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List of Japan Drug Master File (JDMF) for PREVPAC-1 Active Pharmaceutical Ingredient submitted to the Review Authority in Japan (PMDA) and listed on PharmaCompass.com

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221MF10008
Alembic Road, Vadodara 390 003, Guj...
2009-01-13
2009-01-13
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2008-09-09
2008-01-23
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2006-08-11
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  • TABLET;ORAL - 250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
  • TABLET;ORAL - 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
  • FOR SUSPENSION;ORAL - 125MG/5ML
  • FOR SUSPENSION;ORAL - 250MG/5ML
  • CAPSULE, TABLET, CAPSULE, DELAYED REL PELLETS;ORAL - 500MG;500MG;30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
  • TABLET, EXTENDED RELEASE;ORAL - 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
  • CAPSULE, TABLET, CAPSULE, DELAYED RELEASE;ORAL - 500MG,N/A,N/A;N/A,500MG,N/A;N/A,N/A,20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Looking for 81103-11-9 / Clarithromycin API manufacturers, exporters & distributors?

Clarithromycin manufacturers, exporters & distributors 1

48

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

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

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

API | Excipient name

Clarithromycin

Synonyms

81103-11-9, Biaxin, 6-o-methylerythromycin, Klaricid, 6-o-methylerythromycin a, Abbott-56268

Cas Number

81103-11-9

Unique Ingredient Identifier (UNII)

H1250JIK0A

About Clarithromycin

A semisynthetic macrolide antibiotic derived from ERYTHROMYCIN that is active against a variety of microorganisms. It can inhibit protein synthesis in bacteria by reversibly binding to the 50S ribosomal subunits. This inhibits the translocation of aminoacyl transfer-RNA and prevents peptide chain elongation.

PREVPAC-1 Manufacturers

A PREVPAC-1 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of PREVPAC-1, including repackagers and relabelers. The FDA regulates PREVPAC-1 manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. PREVPAC-1 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 PREVPAC-1 manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

PREVPAC-1 Suppliers

A PREVPAC-1 supplier is an individual or a company that provides PREVPAC-1 active pharmaceutical ingredient (API) or PREVPAC-1 finished formulations upon request. The PREVPAC-1 suppliers may include PREVPAC-1 API manufacturers, exporters, distributors and traders.

click here to find a list of PREVPAC-1 suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

PREVPAC-1 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 PREVPAC-1 Drug Master File in Japan (PREVPAC-1 JDMF) empowers PREVPAC-1 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 PREVPAC-1 JDMF during the approval evaluation for pharmaceutical products. At the time of PREVPAC-1 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 PREVPAC-1 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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