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List of Drug Master Files (JDMF) for 033ECH6IFG Active Pharmaceutical Ingredient (API) submitted to the Review Authority in Japan (PMDA). Original Data : PMDA Database

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01 EUROAPI ITALY S. r. l. (1)

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01 Spiramycin (1)

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01 Gabon (1)

EUROAPI ITALY S. r. l.

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Via Angelo Titi, 22/26, Zona ex pun...
2016-04-06
2016-04-06
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Looking for 8025-81-8 / Spiramycin API manufacturers, exporters & distributors?

Spiramycin manufacturers, exporters & distributors 1

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

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

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

API | Excipient name

Spiramycin

Synonyms

Foromacidine a, Spiramycin i, Spiramycin 1, Demycarosylturimycin h, Foromacidin a, Foromacidin

Cas Number

8025-81-8

About Spiramycin

Spiramycin is a macrolide originally discovered as product of Streptomyces ambofaciens, with antibacterial and antiparasitic activities. Although the specific mechanism of action has not been characterized, spiramycin likely inhibits protein synthesis by binding to the 50S subunit of the bacterial ribosome. This agent also prevents placental transmission of toxoplasmosis presumably through a different mechanism, which has not yet been characterized.

033ECH6IFG Manufacturers

A 033ECH6IFG manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of 033ECH6IFG, including repackagers and relabelers. The FDA regulates 033ECH6IFG manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. 033ECH6IFG API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.

033ECH6IFG Suppliers

A 033ECH6IFG supplier is an individual or a company that provides 033ECH6IFG active pharmaceutical ingredient (API) or 033ECH6IFG finished formulations upon request. The 033ECH6IFG suppliers may include 033ECH6IFG API manufacturers, exporters, distributors and traders.

click here to find a list of 033ECH6IFG suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

033ECH6IFG 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 033ECH6IFG Drug Master File in Japan (033ECH6IFG JDMF) empowers 033ECH6IFG 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 033ECH6IFG JDMF during the approval evaluation for pharmaceutical products. At the time of 033ECH6IFG 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 033ECH6IFG suppliers with JDMF on PharmaCompass.

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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