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DRUG PRODUCT COMPOSITIONS0
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API SUPPLIERS
Suanfarma, at the Core of a Better Life.
Curia - Accelerating therapies from discovery to commercialization with flexible, scalable CDMO solutions.
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.
Together we can improve the quality of life
Curia - Accelerating therapies from discovery to commercialization with flexible, scalable CDMO solutions.
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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
Curia - Accelerating therapies from discovery to commercialization with flexible, scalable CDMO solutions.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 33279
Submission : 2018-11-28
Status :
Type : II
Curia - Accelerating therapies from discovery to commercialization with flexible, scalable CDMO solutions.
GDUFA
DMF Review : Complete
Rev. Date : 2013-01-30
Pay. Date : 2013-01-16
DMF Number : 14802
Submission : 2000-03-22
Status :
Type : II
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Suanfarma, at the Core of a Better Life.
Minocycline Hydrochloride Dihydrate
Certificate Number : R1-CEP 1999-002 - Rev 06
Status : Valid
Issue Date : 2022-12-02
Type : Chemical
Substance Number : 1030
Curia - Accelerating therapies from discovery to commercialization with flexible, scalable CDMO solutions.
Minocycline Hydrochloride Dihydrate
Certificate Number : CEP 2000-107 - Rev 10
Status : Valid
Issue Date : 2024-02-27
Type : Chemical
Substance Number : 1030
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results] JDMF
Suanfarma, at the Core of a Better Life.
Registration Number : 304MF10123
Registrant's Address : Rua da Estacao, 1 e 1A, 2600-726 Castanheira do Ribatejo, Portugal
Initial Date of Registration : 2022-08-17
Latest Date of Registration : 2022-08-17
Curia - Accelerating therapies from discovery to commercialization with flexible, scalable CDMO solutions.
Registration Number : 217MF10699
Registrant's Address : Via del Vecchio Politecnico n. 9, 20121 Milano (MI) - Italy
Initial Date of Registration : 2005-10-07
Latest Date of Registration : 2020-01-31
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Suanfarma, at the Core of a Better Life.
Minocycline hydrochloride hydrate
Registrant Name : Sam-O Pharmaceutical Co., Ltd.
Registration Date : 2024-01-31
Registration Number : 20240131-211-J-1572
Manufacturer Name : CIPAN - Companhia Industrial...
Manufacturer Address : Rua da Estação, 1/1A, 2600-726 Castanheira do Ribatejo, Portugal
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Suanfarma, at the Core of a Better Life.
About the Company : Suanfarma is a B2B life sciences company focused on developing, manufacturing, and distributing high-quality ingredients for the pharmaceutical industry in an innovative and sustai...
Curia - Accelerating therapies from discovery to commercialization with flexible, scalable CDMO solutions.
About the Company : Curia is a leading global CDMO with over 30 years of experience supporting clients across drug discovery, development, and commercial manufacturing. Leveraging deep scientific expe...
Capital Farma, a leading European pharmaceutical company focusing on the development & distribution of niche APIs & Pharma Services.
About the Company : Capital Farma provides integrated pharmaceutical solutions with a focus on high-quality Active Pharmaceutical Ingredients (APIs) sourced from leading European manufacturers. The co...
Sumar Biotech work together to Innovate & Manufacture Semi-synthetic, Synthetic & Fermentation API.
About the Company : Sumar Biotech LLP, registered in January 2018, is a startup approved by the Gujarat State Biotechnology Mission. Founded by young entrepreneurs and experienced research and manufac...
Together we can improve the quality of life
About the Company : Shamrock Pharmachemi Pvt Ltd. is a globally recognized API leader with 26+ years in human and veterinary pharmaceuticals. Operating in 40+ countries, it owns two Gujarat facilities...
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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 **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 1...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - EQ 115MG 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 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 **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 6...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - EQ 65MG 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 8...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - EQ 80MG 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 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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ANALYTICAL
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, 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.
A Akamin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Akamin, including repackagers and relabelers. The FDA regulates Akamin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Akamin 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 Akamin manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Akamin supplier is an individual or a company that provides Akamin active pharmaceutical ingredient (API) or Akamin finished formulations upon request. The Akamin suppliers may include Akamin API manufacturers, exporters, distributors and traders.
click here to find a list of Akamin suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Akamin DMF (Drug Master File) is a document detailing the whole manufacturing process of Akamin active pharmaceutical ingredient (API) in detail. Different forms of Akamin DMFs exist exist since differing nations have different regulations, such as Akamin USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Akamin DMF submitted to regulatory agencies in the US is known as a USDMF. Akamin USDMF includes data on Akamin's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Akamin USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Akamin 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 Akamin Drug Master File in Japan (Akamin JDMF) empowers Akamin 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 Akamin JDMF during the approval evaluation for pharmaceutical products. At the time of Akamin 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 Akamin 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 Akamin Drug Master File in Korea (Akamin KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Akamin. The MFDS reviews the Akamin KDMF as part of the drug registration process and uses the information provided in the Akamin KDMF to evaluate the safety and efficacy of the drug.
After submitting a Akamin 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 Akamin API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Akamin suppliers with KDMF on PharmaCompass.
A Akamin CEP of the European Pharmacopoeia monograph is often referred to as a Akamin Certificate of Suitability (COS). The purpose of a Akamin CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Akamin EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Akamin to their clients by showing that a Akamin CEP has been issued for it. The manufacturer submits a Akamin CEP (COS) as part of the market authorization procedure, and it takes on the role of a Akamin CEP holder for the record. Additionally, the data presented in the Akamin CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Akamin DMF.
A Akamin CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Akamin 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 Akamin 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 Akamin as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Akamin 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 Akamin 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 Akamin and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Akamin NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Akamin suppliers with NDC on PharmaCompass.
Akamin 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 Akamin GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Akamin GMP manufacturer or Akamin GMP API supplier for your needs.
A Akamin CoA (Certificate of Analysis) is a formal document that attests to Akamin's compliance with Akamin specifications and serves as a tool for batch-level quality control.
Akamin CoA mostly includes findings from lab analyses of a specific batch. For each Akamin 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.
Akamin may be tested according to a variety of international standards, such as European Pharmacopoeia (Akamin EP), Akamin JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Akamin USP).
