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List of Drug Master Files (DMF) of Rosuvastatin Calcium Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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01 Centrient Pharmaceuticals (1)

02 Minakem (formerly Delmar Chemicals) (1)

03 Amoli Organics (2)

04 Apotex Pharmachem (1)

05 Aurobindo Pharma Limited (1)

06 Biocon (2)

07 CTX Lifesciences (1)

08 Changzhou Pharmaceutical Factory (3)

09 Chromo Laboratories (2)

10 Glenmark Life Sciences (2)

11 HEC Pharm (1)

12 Hetero Drugs (1)

13 Innovare Labs (1)

14 Jiangsu Alpha Pharmaceutical Co., Ltd. (1)

15 Jubilant Generics (1)

16 KOLON Life Science, Inc (1)

17 Lee Pharma (1)

18 Lek Pharmaceuticals (3)

19 Lupin Ltd (1)

20 MSN Laboratories (3)

21 Macleods Pharmaceuticals Limited (1)

22 Mankind Pharma (1)

23 Melody Healthcare Pvt Ltd (1)

24 Morepen Laboratories (2)

25 Nenter & Co., Inc. (1)

26 Ningbo Menovo Pharmaceutical (2)

27 Shanghai Desano Bio-Pharmaceutical Co., Ltd. (1)

28 Sun Pharmaceutical Industries Limited (1)

29 Teva API (3)

30 Viatris (1)

31 ZHEJIANG HONGYUAN PHARMACEUTICAL CO. - LTD (1)

32 Zhejiang Hisun Pharmaceutical (1)

33 Zhejiang Neo-Dankong Pharm. Co.,Ltd. (3)

34 Zhejiang Yongtai Technology (1)

35 Zydus Lifesciences (1)

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01 ROSUVASTATIN CALCIUM (18)

02 ROSUVASTATIN CALCIUM (AMORPHOUS) (1)

03 ROSUVASTATIN CALCIUM (BULK) (1)

04 ROSUVASTATIN CALCIUM (NON-STERILE DRUG SUBSTANCE) (1)

05 ROSUVASTATIN CALCIUM (PROCESS B) (1)

06 ROSUVASTATIN CALCIUM (PROCESS C) (1)

07 ROSUVASTATIN CALCIUM (PRODUCT CODE 8004368) (1)

08 ROSUVASTATIN CALCIUM (ROUTE CODE: RSF) (1)

09 ROSUVASTATIN CALCIUM AMORPHOUS (1)

10 ROSUVASTATIN CALCIUM INTERMEDIATE (1)

11 ROSUVASTATIN CALCIUM INTERMEDIATE (R-1) (1)

12 ROSUVASTATIN CALCIUM INTERMEDIATE (R-2) (1)

13 ROSUVASTATIN CALCIUM INTERMEDIATE (R1) (1)

14 ROSUVASTATIN CALCIUM INTERMEDIATE (R1.5) (1)

15 ROSUVASTATIN CALCIUM INTERMEDIATE (RJS3) (1)

16 ROSUVASTATIN CALCIUM NON-STERILE BULK DRUG SUBSTANCE (1)

17 ROSUVASTATIN CALCIUM PROCESS -2 (1)

18 ROSUVASTATIN CALCIUM PROCESS G (1)

19 ROSUVASTATIN CALCIUM PROCESS G 2410 (1)

20 ROSUVASTATIN CALCIUM USP (11)

21 ROSUVASTATIN CALCIUM USP [ROUTE CODE - "RT"] (1)

22 ROSUVASTATIN CALCIUM USP [ROUTE CODE - RV"] (1)

23 ROSUVASTATIN CALCIUM, NON- STERILE BULK DRUG SUBSTANCES (1)

24 RSM (ROSUVASTATIN METHYL ESTER, ROSUVASTATIN CALCIUM INTERMEDIATE) (1)

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01 Canada (2)

02 China (15)

03 India (25)

04 Israel (3)

05 Netherlands (1)

06 Slovenia (3)

07 South Korea (1)

08 U.S.A (1)

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01 Active (44)

02 Inactive (7)

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01 Complete (24)

02 Blank (27)

31410
Active
2017-03-28
Complete
2017-11-17
2017-05-23
II
Centrient Pharmaceuticals

CPhI Japan

Not Confirmed

envelop Contact Supplier
29190
Active
2015-12-03
Complete
2016-04-08
2015-09-25
II
Minakem Delmar

CPhI Japan

Not Confirmed

envelop Contact Supplier
URL Supplier Web Content
20629
Active
2007-06-22
N/A
II
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URL Supplier Web Content
20705
Active
2007-07-18
Complete
2013-10-05
2013-09-27
II
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URL Supplier Web Content
20592
Active
2007-06-12
N/A
II
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URL Supplier Web Content
20765
Active
2007-08-09
N/A
II
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URL Supplier Web Content
20712
Active
2007-07-25
Complete
2013-07-11
2013-07-03
II
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20671
Active
2007-07-12
Complete
2013-01-31
2013-01-02
II
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URL Supplier Web Content
20751
Active
2007-07-27
N/A
II
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PHARMACOMPASS
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your Marketing & Sales content
URL Supplier Web Content
20677
Active
2007-07-02
N/A
II
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Looking for 147098-20-2 / Rosuvastatin Calcium API manufacturers, exporters & distributors?

Rosuvastatin Calcium manufacturers, exporters & distributors 1

11

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 USDMF

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

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

click here to find a list of Rosuvastatin Calcium suppliers with USDMF 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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