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API SUPPLIERS
Minakem delivers API, HPAPI, steroids & CDMO services for generics with FDA/GMP certification, regulatory know-how & proven success.
KDMF
Veranova: A CDMO that manages complexity with confidence.
CEP/COS
NDC
KDMF
ROW
Minakem is manufacturing small molecules APIs including corticosteroids
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
Aspen API. More than just an API.
ASMF
NDC
KDMF
Rusan Pharma: Over 30 years of specializing in the treatment of Addiction and Pain Management.
Tofigh Daru develops & synthesizes a diverse range of APIs in Anticancer, Narcotics, Cardiovascular to Immunomodulatory Segments.
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USDMF
Veranova: A CDMO that manages complexity with confidence.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 25811
Submission : 2011-12-22
Status :
Type : II
Aspen API. More than just an API.
GDUFA
DMF Review : Complete
Rev. Date : 2015-03-30
Pay. Date : 2014-12-04
DMF Number : 28106
Submission : 2014-03-13
Status :
Type : II
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Minakem delivers API, HPAPI, steroids & CDMO services for generics with FDA/GMP certification, regulatory know-how & proven success.
Certificate Number : R0-CEP 2020-323 - Rev 00
Status : Valid
Issue Date : 2022-03-14
Type : Chemical
Substance Number : 2644
Veranova: A CDMO that manages complexity with confidence.
Certificate Number : CEP 2018-137 - Rev 01
Status : Valid
Issue Date : 2024-08-06
Type : Chemical
Substance Number : 2644
Certificate Number : CEP 2018-240 - Rev 03
Status : Valid
Issue Date : 2024-06-28
Type : Chemical
Substance Number : 2644
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Minakem delivers API, HPAPI, steroids & CDMO services for generics with FDA/GMP certification, regulatory know-how & proven success.
Registrant Name : Mitsubishi Tanabe Pharma Korea Co., Ltd.
Registration Date : 2014-10-28
Registration Number : Su2480-16-ND
Manufacturer Name : Minakem High Potent SA
Manufacturer Address : Rue Fonds Jean Paques 8, Mont-Saint-Guibert, 1435 Belgium
Veranova: A CDMO that manages complexity with confidence.
Registrant Name : Samung Industrial Co., Ltd.
Registration Date : 2014-09-02
Registration Number : Number 5-1-ND
Manufacturer Name : Macfarlan Smith Ltd.
Manufacturer Address : 10 Wheatfield Road, Edinburgh, EH11 2QA, United Kingdom_x000D_
Veranova: A CDMO that manages complexity with confidence.
Registrant Name : Nosa Chemical Co., Ltd.
Registration Date : 2014-09-02
Registration Number : Number 5-1-ND(2)
Manufacturer Name : Macfarlan Smith Ltd.
Manufacturer Address : 10 Wheatfield Road, Edinburgh, EH11 2QA, United Kingdom
Veranova: A CDMO that manages complexity with confidence.
Registrant Name : Baeksu Pharmaceutical Co., Ltd.
Registration Date : 2014-09-02
Registration Number : Number 5-1-ND(1)
Manufacturer Name : Macfarlan Smith Ltd.
Manufacturer Address : 10 Wheatfield Road, Edinburgh, EH11 2QA, United Kingdom
Registrant Name : Aging Life Science Co., Ltd.
Registration Date : 2019-02-26
Registration Number : No. 181-3-ND(1)
Manufacturer Name : Fine Chemicals Corporation
Manufacturer Address : 15 Hawkins Avenue, Epping 1, Cape Town, 7460, South Africa
Registrant Name : Fresenius Kabi Korea Co., Ltd.
Registration Date : 2016-08-18
Registration Number : Su181-3-ND
Manufacturer Name : Fine Chemicals Corporation (...
Manufacturer Address : 15 Hawkins Avenue, Epping 1, Cape Town, 7460, South Africa
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INTERMEDIATES SUPPLIERS
Malladi is a leader in Ephedrine, Pseudoephedrine Salts & Phenylephrine HCl // USFDA, EDQM, ANSM, KFDA, and TGA inspected.
Methyl 1-(phenylmethyl)-4-(phenylamino)-piperidine...
CAS Number : 61085-60-7
End Use API : Remifentanil
About The Company : Malladi Drugs & Pharmaceuticals Ltd was founded in 1980 by microbiologist Mr. M L N Sastry. Within a few years, Malladi established itself as a leader in manufa...
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REF. STANDARDS & IMPURITIES
ABOUT THIS PAGE
A Remifentanil manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Remifentanil, including repackagers and relabelers. The FDA regulates Remifentanil manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Remifentanil 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 Remifentanil manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Remifentanil supplier is an individual or a company that provides Remifentanil active pharmaceutical ingredient (API) or Remifentanil finished formulations upon request. The Remifentanil suppliers may include Remifentanil API manufacturers, exporters, distributors and traders.
click here to find a list of Remifentanil suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Remifentanil DMF (Drug Master File) is a document detailing the whole manufacturing process of Remifentanil active pharmaceutical ingredient (API) in detail. Different forms of Remifentanil DMFs exist exist since differing nations have different regulations, such as Remifentanil USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Remifentanil DMF submitted to regulatory agencies in the US is known as a USDMF. Remifentanil USDMF includes data on Remifentanil's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Remifentanil USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Remifentanil 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 Remifentanil Drug Master File in Japan (Remifentanil JDMF) empowers Remifentanil 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 Remifentanil JDMF during the approval evaluation for pharmaceutical products. At the time of Remifentanil 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 Remifentanil 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 Remifentanil Drug Master File in Korea (Remifentanil KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Remifentanil. The MFDS reviews the Remifentanil KDMF as part of the drug registration process and uses the information provided in the Remifentanil KDMF to evaluate the safety and efficacy of the drug.
After submitting a Remifentanil 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 Remifentanil API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Remifentanil suppliers with KDMF on PharmaCompass.
A Remifentanil CEP of the European Pharmacopoeia monograph is often referred to as a Remifentanil Certificate of Suitability (COS). The purpose of a Remifentanil CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Remifentanil EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Remifentanil to their clients by showing that a Remifentanil CEP has been issued for it. The manufacturer submits a Remifentanil CEP (COS) as part of the market authorization procedure, and it takes on the role of a Remifentanil CEP holder for the record. Additionally, the data presented in the Remifentanil CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Remifentanil DMF.
A Remifentanil CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Remifentanil 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 Remifentanil suppliers with CEP (COS) on PharmaCompass.
A Remifentanil written confirmation (Remifentanil WC) is an official document issued by a regulatory agency to a Remifentanil manufacturer, verifying that the manufacturing facility of a Remifentanil active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Remifentanil APIs or Remifentanil finished pharmaceutical products to another nation, regulatory agencies frequently require a Remifentanil WC (written confirmation) as part of the regulatory process.
click here to find a list of Remifentanil 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 Remifentanil as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Remifentanil 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 Remifentanil 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 Remifentanil and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Remifentanil NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Remifentanil suppliers with NDC on PharmaCompass.
Remifentanil 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 Remifentanil 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 Remifentanil GMP manufacturer or Remifentanil GMP API supplier for your needs.
A Remifentanil CoA (Certificate of Analysis) is a formal document that attests to Remifentanil's compliance with Remifentanil specifications and serves as a tool for batch-level quality control.
Remifentanil CoA mostly includes findings from lab analyses of a specific batch. For each Remifentanil 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.
Remifentanil may be tested according to a variety of international standards, such as European Pharmacopoeia (Remifentanil EP), Remifentanil JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Remifentanil USP).
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