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Hubei Gedian Humanwell Pharmaceutical Testosterone Undecanoate Hubei Gedian Humanwell Pharmaceutical Testosterone Undecanoate

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List of Drug Master Files (KDMF) for Testosterone Undecanoate Active Pharmaceutical Ingredient (API) submitted to the Review Authority in Korea.

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01 Aspen Oss B.V. (1)

02 Symbiotec Pharmalab Pvt. Ltd. (1)

03 Steroid SpA (1)

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01 Chong Kun Dang Co., Ltd. (1)

02 Lucepharm Co., Ltd. (1)

03 Sinex Co., Ltd. (1)

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01 Testosterone Undecanoate (3)

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01 India (1)

02 Italy (1)

03 Netherlands (1)

Sinex Co., Ltd.
2024-01-03
20240103-210-J-1588
Aspen Oss B.V.
Netherlands
Veersemeer 4, 5347 JN Oss...
Lucepharm Co., Ltd.
2023-06-12
20230612-210-J-1510
Symbiotec Pharmalab Pvt. ...
India
Plot No. 5, 6, 7 & 8, Spe...
URL Supplier Web Content
Chong Kun Dang Co., Ltd.
2022-04-19
20220419-210-J-1271
Steroid SpA
Italy
Viale Spagna, 156 - 20093...
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Looking for 5949-44-0 / Testosterone Undecanoate API manufacturers, exporters & distributors?

Testosterone Undecanoate manufacturers, exporters & distributors 1

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PharmaCompass offers a list of Testosterone Undecanoate 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 Testosterone Undecanoate manufacturer or Testosterone Undecanoate supplier for your needs.

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

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

API | Excipient name

Testosterone Undecanoate

Synonyms

5949-44-0, Andriol, Testosterone undecylate, Nebido, Testosterone (undecanoate), Aveed

Cas Number

5949-44-0

Unique Ingredient Identifier (UNII)

H16A5VCT9C

About Testosterone Undecanoate

Testosterone Undecanoate is the undecanoate ester form of the androgen testosterone, with gonadotropin-secretory inhibiting and hormone replacement activity. As testosterone inhibits the secretion of gonadotropins from the pituitary gland, administration of testosterone decreases the secretion of luteinizing hormone (LH). By inhibiting LH secretion, the growth of Leydig cells, which are normally stimulated by LH to produce testosterone, may be suppressed. In addition, this agent promotes the maintenance of male sex characteristics and can be used for testosterone replacement in hypogonadal males.

Testosterone Undecanoate Manufacturers

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

Testosterone Undecanoate Suppliers

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

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

Testosterone Undecanoate KDMF

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

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

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

click here to find a list of Testosterone Undecanoate suppliers with KDMF on PharmaCompass.

Testosterone Undecanoate Manufacturers | Traders | Suppliers

Testosterone Undecanoate Manufacturers, Traders, Suppliers 1
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We have 3 companies offering Testosterone Undecanoate

Get in contact with the supplier of your choice:

  1. Aspen API
  2. Symbiotec Pharmalab
  3. Steroid SpA
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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