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

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2019-09-11
2015-08-06
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  • CAPSULE;ORAL - EQ 10MG BASE
  • CAPSULE;ORAL - EQ 20MG BASE
  • CAPSULE;ORAL - EQ 40MG BASE
  • CAPSULE;ORAL - EQ 5MG BASE
  • TABLET;ORAL - EQ 10MG BASE
  • TABLET;ORAL - EQ 20MG BASE
  • TABLET;ORAL - EQ 40MG BASE
  • TABLET;ORAL - EQ 5MG BASE

Looking for 147098-20-2 / Rosuvastatin Calcium API manufacturers, exporters & distributors?

Rosuvastatin Calcium manufacturers, exporters & distributors 1

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

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

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

API | Excipient name

Rosuvastatin Calcium

Synonyms

147098-20-2, Crestor, Rosuvastatin hemicalcium, Fortius, Rostar, Rosuvastatin calcium salt

Cas Number

147098-20-2

Unique Ingredient Identifier (UNII)

83MVU38M7Q

About Rosuvastatin Calcium

A HYDROXYMETHYLGLUTARYL-COA-REDUCTASE INHIBITOR, or statin, that reduces the plasma concentrations of LDL-CHOLESTEROL; APOLIPOPROTEIN B, and TRIGLYCERIDES while increasing HDL-CHOLESTEROL levels in patients with HYPERCHOLESTEROLEMIA and those at risk for CARDIOVASCULAR DISEASES.

Rosuvastatin Calcium Manufacturers

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

Rosuvastatin Calcium Suppliers

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

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

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

Rosuvastatin Calcium Manufacturers | Traders | Suppliers

Rosuvastatin Calcium Manufacturers, Traders, Suppliers 1
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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