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Chemistry

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Also known as: Pitavastatin calcium, 147526-32-7, Livalo, Nisvastatin, Nk-104, Itavastatin calcium
Molecular Formula
C50H46CaF2N2O8
Molecular Weight
881.0  g/mol
InChI Key
RHGYHLPFVJEAOC-FFNUKLMVSA-L
FDA UNII
IYD54XEG3W

Pitavastatin
Pitavastatin Calcium is a calcium salt formulation of pitavastatin, a novel statin that induces plaque regression and elevates HDL-cholesterol levels.
1 2D Structure

Pitavastatin

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
calcium;(E,3R,5S)-7-[2-cyclopropyl-4-(4-fluorophenyl)quinolin-3-yl]-3,5-dihydroxyhept-6-enoate
2.1.2 InChI
InChI=1S/2C25H24FNO4.Ca/c2*26-17-9-7-15(8-10-17)24-20-3-1-2-4-22(20)27-25(16-5-6-16)21(24)12-11-18(28)13-19(29)14-23(30)31;/h2*1-4,7-12,16,18-19,28-29H,5-6,13-14H2,(H,30,31);/q;;+2/p-2/b2*12-11+;/t2*18-,19-;/m11./s1
2.1.3 InChI Key
RHGYHLPFVJEAOC-FFNUKLMVSA-L
2.1.4 Canonical SMILES
C1CC1C2=NC3=CC=CC=C3C(=C2C=CC(CC(CC(=O)[O-])O)O)C4=CC=C(C=C4)F.C1CC1C2=NC3=CC=CC=C3C(=C2C=CC(CC(CC(=O)[O-])O)O)C4=CC=C(C=C4)F.[Ca+2]
2.1.5 Isomeric SMILES
C1C(C1)C2=NC3=CC=CC=C3C(=C2/C=C/[C@@H](O)C[C@@H](O)CC(=O)[O-])C4=CC=C(C=C4)F.C1C(C1)C2=NC3=CC=CC=C3C(=C2/C=C/[C@@H](O)C[C@@H](O)CC(=O)[O-])C4=CC=C(C=C4)F.[Ca+2]
2.2 Other Identifiers
2.2.1 UNII
IYD54XEG3W
2.3 Synonyms
2.3.1 MeSH Synonyms

1. (e,3r,5s)-7-(2-cyclopropyl-4-(4-fluorophenyl)quinolin-3-yl)-3,5-dihydroxyhept-6-enoic Acid

2. Itavastatin

3. Itavastatin Calcium

4. Nisvastatin

5. Nk 104

6. Nk-104

7. P 872441

8. P-872441

9. Pitavastatin

10. Pitavastatin Calcium

11. Pitavastatin Lactone

2.3.2 Depositor-Supplied Synonyms

1. Pitavastatin Calcium

2. 147526-32-7

3. Livalo

4. Nisvastatin

5. Nk-104

6. Itavastatin Calcium

7. Pitavastatin Calcium Salt

8. Calcium (3r,5s,e)-7-(2-cyclopropyl-4-(4-fluorophenyl)quinolin-3-yl)-3,5-dihydroxyhept-6-enoate

9. Nk 104

10. Iyd54xeg3w

11. Chebi:71258

12. Calcium;(e,3r,5s)-7-[2-cyclopropyl-4-(4-fluorophenyl)quinolin-3-yl]-3,5-dihydroxyhept-6-enoate

13. P-872441

14. Pitavastatin Calcium (jan)

15. Pitavastatin Calcium [jan]

16. Alipza

17. Flovas

18. Livazo

19. Unii-iyd54xeg3w

20. Nk 104 (acid)

21. Redevant

22. Ccris 8652

23. Livalo (tn)

24. Schembl22720

25. Bis((3r,5s,6e)-7-(2-cyclopropyl-4-(4-fluorophenyl)-3-quinolyl)-3,5-dihydroxy-6-heptenoate), Monocalcium Salt

26. Chembl1237061

27. Dtxsid4046448

28. Chebi:94569

29. Pitavastatin Hemicalcium;nk-104

30. Nks-104

31. Act02718

32. Mfcd01937979

33. Pitavastatin Calcium [mart.]

34. Pitavastatin Calcium [who-dd]

35. Akos015900407

36. Pitavastatin Calcium Salt [mi]

37. Am84441

38. Ks-1220

39. (+)-monocalciumbis{(3r,5s,6e)-7-[2-cyclopropyl-4-(4-fluorophenyl)-3-quinolyl]-3,5-dihydroxy-6-hepten

