Synopsis
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CEP/COS
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JDMF
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VMF
DRUG PRODUCT COMPOSITIONS
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Stock Recap #PipelineProspector
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Weekly News Recap #Phispers
API SUPPLIERS
Polpharma is a Polish CDMO of APIs and a significant European API producer, delivering products to companies worldwide.
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DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
NDC
BR
Gonane has API manufacturing expertise in new-age Corticosteroids, Hormones and other pharma raw materials.
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.
Egis is a Hungarian generic pharma company with 110 years history. Our activities incorporate all areas of the pharma value chain.
Faran Shimi: Leading producer of high-quality APIs & alkaloid opiates, serving major pharmaceutical companies across the Middle East.
Aarti Pharmalabs is a partner of choice for APIs & Intermediates and the largest Indian manufacturer of Xanthine Derivatives.
Porton Pharma Solutions: Value creation via innovation & discovery through technical platforms.
Chunghwa provides cost-effective APIs & advanced intermediates with complete DMF or COS, ensuring quality & reliable production.
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USDMF
Polpharma is a Polish CDMO of APIs and a significant European API producer, delivering products to companies worldwide.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 39559
Submission : 2024-04-04
Status :
Type : II
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
GDUFA
DMF Review : Complete
Rev. Date : 2018-07-16
Pay. Date : 2018-06-15
DMF Number : 32646
Submission : 2018-03-28
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 : 2019-01-27
Pay. Date : 2018-08-06
DMF Number : 32867
Submission : 2018-08-03
Status :
Type : II
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 : 37586
Submission : 2022-11-01
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 : 2018-12-03
Pay. Date : 2018-10-18
DMF Number : 33006
Submission : 2018-10-11
Status :
Type : II
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API Imports and Exports
Drugs in Development
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SPI Pharma
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DKSH is your trusted partner for companies looking to grow their business in Asia & beyond.
Dosage Form : Injectable / Parenteral
Grade : Parenteral, Oral
DKSH is your trusted partner for companies looking to grow their business in Asia & beyond.
Dosage Form : Injectable / Parenteral
Grade : Parenteral, Oral
DKSH is your trusted partner for companies looking to grow their business in Asia & beyond.
Dosage Form : Tablet
Grade : Oral
Application : Emulsifying Agents
Excipient Details : HDK N20 Pharma is used as a pharmaceutical emulsifying agent in tablets, capsules, syrups, and solutions.
DKSH is your trusted partner for companies looking to grow their business in Asia & beyond.
Dosage Form : Injectable / Parenteral
Grade : Parenteral, Oral
DKSH is your trusted partner for companies looking to grow their business in Asia & beyond.
Dosage Form : Injectable / Parenteral
Grade : Parenteral, Oral
DKSH is your trusted partner for companies looking to grow their business in Asia & beyond.
Dosage Form : Tablet
Grade : Oral
Brand Name : Titanium dioxide PRETIOX ...
Application : Coating Systems & Additives
Excipient Details : Titanium dioxide Pretiox AV01FG is used as a coloring and coating agent in oral solid dosage forms such as capsules, tablets, granules, and pellets.
Pharmacopoeia Ref : Fami-QS, Kosher, Halal, OHSAS ...
Technical Specs : Ti 59.95% and O 40.05%
Ingredient(s) : Titanium Dioxide
DKSH is your trusted partner for companies looking to grow their business in Asia & beyond.
Dosage Form : Tablet
Grade : Oral
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Faran Shimi Pharmaceutical
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Thickeners and Stabilizers
Disintegrants & Superdisintegrants
Direct Compression
Lubricants & Glidants
Granulation
Empty Capsules
Coating Systems & Additives
Co-Processed Excipients
Film Formers & Plasticizers
Emulsifying Agents
Taste Masking
Topical
Controlled & Modified Release
Solubilizers
Coloring Agents
Chewable & Orodispersible Aids
Parenteral
API Stability Enhancers
Rheology Modifiers
Digital Content
DATA COMPILATION #PharmaFlow
NEWS #PharmaBuzz
Global Sales Information
US Medicaid Prescriptions
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REF. STANDARDS & IMPURITIES
ABOUT THIS PAGE
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PharmaCompass offers a list of Palbociclib 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 Palbociclib manufacturer or Palbociclib supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Palbociclib manufacturer or Palbociclib supplier.
PharmaCompass also assists you with knowing the Palbociclib API Price utilized in the formulation of products. Palbociclib API Price is not always fixed or binding as the Palbociclib Price is obtained through a variety of data sources. The Palbociclib Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Palbociclib manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Palbociclib, including repackagers and relabelers. The FDA regulates Palbociclib manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Palbociclib 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 Palbociclib manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Palbociclib supplier is an individual or a company that provides Palbociclib active pharmaceutical ingredient (API) or Palbociclib finished formulations upon request. The Palbociclib suppliers may include Palbociclib API manufacturers, exporters, distributors and traders.
click here to find a list of Palbociclib suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Palbociclib DMF (Drug Master File) is a document detailing the whole manufacturing process of Palbociclib active pharmaceutical ingredient (API) in detail. Different forms of Palbociclib DMFs exist exist since differing nations have different regulations, such as Palbociclib USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Palbociclib DMF submitted to regulatory agencies in the US is known as a USDMF. Palbociclib USDMF includes data on Palbociclib's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Palbociclib USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Palbociclib 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 Palbociclib Drug Master File in Korea (Palbociclib KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Palbociclib. The MFDS reviews the Palbociclib KDMF as part of the drug registration process and uses the information provided in the Palbociclib KDMF to evaluate the safety and efficacy of the drug.
After submitting a Palbociclib 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 Palbociclib API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Palbociclib suppliers with KDMF on PharmaCompass.
A Palbociclib written confirmation (Palbociclib WC) is an official document issued by a regulatory agency to a Palbociclib manufacturer, verifying that the manufacturing facility of a Palbociclib active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Palbociclib APIs or Palbociclib finished pharmaceutical products to another nation, regulatory agencies frequently require a Palbociclib WC (written confirmation) as part of the regulatory process.
click here to find a list of Palbociclib 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 Palbociclib as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Palbociclib 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 Palbociclib 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 Palbociclib and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Palbociclib NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Palbociclib suppliers with NDC on PharmaCompass.
Palbociclib 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 Palbociclib 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 Palbociclib GMP manufacturer or Palbociclib GMP API supplier for your needs.
A Palbociclib CoA (Certificate of Analysis) is a formal document that attests to Palbociclib's compliance with Palbociclib specifications and serves as a tool for batch-level quality control.
Palbociclib CoA mostly includes findings from lab analyses of a specific batch. For each Palbociclib 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.
Palbociclib may be tested according to a variety of international standards, such as European Pharmacopoeia (Palbociclib EP), Palbociclib JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Palbociclib USP).
