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  • TABLET;ORAL - 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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

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

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

click here to find a list of Sirolimus suppliers with USDMF 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 KDMF

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

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

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

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

Sirolimus WC

A Sirolimus written confirmation (Sirolimus WC) is an official document issued by a regulatory agency to a Sirolimus manufacturer, verifying that the manufacturing facility of a Sirolimus active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Sirolimus APIs or Sirolimus finished pharmaceutical products to another nation, regulatory agencies frequently require a Sirolimus WC (written confirmation) as part of the regulatory process.

click here to find a list of Sirolimus suppliers with Written Confirmation (WC) on PharmaCompass.

Sirolimus NDC

National Drug Code is a comprehensive database maintained by the FDA that contains information on all drugs marketed in the US. This directory includes information about finished drug products, unfinished drug products, and compounded drug products, including those containing Sirolimus as an active pharmaceutical ingredient (API).

Finished drug products

The FDA updates the NDC directory daily. The NDC numbers for Sirolimus API and other APIs are published in this directory by the FDA.

Unfinished drugs

The NDC unfinished drugs database includes product listing information submitted for all unfinished drugs, such as active pharmaceutical ingredients (APIs), drugs intended for further processing and bulk drug substances for compounding.

Pharmaceutical companies that manufacture Sirolimus as an active pharmaceutical ingredient (API) must furnish the FDA with an updated record of all drugs that they produce, prepare, propagate, compound, or process for commercial distribution in the US at their facilities.

Compounded drug products

The NDC directory also contains data on finished compounded human drug products that contain Sirolimus and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Sirolimus NDC to their finished compounded human drug products, they may choose to do so.

click here to find a list of Sirolimus suppliers with NDC on PharmaCompass.

Sirolimus GMP

Sirolimus Active pharmaceutical ingredient (API) is produced in GMP-certified manufacturing facility.

GMP stands for Good Manufacturing Practices, which is a system used in the pharmaceutical industry to make sure that goods are regularly produced and monitored in accordance with quality standards. The FDA’s current Good Manufacturing Practices requirements are referred to as cGMP or current GMP which indicates that the company follows the most recent GMP specifications. The World Health Organization (WHO) has its own set of GMP guidelines, called the WHO GMP. Different countries can also set their own guidelines for GMP like China (Chinese GMP) or the EU (EU GMP).

PharmaCompass offers a list of Sirolimus GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, API price, and more, enabling you to easily find the right Sirolimus GMP manufacturer or Sirolimus GMP API supplier for your needs.

Sirolimus CoA

A Sirolimus CoA (Certificate of Analysis) is a formal document that attests to Sirolimus's compliance with Sirolimus specifications and serves as a tool for batch-level quality control.

Sirolimus CoA mostly includes findings from lab analyses of a specific batch. For each Sirolimus CoA document that a company creates, the USFDA specifies specific requirements, such as supplier information, material identification, transportation data, evidence of conformity and signature data.

Sirolimus may be tested according to a variety of international standards, such as European Pharmacopoeia (Sirolimus EP), Sirolimus JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Sirolimus USP).

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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