthetic, Synthetic & Fermentation API.
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USDMF
Suanfarma, at the Core of a Better Life.
GDUFA
DMF Review : Complete
Rev. Date : 2013-07-02
Pay. Date : 2013-06-20
DMF Number : 13758
Submission : 1998-09-01
Status :
Type : II
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DOSAGE - INJECTABLE;INJECTION - EQ 100MG BASE...DOSAGE - INJECTABLE;INJECTION - EQ 100MG BASE/VIAL
USFDA APPLICATION NUMBER - 50444
DOSAGE - CAPSULE;ORAL - EQ 100MG BASE
USFDA APPLICATION NUMBER - 50649
DOSAGE - CAPSULE;ORAL - EQ 50MG BASE
USFDA APPLICATION NUMBER - 50649
DOSAGE - CAPSULE;ORAL - EQ 75MG BASE **Federa...DOSAGE - CAPSULE;ORAL - EQ 75MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 50649
DOSAGE - POWDER, EXTENDED RELEASE;DENTAL - EQ...DOSAGE - POWDER, EXTENDED RELEASE;DENTAL - EQ 1MG BASE
USFDA APPLICATION NUMBER - 50781
DOSAGE - TABLET, EXTENDED RELEASE;ORAL - EQ 1...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - EQ 105MG BASE
USFDA APPLICATION NUMBER - 50808
DOSAGE - TABLET, EXTENDED RELEASE;ORAL - EQ 1...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - EQ 115MG BASE
USFDA APPLICATION NUMBER - 50808
DOSAGE - TABLET, EXTENDED RELEASE;ORAL - EQ 1...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - EQ 135MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 50808
DOSAGE - TABLET, EXTENDED RELEASE;ORAL - EQ 4...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - EQ 45MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 50808
DOSAGE - TABLET, EXTENDED RELEASE;ORAL - EQ 5...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - EQ 55MG BASE
USFDA APPLICATION NUMBER - 50808
DOSAGE - TABLET, EXTENDED RELEASE;ORAL - EQ 6...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - EQ 65MG BASE
USFDA APPLICATION NUMBER - 50808
DOSAGE - TABLET, EXTENDED RELEASE;ORAL - EQ 8...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - EQ 80MG BASE
USFDA APPLICATION NUMBER - 50808
DOSAGE - TABLET, EXTENDED RELEASE;ORAL - EQ 9...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - EQ 90MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 50808
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ABOUT THIS PAGE
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PharmaCompass offers a list of Minocycline Hydrochloride 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 Minocycline Hydrochloride manufacturer or Minocycline Hydrochloride supplier for your needs.
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A FXFM-244 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of FXFM-244, including repackagers and relabelers. The FDA regulates FXFM-244 manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. FXFM-244 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 FXFM-244 manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A FXFM-244 supplier is an individual or a company that provides FXFM-244 active pharmaceutical ingredient (API) or FXFM-244 finished formulations upon request. The FXFM-244 suppliers may include FXFM-244 API manufacturers, exporters, distributors and traders.
click here to find a list of FXFM-244 suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A FXFM-244 DMF (Drug Master File) is a document detailing the whole manufacturing process of FXFM-244 active pharmaceutical ingredient (API) in detail. Different forms of FXFM-244 DMFs exist exist since differing nations have different regulations, such as FXFM-244 USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A FXFM-244 DMF submitted to regulatory agencies in the US is known as a USDMF. FXFM-244 USDMF includes data on FXFM-244's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The FXFM-244 USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of FXFM-244 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 FXFM-244 Drug Master File in Japan (FXFM-244 JDMF) empowers FXFM-244 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 FXFM-244 JDMF during the approval evaluation for pharmaceutical products. At the time of FXFM-244 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 FXFM-244 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 FXFM-244 Drug Master File in Korea (FXFM-244 KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of FXFM-244. The MFDS reviews the FXFM-244 KDMF as part of the drug registration process and uses the information provided in the FXFM-244 KDMF to evaluate the safety and efficacy of the drug.
After submitting a FXFM-244 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 FXFM-244 API can apply through the Korea Drug Master File (KDMF).
click here to find a list of FXFM-244 suppliers with KDMF on PharmaCompass.
A FXFM-244 CEP of the European Pharmacopoeia monograph is often referred to as a FXFM-244 Certificate of Suitability (COS). The purpose of a FXFM-244 CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of FXFM-244 EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of FXFM-244 to their clients by showing that a FXFM-244 CEP has been issued for it. The manufacturer submits a FXFM-244 CEP (COS) as part of the market authorization procedure, and it takes on the role of a FXFM-244 CEP holder for the record. Additionally, the data presented in the FXFM-244 CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the FXFM-244 DMF.
A FXFM-244 CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. FXFM-244 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 FXFM-244 suppliers with CEP (COS) 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 FXFM-244 as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for FXFM-244 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 FXFM-244 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 FXFM-244 and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a FXFM-244 NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of FXFM-244 suppliers with NDC on PharmaCompass.
FXFM-244 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 FXFM-244 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 FXFM-244 GMP manufacturer or FXFM-244 GMP API supplier for your needs.
A FXFM-244 CoA (Certificate of Analysis) is a formal document that attests to FXFM-244's compliance with FXFM-244 specifications and serves as a tool for batch-level quality control.
FXFM-244 CoA mostly includes findings from lab analyses of a specific batch. For each FXFM-244 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.
FXFM-244 may be tested according to a variety of international standards, such as European Pharmacopoeia (FXFM-244 EP), FXFM-244 JP (Japanese Pharmacopeia) and the US Pharmacopoeia (FXFM-244 USP).
