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List of Korea Drug Master Files (KDMF) for Leuprolide Acetate Active Pharmaceutical Ingredient submitted to the Review Authority in Korea and listed on PharmaCompass.com

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Flag Switzerland
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Hiple Co., Ltd.
2022-12-07
20221207-210-J-1398
Bachem AG
Switzerland
Hauptstrasse 144, 4416 Bu...
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Anyzen Co., Ltd.
2018-08-29
20180829-210-J-257
Anyzen Co., Ltd.
South Korea
Test production building ...
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LG Chemical Co., Ltd.
2023-02-25
20230225-210-J-1451
BCN PEPTIDES, S.A.
Spain
Pol. Ind. Els Vinyets. El...
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Seil Pharmaceutical Co., Ltd.
2020-06-25
20200625-210-J-661
Chinese Peptide Company
China
No. 69, 12 Street, Econom...
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BC World Pharmaceutical Co., Ltd.
2017-12-08
20170725-210-J-1(1)
PolyPeptide Laboratories ...
India
Plot No K28, Additional M...
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Daewoong Pharmaceutical Co., Ltd.
2019-04-15
20170725-210-J-1(A)
PolyPeptide Laboratories ...
India
Plot No K28, Additional M...
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Peptron Co., Ltd.
2017-07-25
20170725-210-J-1
PolyPeptide Laboratories ...
India
Plot No K28, Additional M...
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Takeda Pharmaceutical Korea Co., Ltd.
2022-10-26
20221026-210-J-1393
Takeda Pharmaceutical Com...
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Hikari Plant: 4720, Taked...
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Naivek Co., Ltd.
2022-06-10
20220610-210-J-1313
Naivek Co., Ltd.
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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  • POWDER;INTRAMUSCULAR - 3.75MG,7.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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  • POWDER;INTRAMUSCULAR - 7.5MG,7.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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

34

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 KDMF

In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.

Pharmaceutical companies submit a Leuprolide Acetate Drug Master File in Korea (Leuprolide Acetate KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Leuprolide Acetate. The MFDS reviews the Leuprolide Acetate KDMF as part of the drug registration process and uses the information provided in the Leuprolide Acetate KDMF to evaluate the safety and efficacy of the drug.

After submitting a Leuprolide Acetate 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 Leuprolide Acetate API can apply through the Korea Drug Master File (KDMF).

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

Leuprolide Acetate Manufacturers | Traders | Suppliers

Leuprolide Acetate Manufacturers, Traders, Suppliers 1
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We have 6 companies offering Leuprolide Acetate

Get in contact with the supplier of your choice:

  1. Bachem AG
  2. Anygen
  3. BCN Peptides
  4. Chinese Peptide Company
  5. PolyPeptide Group
  6. Takeda Pharmaceutical
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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