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List of Japan Drug Master File (JDMF) for Leuprolide Acetate Active Pharmaceutical Ingredient submitted to the Review Authority in Japan (PMDA) and listed on PharmaCompass.com

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  • POWDER;INTRAMUSCULAR - 11.25MG
  • POWDER;INTRAMUSCULAR - 15MG
  • POWDER;INTRAMUSCULAR - 3.75MG,7.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
  • POWDER;INTRAMUSCULAR - 30MG
  • POWDER;INTRAMUSCULAR - 45MG
  • POWDER;INTRAMUSCULAR - 7.5MG
  • POWDER;INTRAMUSCULAR - 7.5MG,7.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
  • INJECTABLE, TABLET;INTRAMUSCULAR, ORAL - 11.25MG/VIAL,N/A;N/A,5MG
  • INJECTABLE, TABLET;INTRAMUSCULAR, ORAL - 3.75MG/VIAL,N/A;N/A,5MG

Looking for 74381-53-6 / Leuprolide Acetate API manufacturers, exporters & distributors?

Leuprolide Acetate manufacturers, exporters & distributors 1

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PharmaCompass offers a list of Leuprolide Acetate 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 Leuprolide Acetate manufacturer or Leuprolide Acetate supplier for your needs.

Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Leuprolide Acetate manufacturer or Leuprolide Acetate supplier.

PharmaCompass also assists you with knowing the Leuprolide Acetate API Price utilized in the formulation of products. Leuprolide Acetate API Price is not always fixed or binding as the Leuprolide Acetate Price is obtained through a variety of data sources. The Leuprolide Acetate Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.

API | Excipient name

Leuprolide Acetate

Synonyms

74381-53-6, Leuprorelin acetate;h-pyr-his-trp-ser-tyr-d-leu-leu-arg-pro-nhet.ch3co2h, Lupron (tn), Mfcd00072080, Fensolvi (tn), Eligard (tn)

Cas Number

74381-53-6

Leuprolide Acetate Manufacturers

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

Leuprolide Acetate Suppliers

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

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

Leuprolide Acetate JDMF

The Pharmaceuticals and Medical Devices Agency (PMDA) established the Japan Drug Master File (JDMF), also known as the Master File (MF), to permit Japanese and foreign manufacturers of drug substances, intermediates, excipients, raw materials, and packaging materials (‘Products’) to voluntarily register confidential information about the production and management of their products in Japan.

The Leuprolide Acetate Drug Master File in Japan (Leuprolide Acetate JDMF) empowers Leuprolide Acetate API manufacturers to present comprehensive information (e.g., production methods, data, etc.) to the review authority, i.e., PMDA (Pharmaceuticals & Medical Devices Agency).

PMDA reviews the Leuprolide Acetate JDMF during the approval evaluation for pharmaceutical products. At the time of Leuprolide Acetate JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.

click here to find a list of Leuprolide Acetate suppliers with JDMF on PharmaCompass.

Leuprolide Acetate Manufacturers | Traders | Suppliers

Leuprolide Acetate Manufacturers, Traders, Suppliers 1
64

We have 5 companies offering Leuprolide Acetate

Get in contact with the supplier of your choice:

  1. Aspen API
  2. Bachem AG
  3. BCN Peptides
  4. Chemi SpA
  5. PolyPeptide Group
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.
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