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Australia
DRUG PRODUCT COMPOSITIONS0
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Data Compilation #PharmaFlow
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API SUPPLIERS
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USDMF
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Aarti Pharmalabs is a partner of choice for pharmaceutical companies for APIs & Intermediates. Largest Indian producer of Caffeine.
Certificate Number : R1-CEP 2013-245 - Rev 02
Status : Valid
Issue Date : 2022-10-27
Type : Chemical
Substance Number : 2019
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Aarti Pharmalabs is a partner of choice for pharmaceutical companies for APIs & Intermediates. Largest Indian producer of Caffeine.
Perindopril Erbumine BP/Ph. Eur
Date of Issue : 2025-08-22
Valid Till : 2028-08-21
Written Confirmation Number : WC-0099
Address of the Firm : Plot No.E-50, 50/1 and 59/1, Unit-IV, MIDC, Tarapur-401506, Taluka: Palghar, Dis...
Aarti Pharmalabs is a partner of choice for pharmaceutical companies for APIs & Intermediates. Largest Indian producer of Caffeine.
Perindopril Erbumine BP/Ph. Eur
Date of Issue : 2024-05-20
Valid Till : 2027-05-19
Written Confirmation Number : WC-0295
Address of the Firm : D-53, PHASE II, KALYAN SHILL ROAD, DOMBIVLI (E.), DOMBIVLI - 421204, Taluka: Dom...
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DOSAGE - TABLET;ORAL - 2MG
USFDA APPLICATION NUMBER - 20184
DOSAGE - TABLET;ORAL - 4MG
USFDA APPLICATION NUMBER - 20184
DOSAGE - TABLET;ORAL - 8MG
USFDA APPLICATION NUMBER - 20184
Related Excipient Companies
SPI Pharma
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Gangwal Healthcare
Gangwal Healthcare is powered by innovation, driving health, wellness & healing.
Dosage Form : Tablet
Grade : Oral
Gangwal Healthcare is powered by innovation, driving health, wellness & healing.
Dosage Form : Tablet
Grade : Oral
Application : Fillers, Diluents & Binders
Excipient Details : Microlose (Lactose Monohydrate & Microcrystalline Cellulose) is used as a diluent in oral dosage forms such as tablets.
Pharmacopoeia Ref : USP-NF,BP,EP,IP
Technical Specs : Lactose Monohydrate – 40%, Microcrystalline cellulose – 60%
Ingredient(s) : Lactose Monohydrate
Gangwal Healthcare is powered by innovation, driving health, wellness & healing.
Dosage Form : Capsule
Grade : Oral
Application : Fillers, Diluents & Binders
Excipient Details : ProBlend (SMCC) is a co-processed excipient consists of microcrystalline cellulose & colloidal silicon dioxide, used as a diluent & binder in OSDs.
Pharmacopoeia Ref : USP-NF,BP,EP,IP
Technical Specs : NA
Ingredient(s) : Microcrystalline Cellulose Excipients
Gangwal Healthcare is powered by innovation, driving health, wellness & healing.
Dosage Form : Tablet
Grade : Oral
Application : Fillers, Diluents & Binders
Excipient Details : Starlose P40 (Starch & Lactose Monohydrate) is used as a diluent in oral dosage forms such as tablets.
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Nanjing Well Pharmaceutical
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Direct Compression
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Co-Processed Excipients
Chewable & Orodispersible Aids
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Digital Content
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PharmaCompass offers a list of Perindopril Erbumine 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 Perindopril Erbumine manufacturer or Perindopril Erbumine supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Perindopril Erbumine manufacturer or Perindopril Erbumine supplier.
PharmaCompass also assists you with knowing the Perindopril Erbumine API Price utilized in the formulation of products. Perindopril Erbumine API Price is not always fixed or binding as the Perindopril Erbumine Price is obtained through a variety of data sources. The Perindopril Erbumine Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A AKOS015841351 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of AKOS015841351, including repackagers and relabelers. The FDA regulates AKOS015841351 manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. AKOS015841351 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 AKOS015841351 manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A AKOS015841351 supplier is an individual or a company that provides AKOS015841351 active pharmaceutical ingredient (API) or AKOS015841351 finished formulations upon request. The AKOS015841351 suppliers may include AKOS015841351 API manufacturers, exporters, distributors and traders.
click here to find a list of AKOS015841351 suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A AKOS015841351 DMF (Drug Master File) is a document detailing the whole manufacturing process of AKOS015841351 active pharmaceutical ingredient (API) in detail. Different forms of AKOS015841351 DMFs exist exist since differing nations have different regulations, such as AKOS015841351 USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A AKOS015841351 DMF submitted to regulatory agencies in the US is known as a USDMF. AKOS015841351 USDMF includes data on AKOS015841351's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The AKOS015841351 USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of AKOS015841351 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 AKOS015841351 Drug Master File in Japan (AKOS015841351 JDMF) empowers AKOS015841351 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 AKOS015841351 JDMF during the approval evaluation for pharmaceutical products. At the time of AKOS015841351 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 AKOS015841351 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 AKOS015841351 Drug Master File in Korea (AKOS015841351 KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of AKOS015841351. The MFDS reviews the AKOS015841351 KDMF as part of the drug registration process and uses the information provided in the AKOS015841351 KDMF to evaluate the safety and efficacy of the drug.
After submitting a AKOS015841351 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 AKOS015841351 API can apply through the Korea Drug Master File (KDMF).
click here to find a list of AKOS015841351 suppliers with KDMF on PharmaCompass.
A AKOS015841351 CEP of the European Pharmacopoeia monograph is often referred to as a AKOS015841351 Certificate of Suitability (COS). The purpose of a AKOS015841351 CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of AKOS015841351 EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of AKOS015841351 to their clients by showing that a AKOS015841351 CEP has been issued for it. The manufacturer submits a AKOS015841351 CEP (COS) as part of the market authorization procedure, and it takes on the role of a AKOS015841351 CEP holder for the record. Additionally, the data presented in the AKOS015841351 CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the AKOS015841351 DMF.
A AKOS015841351 CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. AKOS015841351 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 AKOS015841351 suppliers with CEP (COS) on PharmaCompass.
A AKOS015841351 written confirmation (AKOS015841351 WC) is an official document issued by a regulatory agency to a AKOS015841351 manufacturer, verifying that the manufacturing facility of a AKOS015841351 active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting AKOS015841351 APIs or AKOS015841351 finished pharmaceutical products to another nation, regulatory agencies frequently require a AKOS015841351 WC (written confirmation) as part of the regulatory process.
click here to find a list of AKOS015841351 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 AKOS015841351 as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for AKOS015841351 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 AKOS015841351 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 AKOS015841351 and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a AKOS015841351 NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of AKOS015841351 suppliers with NDC on PharmaCompass.
AKOS015841351 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 AKOS015841351 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 AKOS015841351 GMP manufacturer or AKOS015841351 GMP API supplier for your needs.
A AKOS015841351 CoA (Certificate of Analysis) is a formal document that attests to AKOS015841351's compliance with AKOS015841351 specifications and serves as a tool for batch-level quality control.
AKOS015841351 CoA mostly includes findings from lab analyses of a specific batch. For each AKOS015841351 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.
AKOS015841351 may be tested according to a variety of international standards, such as European Pharmacopoeia (AKOS015841351 EP), AKOS015841351 JP (Japanese Pharmacopeia) and the US Pharmacopoeia (AKOS015841351 USP).
