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
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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/FDF Prices: Book a Demo to explore the features and consider upgrading later
API Imports and Exports
Drugs in Development
Lead Product(s) : Amcenestrant,Palbociclib
Therapeutic Area : Oncology
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : The pivotal study (AMEERA-3) of amcenestrant versus physician’s choice in locally advanced or metastatic estrogen receptor-positive (ER+) breast cancer is fully recruited; readout expected in H2 2021.
Product Name : SAR439859
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
May 19, 2021
Lead Product(s) : Amcenestrant,Palbociclib
Therapeutic Area : Oncology
Highest Development Status : Phase I/ Phase II
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Company going to present clinical data on its oncology portfolio including data on its Phase 1/2 study of SAR439859, an oral selective estrogen receptor degrader (SERD), in estrogen receptor-positive (ER+)/HER2- metastatic breast cancer.
Product Name : SAR439859
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
May 13, 2020
Lead Product(s) : Palbociclib,Fulvestrant
Therapeutic Area : Oncology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Dr. Reddy’s Launches In-House Palbociclib (PRIMCYV®) To Widen Access to High-Quality Breast Can...
Details : PRIMCYV® is a targeted therapy containing the active constituent palbociclib, a first-in-class CDK 4/6 inhibitor indicated in combination with an aromatase inhibitor for the first-line treatment of adult patients with HR+, HER2- metastatic breast cancer...
Product Name : Primcyv
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
January 13, 2023
Lead Product(s) : Fulvestrant,Palbociclib
Therapeutic Area : Oncology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Dr. Reddy’s Fulvestrant Injection, 250 mg/5 mL (50 mg/mL) per Single-dose Syringe is available in a carton containing two 5 mL single-dose prefilled syringes.
Product Name : Fulvestrant-Generic
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
July 09, 2020
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]INTERMEDIATE SUPPLIERS
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FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]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
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Nanjing Well Pharmaceutical
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]ACG Worldwide
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Anhui Sunhere Pharmaceutical Excipients Co.,Ltd
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FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Gangwal Chemicals
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Ideal Cures
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Ingredion Pharma Solutions
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FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Nitika Pharmaceutical Specialities
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Pharmatrans-Sanaq
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Pluviaendo
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FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Roquette
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Seppic
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Shanghai Shenmei Pharmaceutical Technology Co., Ltd
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Sigachi Industries
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Silverline Chemicals
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Fillers, Diluents & Binders
Thickeners and Stabilizers
Disintegrants & Superdisintegrants
Direct Compression
Granulation
Lubricants & Glidants
Coating Systems & Additives
Co-Processed Excipients
Empty Capsules
Film Formers & Plasticizers
Emulsifying Agents
Controlled & Modified Release
Chewable & Orodispersible Aids
Taste Masking
Topical
Rheology Modifiers
Parenteral
Solubilizers
Coloring Agents
API Stability Enhancers
Digital Content
DATA COMPILATION #PharmaFlow
NEWS #PharmaBuzz
Global Sales Information
US Medicaid Prescriptions
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US Patents
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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 PD 332991, PD 0332991, 827022-32-2 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of PD 332991, PD 0332991, 827022-32-2, including repackagers and relabelers. The FDA regulates PD 332991, PD 0332991, 827022-32-2 manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. PD 332991, PD 0332991, 827022-32-2 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 PD 332991, PD 0332991, 827022-32-2 manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A PD 332991, PD 0332991, 827022-32-2 supplier is an individual or a company that provides PD 332991, PD 0332991, 827022-32-2 active pharmaceutical ingredient (API) or PD 332991, PD 0332991, 827022-32-2 finished formulations upon request. The PD 332991, PD 0332991, 827022-32-2 suppliers may include PD 332991, PD 0332991, 827022-32-2 API manufacturers, exporters, distributors and traders.
click here to find a list of PD 332991, PD 0332991, 827022-32-2 suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A PD 332991, PD 0332991, 827022-32-2 DMF (Drug Master File) is a document detailing the whole manufacturing process of PD 332991, PD 0332991, 827022-32-2 active pharmaceutical ingredient (API) in detail. Different forms of PD 332991, PD 0332991, 827022-32-2 DMFs exist exist since differing nations have different regulations, such as PD 332991, PD 0332991, 827022-32-2 USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A PD 332991, PD 0332991, 827022-32-2 DMF submitted to regulatory agencies in the US is known as a USDMF. PD 332991, PD 0332991, 827022-32-2 USDMF includes data on PD 332991, PD 0332991, 827022-32-2's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The PD 332991, PD 0332991, 827022-32-2 USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of PD 332991, PD 0332991, 827022-32-2 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 PD 332991, PD 0332991, 827022-32-2 Drug Master File in Korea (PD 332991, PD 0332991, 827022-32-2 KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of PD 332991, PD 0332991, 827022-32-2. The MFDS reviews the PD 332991, PD 0332991, 827022-32-2 KDMF as part of the drug registration process and uses the information provided in the PD 332991, PD 0332991, 827022-32-2 KDMF to evaluate the safety and efficacy of the drug.
After submitting a PD 332991, PD 0332991, 827022-32-2 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 PD 332991, PD 0332991, 827022-32-2 API can apply through the Korea Drug Master File (KDMF).
click here to find a list of PD 332991, PD 0332991, 827022-32-2 suppliers with KDMF on PharmaCompass.
A PD 332991, PD 0332991, 827022-32-2 written confirmation (PD 332991, PD 0332991, 827022-32-2 WC) is an official document issued by a regulatory agency to a PD 332991, PD 0332991, 827022-32-2 manufacturer, verifying that the manufacturing facility of a PD 332991, PD 0332991, 827022-32-2 active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting PD 332991, PD 0332991, 827022-32-2 APIs or PD 332991, PD 0332991, 827022-32-2 finished pharmaceutical products to another nation, regulatory agencies frequently require a PD 332991, PD 0332991, 827022-32-2 WC (written confirmation) as part of the regulatory process.
click here to find a list of PD 332991, PD 0332991, 827022-32-2 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 PD 332991, PD 0332991, 827022-32-2 as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for PD 332991, PD 0332991, 827022-32-2 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 PD 332991, PD 0332991, 827022-32-2 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 PD 332991, PD 0332991, 827022-32-2 and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a PD 332991, PD 0332991, 827022-32-2 NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of PD 332991, PD 0332991, 827022-32-2 suppliers with NDC on PharmaCompass.
PD 332991, PD 0332991, 827022-32-2 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 PD 332991, PD 0332991, 827022-32-2 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 PD 332991, PD 0332991, 827022-32-2 GMP manufacturer or PD 332991, PD 0332991, 827022-32-2 GMP API supplier for your needs.
A PD 332991, PD 0332991, 827022-32-2 CoA (Certificate of Analysis) is a formal document that attests to PD 332991, PD 0332991, 827022-32-2's compliance with PD 332991, PD 0332991, 827022-32-2 specifications and serves as a tool for batch-level quality control.
PD 332991, PD 0332991, 827022-32-2 CoA mostly includes findings from lab analyses of a specific batch. For each PD 332991, PD 0332991, 827022-32-2 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.
PD 332991, PD 0332991, 827022-32-2 may be tested according to a variety of international standards, such as European Pharmacopoeia (PD 332991, PD 0332991, 827022-32-2 EP), PD 332991, PD 0332991, 827022-32-2 JP (Japanese Pharmacopeia) and the US Pharmacopoeia (PD 332991, PD 0332991, 827022-32-2 USP).
