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PharmaCompass

01

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothTAPI offers customized CDMO Solutions for API development and manufacturing services.

GDUFA

DMF Review : Complete

Rev. Date : 2020-08-18

Pay. Date : 2020-08-12

DMF Number : 21182

Submission : 2007-12-21

Status : Active

Type : II

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Letrozole Manufacturers

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

Letrozole Suppliers

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

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

Letrozole USDMF

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

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

click here to find a list of Letrozole 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.