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

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01 Alembic Pharmaceuticals Limited (1)

02 Huangshi Shixing Pharmaceutical Co. , Ltd. (1)

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01 ROXITHROMYCIN (1)

02 Roxithromycin (1)

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01 China (1)

02 India (1)

URL Supplier Web Content
218MF10414
Alembic Road, Vadodara 390 003, Guj...
2019-06-25
2006-04-14
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URL Supplier Web Content
302MF10125
No. 73 East Jinshan Road, Huangjins...
2023-10-04
2020-10-08
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Looking for 80214-83-1 / Roxithromycin API manufacturers, exporters & distributors?

Roxithromycin manufacturers, exporters & distributors 1

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

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

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

API | Excipient name

Roxithromycin

Synonyms

80214-83-1, Roxithromycine, Roxithromycinum, Roxitromicina, Ru 965, Ru 28965

Cas Number

80214-83-1

Unique Ingredient Identifier (UNII)

21KOF230FA

About Roxithromycin

Semisynthetic derivative of erythromycin. It is concentrated by human phagocytes and is bioactive intracellularly. While the drug is active against a wide spectrum of pathogens, it is particularly effective in the treatment of respiratory and genital tract infections.

Alpharma Brand of Roxithromycin Manufacturers

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

Alpharma Brand of Roxithromycin Suppliers

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

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

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

Alpharma Brand of Roxithromycin Manufacturers | Traders | Suppliers

Alpharma Brand of Roxithromycin Manufacturers, Traders, Suppliers 1
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We have 2 companies offering Alpharma Brand of Roxithromycin

Get in contact with the supplier of your choice:

  1. Alembic Pharmaceuticals Limited
  2. Huangshi Shixing 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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