Synopsis
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VMF
DRUG PRODUCT COMPOSITIONS0
Stock Recap #PipelineProspector
API SUPPLIERS
Apex Healthcare Limited: ISO 9001:2008, WHO-GMP, US FDA-audited manufacturer & exporter of APIs, bulk drugs, and formulations.
Vital Laboratories – Trusted Global API Manufacturer of Quinine, Hyoscine, Antimalarials & Vitamins
MX 
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
IKF/Pharmasynthese have been with fine chemicals market and APIs performance for more than 40 years.
Rochem, your partner in developing, sourcing, and supplying pharmaceutical & animal health ingredients of Chinese origin.
Temad- We think of world-class quality.
Gonane has API manufacturing expertise in new-age Corticosteroids, Hormones and other pharma raw materials.
Jai Radhe Sales is your partner for all your sourcing needs.
HRV Pharma - Market Expansion Leader in Pharmaceuticals.
Since 1980, Octavius Pharma has been empowering lives by delivering trusted healthcare solutions, including DC granules, APIs, and FDFs
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USDMF
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EUROAPI, the leading small molecules API player, provides both API sales & CDMO services.
5'-Chloro-2'-nitro-N-phenylmalonanilic acid ethyl ...
CAS Number : 22316-45-6
End Use API : Acyclovir
About The Company : EUROAPI focuses on reinventing active ingredient solutions to sustainably meet the needs of customers and patients worldwide. The company is a leading API playe...
Together we can improve the quality of life
CAS Number : 75128-73-3
End Use API : Acyclovir
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 tw...
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DOSAGE - CAPSULE;ORAL - 200MG **Federal Regis...DOSAGE - CAPSULE;ORAL - 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 18828
DOSAGE - SUSPENSION;ORAL - 200MG/5ML **Federa...DOSAGE - SUSPENSION;ORAL - 200MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 19909
DOSAGE - TABLET;ORAL - 400MG **Federal Regist...DOSAGE - TABLET;ORAL - 400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 20089
DOSAGE - TABLET;ORAL - 800MG **Federal Regist...DOSAGE - TABLET;ORAL - 800MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 20089
DOSAGE - CREAM;TOPICAL - 5%;1%
USFDA APPLICATION NUMBER - 22436
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ANALYTICAL
ABOUT THIS PAGE
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PharmaCompass offers a list of Acyclovir 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 Acyclovir manufacturer or Acyclovir supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Acyclovir manufacturer or Acyclovir supplier.
A DivK1c_000185 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of DivK1c_000185, including repackagers and relabelers. The FDA regulates DivK1c_000185 manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. DivK1c_000185 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 DivK1c_000185 manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A DivK1c_000185 supplier is an individual or a company that provides DivK1c_000185 active pharmaceutical ingredient (API) or DivK1c_000185 finished formulations upon request. The DivK1c_000185 suppliers may include DivK1c_000185 API manufacturers, exporters, distributors and traders.
click here to find a list of DivK1c_000185 suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A DivK1c_000185 DMF (Drug Master File) is a document detailing the whole manufacturing process of DivK1c_000185 active pharmaceutical ingredient (API) in detail. Different forms of DivK1c_000185 DMFs exist exist since differing nations have different regulations, such as DivK1c_000185 USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A DivK1c_000185 DMF submitted to regulatory agencies in the US is known as a USDMF. DivK1c_000185 USDMF includes data on DivK1c_000185's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The DivK1c_000185 USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of DivK1c_000185 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 DivK1c_000185 Drug Master File in Japan (DivK1c_000185 JDMF) empowers DivK1c_000185 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 DivK1c_000185 JDMF during the approval evaluation for pharmaceutical products. At the time of DivK1c_000185 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 DivK1c_000185 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 DivK1c_000185 Drug Master File in Korea (DivK1c_000185 KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of DivK1c_000185. The MFDS reviews the DivK1c_000185 KDMF as part of the drug registration process and uses the information provided in the DivK1c_000185 KDMF to evaluate the safety and efficacy of the drug.
After submitting a DivK1c_000185 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 DivK1c_000185 API can apply through the Korea Drug Master File (KDMF).
click here to find a list of DivK1c_000185 suppliers with KDMF on PharmaCompass.
A DivK1c_000185 CEP of the European Pharmacopoeia monograph is often referred to as a DivK1c_000185 Certificate of Suitability (COS). The purpose of a DivK1c_000185 CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of DivK1c_000185 EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of DivK1c_000185 to their clients by showing that a DivK1c_000185 CEP has been issued for it. The manufacturer submits a DivK1c_000185 CEP (COS) as part of the market authorization procedure, and it takes on the role of a DivK1c_000185 CEP holder for the record. Additionally, the data presented in the DivK1c_000185 CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the DivK1c_000185 DMF.
A DivK1c_000185 CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. DivK1c_000185 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 DivK1c_000185 suppliers with CEP (COS) on PharmaCompass.
A DivK1c_000185 written confirmation (DivK1c_000185 WC) is an official document issued by a regulatory agency to a DivK1c_000185 manufacturer, verifying that the manufacturing facility of a DivK1c_000185 active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting DivK1c_000185 APIs or DivK1c_000185 finished pharmaceutical products to another nation, regulatory agencies frequently require a DivK1c_000185 WC (written confirmation) as part of the regulatory process.
click here to find a list of DivK1c_000185 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 DivK1c_000185 as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for DivK1c_000185 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 DivK1c_000185 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 DivK1c_000185 and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a DivK1c_000185 NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of DivK1c_000185 suppliers with NDC on PharmaCompass.
DivK1c_000185 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 DivK1c_000185 GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right DivK1c_000185 GMP manufacturer or DivK1c_000185 GMP API supplier for your needs.
A DivK1c_000185 CoA (Certificate of Analysis) is a formal document that attests to DivK1c_000185's compliance with DivK1c_000185 specifications and serves as a tool for batch-level quality control.
DivK1c_000185 CoA mostly includes findings from lab analyses of a specific batch. For each DivK1c_000185 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.
DivK1c_000185 may be tested according to a variety of international standards, such as European Pharmacopoeia (DivK1c_000185 EP), DivK1c_000185 JP (Japanese Pharmacopeia) and the US Pharmacopoeia (DivK1c_000185 USP).
