Synopsis
0
CEP/COS
0
JDMF
0
KDMF
0
VMF
0
EDQM
0
USP
0
JP
0
Others
0
Australia
0
Listed Dossiers
DRUG PRODUCT COMPOSITIONS
0
FDF
0
Data Compilation #PharmaFlow
0
Stock Recap #PipelineProspector
0
Weekly News Recap #Phispers
API SUPPLIERS
With Virupaksha, you get a quality product with on-time delivery.
Click Us!
NDC
ChemExpress delivers end-to-end CRO & CDMO solutions for small molecules, biologics & new modalities with ICH-grade quality.
Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
Metrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.
China’s top API & intermediate manufacturer, delivering advanced CMO/CDMO solutions to 60+ countries, empowering global health progress
Omgene: R&D-based biopharmaceutical company with GMP facilities, focused on innovation and high-quality, affordable medicines.
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
Honour is a leading global CDMO and specialty chemicals manufacturer with seven world-class sites delivering quality-driven solutions.
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]
USDMF
With Virupaksha, you get a quality product with on-time delivery.
GDUFA
DMF Review : Complete
Rev. Date : 2019-11-05
Pay. Date : 2019-10-18
DMF Number : 33275
Submission : 2018-10-17
Status :
Type : II
Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 33218
Submission : 2018-10-01
Status :
Type : II
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
GDUFA
DMF Review : Complete
Rev. Date : 2020-08-04
Pay. Date : 2020-06-04
DMF Number : 34920
Submission : 2020-06-30
Status :
Type : II
Honour is a leading global CDMO and specialty chemicals manufacturer with seven world-class sites delivering quality-driven solutions.
GDUFA
DMF Review : Complete
Rev. Date : 2019-02-26
Pay. Date : 2019-01-28
DMF Number : 33060
Submission : 2019-01-11
Status :
Type : II
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]EU WC
With Virupaksha, you get a quality product with on-time delivery.
Date of Issue : 2025-10-01
Valid Till : 2028-09-30
Written Confirmation Number : WC-0191
Address of the Firm : Sy. No. 10, Gaddapotharam (V), Jinnaram (M), Sangareddy District 502319, Telanga...
China’s top API & intermediate manufacturer, delivering advanced CMO/CDMO solutions to 60+ countries, empowering global health progress
Date of Issue : 2024-08-28
Valid Till : 2027-08-27
Written Confirmation Number : SD240048
Address of the Firm : Economic Development Zone, Pingyuan County, Dezhou City, Shandong
Honour is a leading global CDMO and specialty chemicals manufacturer with seven world-class sites delivering quality-driven solutions.
Date of Issue : 2025-09-03
Valid Till : 2028-09-02
Written Confirmation Number : WC-0362
Address of the Firm : Plot No:4, Hetero Infrastructure SEZ Ltd.,Narasapuram, Visakhapatnam-531081, And...
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
With Virupaksha, you get a quality product with on-time delivery.
About the Company : Virupaksha Organics, founded in 2003, is a leading manufacturer of APIs and intermediates. Its FDA-audited, ISO-certified facilities in Kazipally and Pashamylaram produce high-qual...
ChemExpress delivers end-to-end CRO & CDMO solutions for small molecules, biologics & new modalities with ICH-grade quality.
About the Company : Founded in 2006, ChemExpress provides CRO and CDMO services to pharmaceutical and biotech companies. The company supports small molecules, biologics, and new modalities such as ADC...
Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
About the Company : Biophore, founded in 2007, develops and manufactures niche and complex pharmaceutical products. With USFDA- and EU-approved API facilities, a dedicated intermediates site and an R&...
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
About the Company : LGM Pharma is a global leader in sourcing APIs, including hard-to-find drug substances, for pharmaceutical and biotech industries. LGM also operates as a full-service drug product ...
Metrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.
About the Company : Established in 2004, Metrochem API is one of the fastest-growing APIs, pellets & intermediates manufacturers. It has 6 dedicated manufacturing facilities for its 3 core product gro...
