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API SUPPLIERS
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USDMF
Chunghwa provides cost-effective APIs & advanced intermediates with complete DMF or COS, ensuring quality & reliable production.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 40868
Submission : 2024-11-28
Status :
Type : II
Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.
GDUFA
DMF Review : Complete
Rev. Date : 2024-02-13
Pay. Date : 2024-01-08
DMF Number : 39129
Submission : 2023-12-31
Status :
Type : II
ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.
GDUFA
DMF Review : Complete
Rev. Date : 2022-10-25
Pay. Date : 2022-09-28
DMF Number : 37269
Submission : 2022-08-29
Status :
Type : II
Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
GDUFA
DMF Review : Complete
Rev. Date : 2023-11-08
Pay. Date : 2023-09-28
DMF Number : 38008
Submission : 2023-03-31
Status :
Type : II
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Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.
Date of Issue : 2022-05-02
Valid Till : 2025-05-01
Written Confirmation Number : WC-0526
Address of the Firm : Unit-V, Plot No.30, Jawaharlal Nehru Pharmacity, Parawada (M), Visakapatnam-531 ...
Metrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.
Date of Issue : 2024-04-03
Valid Till : 2027-01-21
Written Confirmation Number : WC-0493
Address of the Firm : Unit-IV, Plot No: 34B, 40B & 60B, J.N. Pharma City, Thanam (V), Parawada (M), An...
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API/FDF Prices: Book a Demo to explore the features and consider upgrading later
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DOSAGE - TABLET;ORAL - EQ 100MG ACID **Federa...DOSAGE - TABLET;ORAL - EQ 100MG ACID **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 22291
DOSAGE - TABLET;ORAL - EQ 12.5MG ACID
USFDA APPLICATION NUMBER - 22291
DOSAGE - TABLET;ORAL - EQ 25MG ACID
USFDA APPLICATION NUMBER - 22291
DOSAGE - TABLET;ORAL - EQ 50MG ACID
USFDA APPLICATION NUMBER - 22291
DOSAGE - TABLET;ORAL - EQ 75MG ACID
USFDA APPLICATION NUMBER - 22291
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ABOUT THIS PAGE
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PharmaCompass offers a list of Eltrombopag 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 Eltrombopag manufacturer or Eltrombopag supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Eltrombopag manufacturer or Eltrombopag supplier.
PharmaCompass also assists you with knowing the Eltrombopag API Price utilized in the formulation of products. Eltrombopag API Price is not always fixed or binding as the Eltrombopag Price is obtained through a variety of data sources. The Eltrombopag Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A SB19102 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of SB19102, including repackagers and relabelers. The FDA regulates SB19102 manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. SB19102 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 SB19102 manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A SB19102 supplier is an individual or a company that provides SB19102 active pharmaceutical ingredient (API) or SB19102 finished formulations upon request. The SB19102 suppliers may include SB19102 API manufacturers, exporters, distributors and traders.
click here to find a list of SB19102 suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A SB19102 DMF (Drug Master File) is a document detailing the whole manufacturing process of SB19102 active pharmaceutical ingredient (API) in detail. Different forms of SB19102 DMFs exist exist since differing nations have different regulations, such as SB19102 USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A SB19102 DMF submitted to regulatory agencies in the US is known as a USDMF. SB19102 USDMF includes data on SB19102's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The SB19102 USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of SB19102 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 SB19102 Drug Master File in Japan (SB19102 JDMF) empowers SB19102 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 SB19102 JDMF during the approval evaluation for pharmaceutical products. At the time of SB19102 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 SB19102 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 SB19102 Drug Master File in Korea (SB19102 KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of SB19102. The MFDS reviews the SB19102 KDMF as part of the drug registration process and uses the information provided in the SB19102 KDMF to evaluate the safety and efficacy of the drug.
After submitting a SB19102 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 SB19102 API can apply through the Korea Drug Master File (KDMF).
click here to find a list of SB19102 suppliers with KDMF on PharmaCompass.
A SB19102 written confirmation (SB19102 WC) is an official document issued by a regulatory agency to a SB19102 manufacturer, verifying that the manufacturing facility of a SB19102 active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting SB19102 APIs or SB19102 finished pharmaceutical products to another nation, regulatory agencies frequently require a SB19102 WC (written confirmation) as part of the regulatory process.
click here to find a list of SB19102 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 SB19102 as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for SB19102 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 SB19102 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 SB19102 and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a SB19102 NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of SB19102 suppliers with NDC on PharmaCompass.
SB19102 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 SB19102 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 SB19102 GMP manufacturer or SB19102 GMP API supplier for your needs.
A SB19102 CoA (Certificate of Analysis) is a formal document that attests to SB19102's compliance with SB19102 specifications and serves as a tool for batch-level quality control.
SB19102 CoA mostly includes findings from lab analyses of a specific batch. For each SB19102 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.
SB19102 may be tested according to a variety of international standards, such as European Pharmacopoeia (SB19102 EP), SB19102 JP (Japanese Pharmacopeia) and the US Pharmacopoeia (SB19102 USP).
