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DRUG PRODUCT COMPOSITIONS
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API SUPPLIERS
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USDMF
Veranova: A CDMO that manages complexity with confidence.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 12661
Submission : 1997-09-19
Status :
Type : II
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]CEP/COS
Veranova: A CDMO that manages complexity with confidence.
Alfentanil Hydrochloride Hydrate
Certificate Number : R1-CEP 2011-195 - Rev 02
Status : Valid
Issue Date : 2023-08-30
Type : Chemical
Substance Number : 1062
Veranova: A CDMO that manages complexity with confidence.
Alfentanil Hydrochloride Hydrate
Certificate Number : R1-CEP 2010-008 - Rev 03
Status : Valid
Issue Date : 2021-08-03
Type : Chemical
Substance Number : 1062
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results] KDMF
Veranova: A CDMO that manages complexity with confidence.
Registrant Name : Samung Industrial Co., Ltd.
Registration Date : 2022-04-25
Registration Number : 20220422-210-J-1275(A)
Manufacturer Name : Macfarlan Smith Limited
Manufacturer Address : 10 Wheatfield Road, Edinburgh, EH11 2QA, United Kingdom
Veranova: A CDMO that manages complexity with confidence.
Registrant Name : Nosa Chemical Co., Ltd.
Registration Date : 2022-08-29
Registration Number : 20220422-210-J-1275(B)
Manufacturer Name : Macfarlan Smith Limited
Manufacturer Address : 10, Wheatfield Road, Edinburgh EH11 2QA, Scotland, UK
Veranova: A CDMO that manages complexity with confidence.
Registrant Name : Baeksu Pharmaceutical Co., Ltd.
Registration Date : 2022-04-22
Registration Number : 20220422-210-J-1275
Manufacturer Name : Macfarlan Smith Limited
Manufacturer Address : 10 Wheatfield Road, Edinburgh, EH11 2QA, United Kingdom
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]NDC API
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Listed Suppliers
Veranova: A CDMO that manages complexity with confidence.
About the Company : Veranova is a global leader in the development and manufacturing of specialist and complex APIs for pharma and biotech customers. We have over 50 years of experience navigating the...
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]INTERMEDIATE SUPPLIERS
Malladi is a leader in Ephedrine, Pseudoephedrine Salts & Phenylephrine HCl // USFDA, EDQM, ANSM, KFDA, and TGA inspected.
I-Benzyl-4-phenylamino-piperidine-4-carbonitrile
CAS Number : 968-86-5
End Use API : Alfentanil Hydrochloride
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...
Malladi is a leader in Ephedrine, Pseudoephedrine Salts & Phenylephrine HCl // USFDA, EDQM, ANSM, KFDA, and TGA inspected.
1-Benzyl-4-phenylamino-piperidine-4-carboxamide
CAS Number : 1096-03-3
End Use API : Alfentanil Hydrochloride
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...
Malladi is a leader in Ephedrine, Pseudoephedrine Salts & Phenylephrine HCl // USFDA, EDQM, ANSM, KFDA, and TGA inspected.
1-Benzyl-4-phenylamino-piperidine-4-carboxylic aci...
CAS Number : 85098-64-2
End Use API : Alfentanil Hydrochloride
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...
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]FDF Dossiers
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FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Related Excipient Companies
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REF. STANDARDS & IMPURITIES
ABOUT THIS PAGE
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PharmaCompass offers a list of Alfentanil 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 Alfentanil Hydrochloride manufacturer or Alfentanil Hydrochloride supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Alfentanil Hydrochloride manufacturer or Alfentanil Hydrochloride supplier.
PharmaCompass also assists you with knowing the Alfentanil Hydrochloride API Price utilized in the formulation of products. Alfentanil Hydrochloride API Price is not always fixed or binding as the Alfentanil Hydrochloride Price is obtained through a variety of data sources. The Alfentanil Hydrochloride Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Rapifen manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Rapifen, including repackagers and relabelers. The FDA regulates Rapifen manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Rapifen 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 Rapifen manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Rapifen supplier is an individual or a company that provides Rapifen active pharmaceutical ingredient (API) or Rapifen finished formulations upon request. The Rapifen suppliers may include Rapifen API manufacturers, exporters, distributors and traders.
click here to find a list of Rapifen suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Rapifen DMF (Drug Master File) is a document detailing the whole manufacturing process of Rapifen active pharmaceutical ingredient (API) in detail. Different forms of Rapifen DMFs exist exist since differing nations have different regulations, such as Rapifen USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Rapifen DMF submitted to regulatory agencies in the US is known as a USDMF. Rapifen USDMF includes data on Rapifen's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Rapifen USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Rapifen suppliers with USDMF 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 Rapifen Drug Master File in Korea (Rapifen KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Rapifen. The MFDS reviews the Rapifen KDMF as part of the drug registration process and uses the information provided in the Rapifen KDMF to evaluate the safety and efficacy of the drug.
After submitting a Rapifen 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 Rapifen API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Rapifen suppliers with KDMF on PharmaCompass.
A Rapifen CEP of the European Pharmacopoeia monograph is often referred to as a Rapifen Certificate of Suitability (COS). The purpose of a Rapifen CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Rapifen EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Rapifen to their clients by showing that a Rapifen CEP has been issued for it. The manufacturer submits a Rapifen CEP (COS) as part of the market authorization procedure, and it takes on the role of a Rapifen CEP holder for the record. Additionally, the data presented in the Rapifen CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Rapifen DMF.
A Rapifen CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Rapifen 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 Rapifen 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 Rapifen as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Rapifen 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 Rapifen 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 Rapifen and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Rapifen NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Rapifen suppliers with NDC on PharmaCompass.
Rapifen 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 Rapifen 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 Rapifen GMP manufacturer or Rapifen GMP API supplier for your needs.
A Rapifen CoA (Certificate of Analysis) is a formal document that attests to Rapifen's compliance with Rapifen specifications and serves as a tool for batch-level quality control.
Rapifen CoA mostly includes findings from lab analyses of a specific batch. For each Rapifen 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.
Rapifen may be tested according to a variety of international standards, such as European Pharmacopoeia (Rapifen EP), Rapifen JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Rapifen USP).