China’s top API & intermediate manufacturer, delivering advanced CMO/CDMO solutions to 60+ countries, empowering global health progress
About the Company : Shandong Chenghui Shuangda Pharmaceutical Co., Ltd. specializes in API and advanced intermediate R&D and manufacturing, delivering comprehensive CDMO/CRO/OEM services and Finished ...
Omgene: R&D-based biopharmaceutical company with GMP facilities, focused on innovation and high-quality, affordable medicines.
About the Company : Omgene Life Sciences Pvt. Ltd. is an R&D-driven biopharmaceutical company specializing in biopharmaceuticals, peptides, semi-synthetic, and synthetic actives. As a vertically integ...
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
About the Company : Founded in 1935, TAPI Technology & API Services has a long legacy of advancing health through innovation. Today, we offer one of the industry’s most comprehensive API portfolios ...
Honour is a leading global CDMO and specialty chemicals manufacturer with seven world-class sites delivering quality-driven solutions.
About the Company : Honour is a leading global CDMO and trusted manufacturer of specialty chemicals and ingredients, with seven world-class facilities meeting global safety and quality standards. Thro...
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Drugs in Development
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]INTERMEDIATE SUPPLIERS
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]FDF Dossiers
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]FDA Orange Book
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Europe
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Canada
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]South Africa
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Related Excipient Companies
Nanjing Well Pharmaceutical
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]CD Formulation
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Topical
Solubilizers
Thickeners and Stabilizers
Film Formers & Plasticizers
Emulsifying Agents
Controlled & Modified Release
Parenteral
Coating Systems & Additives
Digital Content
NEWS #PharmaBuzz
Global Sales Information
US Medicaid Prescriptions
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Market Place
ABOUT THIS PAGE
73
PharmaCompass offers a list of Crisaborole 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 Crisaborole manufacturer or Crisaborole supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Crisaborole manufacturer or Crisaborole supplier.
A Crisaborole manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Crisaborole, including repackagers and relabelers. The FDA regulates Crisaborole manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Crisaborole 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 Crisaborole manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Crisaborole supplier is an individual or a company that provides Crisaborole active pharmaceutical ingredient (API) or Crisaborole finished formulations upon request. The Crisaborole suppliers may include Crisaborole API manufacturers, exporters, distributors and traders.
click here to find a list of Crisaborole suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Crisaborole DMF (Drug Master File) is a document detailing the whole manufacturing process of Crisaborole active pharmaceutical ingredient (API) in detail. Different forms of Crisaborole DMFs exist exist since differing nations have different regulations, such as Crisaborole USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Crisaborole DMF submitted to regulatory agencies in the US is known as a USDMF. Crisaborole USDMF includes data on Crisaborole's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Crisaborole USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Crisaborole suppliers with USDMF on PharmaCompass.
A Crisaborole written confirmation (Crisaborole WC) is an official document issued by a regulatory agency to a Crisaborole manufacturer, verifying that the manufacturing facility of a Crisaborole active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Crisaborole APIs or Crisaborole finished pharmaceutical products to another nation, regulatory agencies frequently require a Crisaborole WC (written confirmation) as part of the regulatory process.
click here to find a list of Crisaborole 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 Crisaborole as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Crisaborole 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 Crisaborole 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 Crisaborole and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Crisaborole NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Crisaborole suppliers with NDC on PharmaCompass.
Crisaborole 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 Crisaborole GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Crisaborole GMP manufacturer or Crisaborole GMP API supplier for your needs.
A Crisaborole CoA (Certificate of Analysis) is a formal document that attests to Crisaborole's compliance with Crisaborole specifications and serves as a tool for batch-level quality control.
Crisaborole CoA mostly includes findings from lab analyses of a specific batch. For each Crisaborole 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.
Crisaborole may be tested according to a variety of international standards, such as European Pharmacopoeia (Crisaborole EP), Crisaborole JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Crisaborole USP).
