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01 1Olon S.p.A

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Valary Lab Private Ltd

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USDMF

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Valary Lab Private Ltd

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GDUFA

DMF Review : Complete

Rev. Date : 2024-06-26

Pay. Date : 2024-06-17

DMF Number : 39814

Submission : 2024-04-15

Status : Active

Type : II

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Pralsetinib Manufacturers

A Pralsetinib manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Pralsetinib, including repackagers and relabelers. The FDA regulates Pralsetinib manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Pralsetinib 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 Pralsetinib manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

Pralsetinib Suppliers

A Pralsetinib supplier is an individual or a company that provides Pralsetinib active pharmaceutical ingredient (API) or Pralsetinib finished formulations upon request. The Pralsetinib suppliers may include Pralsetinib API manufacturers, exporters, distributors and traders.

click here to find a list of Pralsetinib suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

Pralsetinib USDMF

A Pralsetinib DMF (Drug Master File) is a document detailing the whole manufacturing process of Pralsetinib active pharmaceutical ingredient (API) in detail. Different forms of Pralsetinib DMFs exist exist since differing nations have different regulations, such as Pralsetinib USDMF, ASMF (EDMF), JDMF, CDMF, etc.

A Pralsetinib DMF submitted to regulatory agencies in the US is known as a USDMF. Pralsetinib USDMF includes data on Pralsetinib's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Pralsetinib USDMF is kept confidential to protect the manufacturer’s intellectual property.

click here to find a list of Pralsetinib suppliers with USDMF on PharmaCompass.

Pralsetinib Manufacturers | Traders | Suppliers

Pralsetinib Manufacturers, Traders, Suppliers 1
64

We have 1 companies offering Pralsetinib

Get in contact with the supplier of your choice:

  1. Olon S.p.A
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.