Shanghai Minbiotech Sirolimus Shanghai Minbiotech Sirolimus

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

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  • TABLET;ORAL - 0.5MG
  • TABLET;ORAL - 1MG
  • TABLET;ORAL - 2MG
  • TABLET;ORAL - 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Looking for 53123-88-9 / Sirolimus API manufacturers, exporters & distributors?

Sirolimus manufacturers, exporters & distributors 1

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

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

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

API | Excipient name

Sirolimus

Synonyms

(-)-rapamycin, 53123-88-9, Ay 22989, Ay-22989, I 2190a, I-2190a

Cas Number

53123-88-9

Unique Ingredient Identifier (UNII)

W36ZG6FT64

About Sirolimus

A macrolide compound obtained from Streptomyces hygroscopicus that acts by selectively blocking the transcriptional activation of cytokines thereby inhibiting cytokine production. It is bioactive only when bound to IMMUNOPHILINS. Sirolimus is a potent immunosuppressant and possesses both antifungal and antineoplastic properties.

Sirolimus Manufacturers

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

Sirolimus Suppliers

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

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

Sirolimus 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 Sirolimus Drug Master File in Japan (Sirolimus JDMF) empowers Sirolimus 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 Sirolimus JDMF during the approval evaluation for pharmaceutical products. At the time of Sirolimus 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 Sirolimus suppliers with JDMF on PharmaCompass.

Sirolimus Manufacturers | Traders | Suppliers

Sirolimus Manufacturers, Traders, Suppliers 1
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We have 3 companies offering Sirolimus

Get in contact with the supplier of your choice:

  1. Alkermes Plc
  2. Chunghwa Chemical Synthesis & Biotech
  3. Concord Biotech
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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