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VMF
DRUG PRODUCT COMPOSITIONS0
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API SUPPLIERS
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USDMF
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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**Federa...DOSAGE - CAPSULE;ORAL - EQ 75MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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- TABLET, EXTENDED RELEASE;ORAL - EQ 135MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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- TABLET, EXTENDED RELEASE;ORAL - EQ 45MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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- TABLET, EXTENDED RELEASE;ORAL - EQ 90MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Minocycline Hydrochloride manufacturer or Minocycline Hydrochloride supplier.
PharmaCompass also assists you with knowing the Minocycline Hydrochloride API Price utilized in the formulation of products. Minocycline Hydrochloride API Price is not always fixed or binding as the Minocycline Hydrochloride Price is obtained through a variety of data sources. The Minocycline Hydrochloride Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Minocycline HCl manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Minocycline HCl, including repackagers and relabelers. The FDA regulates Minocycline HCl manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Minocycline HCl 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 Minocycline HCl manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Minocycline HCl supplier is an individual or a company that provides Minocycline HCl active pharmaceutical ingredient (API) or Minocycline HCl finished formulations upon request. The Minocycline HCl suppliers may include Minocycline HCl API manufacturers, exporters, distributors and traders.
click here to find a list of Minocycline HCl suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Minocycline HCl DMF (Drug Master File) is a document detailing the whole manufacturing process of Minocycline HCl active pharmaceutical ingredient (API) in detail. Different forms of Minocycline HCl DMFs exist exist since differing nations have different regulations, such as Minocycline HCl USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Minocycline HCl DMF submitted to regulatory agencies in the US is known as a USDMF. Minocycline HCl USDMF includes data on Minocycline HCl's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Minocycline HCl USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Minocycline HCl 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 Minocycline HCl Drug Master File in Japan (Minocycline HCl JDMF) empowers Minocycline HCl 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 Minocycline HCl JDMF during the approval evaluation for pharmaceutical products. At the time of Minocycline HCl 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 Minocycline HCl 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 Minocycline HCl Drug Master File in Korea (Minocycline HCl KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Minocycline HCl. The MFDS reviews the Minocycline HCl KDMF as part of the drug registration process and uses the information provided in the Minocycline HCl KDMF to evaluate the safety and efficacy of the drug.
After submitting a Minocycline HCl 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 Minocycline HCl API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Minocycline HCl suppliers with KDMF on PharmaCompass.
A Minocycline HCl CEP of the European Pharmacopoeia monograph is often referred to as a Minocycline HCl Certificate of Suitability (COS). The purpose of a Minocycline HCl CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Minocycline HCl EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Minocycline HCl to their clients by showing that a Minocycline HCl CEP has been issued for it. The manufacturer submits a Minocycline HCl CEP (COS) as part of the market authorization procedure, and it takes on the role of a Minocycline HCl CEP holder for the record. Additionally, the data presented in the Minocycline HCl CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Minocycline HCl DMF.
A Minocycline HCl CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Minocycline HCl 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 Minocycline HCl 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 Minocycline HCl as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Minocycline HCl 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 Minocycline HCl 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 Minocycline HCl and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Minocycline HCl NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Minocycline HCl suppliers with NDC on PharmaCompass.
Minocycline HCl 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 Minocycline HCl 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 Minocycline HCl GMP manufacturer or Minocycline HCl GMP API supplier for your needs.
A Minocycline HCl CoA (Certificate of Analysis) is a formal document that attests to Minocycline HCl's compliance with Minocycline HCl specifications and serves as a tool for batch-level quality control.
Minocycline HCl CoA mostly includes findings from lab analyses of a specific batch. For each Minocycline HCl 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.
Minocycline HCl may be tested according to a variety of international standards, such as European Pharmacopoeia (Minocycline HCl EP), Minocycline HCl JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Minocycline HCl USP).
