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01 1Polpharma

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03 1Biophore India Pharmaceuticals Pvt Ltd

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PharmaCompass

01

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothPolpharma 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 : Active

Type : II

Polpharma CB

02

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothDRL 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 : Active

Type : II

Dr Reddy Company Banner

03

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothBiophore 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 : Active

Type : II

Biophore

04

OPRD USA
Not Confirmed
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothChunghwa 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 : Active

Type : II

CCSB Company Banner

05

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothTAPI, 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 : Active

Type : II

TAPI Company Banner

07

OPRD USA
Not Confirmed

Looking for 571190-30-2 / Palbociclib API manufacturers, exporters & distributors?

Palbociclib manufacturers, exporters & distributors 1

76

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.

API | Excipient name

Palbociclib

Synonyms

571190-30-2, Pd-0332991, Ibrance, Pd0332991, Pd 0332991, Palbociclib free base

Cas Number

571190-30-2

Unique Ingredient Identifier (UNII)

G9ZF61LE7G

About Palbociclib

Palbociclib is an orally available cyclin-dependent kinase (CDK) inhibitor with potential antineoplastic activity. Palbociclib selectively inhibits cyclin-dependent kinase 4 (CDK4) and 6 (CDK6), thereby inhibiting retinoblastoma (Rb) protein phosphorylation early in the G1 phase leading to cell cycle arrest. This suppresses DNA replication and decreases tumor cell proliferation. CDK4 and 6 are serine/threonine kinases that are upregulated in many tumor cell types and play a key role in the regulation of cell cycle progression.

Palbociclib Manufacturers

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.

Palbociclib Suppliers

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.

Palbociclib USDMF

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.

Inform the supplier about your product requirements, specifying if you need a product with particular monograph like EP (Ph. Eur.), USP, JP, BP, or any other quality. In addition, clarify whether you need hydrochloride (HCl), anhydricum, base, micronisatum or a specific level of purity. To find reputable suppliers, utilize the filters and select those certified by GMP, FDA, or any other certification as per your requirement.
For your convenience, we have listed synonyms and CAS numbers to help you find the best supplier. The use of synonyms and CAS numbers can be helpful in identifying potential suppliers, but it is crucial to note that they might not always indicate the exact same product. It is important to confirm the product details with the supplier before making a purchase to ensure that it meets your requirements.