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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
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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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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 Alfentanil Hydrochloride manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Alfentanil Hydrochloride, including repackagers and relabelers. The FDA regulates Alfentanil Hydrochloride manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Alfentanil Hydrochloride 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 Alfentanil Hydrochloride manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Alfentanil Hydrochloride supplier is an individual or a company that provides Alfentanil Hydrochloride active pharmaceutical ingredient (API) or Alfentanil Hydrochloride finished formulations upon request. The Alfentanil Hydrochloride suppliers may include Alfentanil Hydrochloride API manufacturers, exporters, distributors and traders.
click here to find a list of Alfentanil Hydrochloride suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Alfentanil Hydrochloride DMF (Drug Master File) is a document detailing the whole manufacturing process of Alfentanil Hydrochloride active pharmaceutical ingredient (API) in detail. Different forms of Alfentanil Hydrochloride DMFs exist exist since differing nations have different regulations, such as Alfentanil Hydrochloride USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Alfentanil Hydrochloride DMF submitted to regulatory agencies in the US is known as a USDMF. Alfentanil Hydrochloride USDMF includes data on Alfentanil Hydrochloride's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Alfentanil Hydrochloride USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Alfentanil Hydrochloride 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 Alfentanil Hydrochloride Drug Master File in Korea (Alfentanil Hydrochloride KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Alfentanil Hydrochloride. The MFDS reviews the Alfentanil Hydrochloride KDMF as part of the drug registration process and uses the information provided in the Alfentanil Hydrochloride KDMF to evaluate the safety and efficacy of the drug.
After submitting a Alfentanil Hydrochloride 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 Alfentanil Hydrochloride API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Alfentanil Hydrochloride suppliers with KDMF on PharmaCompass.
A Alfentanil Hydrochloride CEP of the European Pharmacopoeia monograph is often referred to as a Alfentanil Hydrochloride Certificate of Suitability (COS). The purpose of a Alfentanil Hydrochloride CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Alfentanil Hydrochloride EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Alfentanil Hydrochloride to their clients by showing that a Alfentanil Hydrochloride CEP has been issued for it. The manufacturer submits a Alfentanil Hydrochloride CEP (COS) as part of the market authorization procedure, and it takes on the role of a Alfentanil Hydrochloride CEP holder for the record. Additionally, the data presented in the Alfentanil Hydrochloride CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Alfentanil Hydrochloride DMF.
A Alfentanil Hydrochloride CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Alfentanil Hydrochloride 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 Alfentanil Hydrochloride 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 Alfentanil Hydrochloride as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Alfentanil Hydrochloride 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 Alfentanil Hydrochloride 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 Alfentanil Hydrochloride and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Alfentanil Hydrochloride NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Alfentanil Hydrochloride suppliers with NDC on PharmaCompass.
Alfentanil Hydrochloride 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 Alfentanil Hydrochloride 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 Alfentanil Hydrochloride GMP manufacturer or Alfentanil Hydrochloride GMP API supplier for your needs.
A Alfentanil Hydrochloride CoA (Certificate of Analysis) is a formal document that attests to Alfentanil Hydrochloride's compliance with Alfentanil Hydrochloride specifications and serves as a tool for batch-level quality control.
Alfentanil Hydrochloride CoA mostly includes findings from lab analyses of a specific batch. For each Alfentanil Hydrochloride 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.
Alfentanil Hydrochloride may be tested according to a variety of international standards, such as European Pharmacopoeia (Alfentanil Hydrochloride EP), Alfentanil Hydrochloride JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Alfentanil Hydrochloride USP).