40. 111ge002

41. 6-heptenoic Acid, 7-(2-cyclopropyl-4-(4-fluorophenyl)-3-quinolinyl)-3,5-dihydroxy-, Calcium Salt (2:1), (s-(r*,s*-(e)))-

42. Pitavastatin Calcium [orange Book]

43. D01862

44. Q-201590

45. Q27139472

46. (+)-monocalciumbis[(3r,5s,6e)-7-[2-cyclopropyl-4(4-fluorophenyl)-3-quinolyl]3,5-dihydroxy-6-hepteno Ate]

47. (3r,5s,6e)-7-[2-cyclopropyl-4-(4-fluorophenyl)-3-quinolinyl]-3,5-dihydroxy-6-heptenoic Acid Hemicalcium Salt

48. Bis((3r,5s,6e)-7-(2-cyclopropyl-4-(4-fluorophenyl)-3-quinolyl)-3,5-dihydroxy-6-heptenoate) Monocalcium Salt

49. Calcium (3r,5s,e)-7-(2-cyclopropyl-4-(4-fluorophenyl)-quinolin-3-yl)-3,5-dihydroxyhept-6-enoate

50. Calcium Bis{(3r,5s,6e)-7-[2-cyclopropyl-4-(4-fluorophenyl)quinolin-3-yl]-3,5-dihydroxyhept-6-enoate}

2.4 Create Date
2005-10-11
3 Chemical and Physical Properties
Molecular Weight 881.0 g/mol
Molecular Formula C50H46CaF2N2O8
Hydrogen Bond Donor Count4
Hydrogen Bond Acceptor Count12
Rotatable Bond Count14
Exact Mass880.2848136 g/mol
Monoisotopic Mass880.2848136 g/mol
Topological Polar Surface Area187 Ų
Heavy Atom Count63
Formal Charge0
Complexity626
Isotope Atom Count0
Defined Atom Stereocenter Count4
Undefined Atom Stereocenter Count0
Defined Bond Stereocenter Count2
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count3
4 Drug and Medication Information
4.1 Drug Information
1 of 2  
Drug NameLivalo
PubMed HealthPitavastatin (By mouth)
Drug ClassesAntihyperlipidemic
Active IngredientPitavastatin calcium
Dosage FormTablet
RouteOral
Strengtheq 4mg base; eq 2mg base; eq 1mg base
Market StatusPrescription
CompanyKowa

2 of 2  
Drug NameLivalo
PubMed HealthPitavastatin (By mouth)
Drug ClassesAntihyperlipidemic
Active IngredientPitavastatin calcium
Dosage FormTablet
RouteOral
Strengtheq 4mg base; eq 2mg base; eq 1mg base
Market StatusPrescription
CompanyKowa

5 Pharmacology and Biochemistry
5.1 MeSH Pharmacological Classification

Hydroxymethylglutaryl-CoA Reductase Inhibitors

Compounds that inhibit HYDROXYMETHYLGLUTARYL COA REDUCTASES. They have been shown to directly lower CHOLESTEROL synthesis. (See all compounds classified as Hydroxymethylglutaryl-CoA Reductase Inhibitors.)


5.2 FDA Pharmacological Classification
5.2.1 Pharmacological Classes
Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]; HMG-CoA Reductase Inhibitor [EPC]

Listed Suppliers

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LGM Pharma

U.S.A
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  • WHO-GMP

Virtual BoothLGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.

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Pitavastatin

About the Company : LGM Pharma is a global leader in sourcing hard-to-find APIs and intermediates for the pharmaceutical and biotech industries. LGM is also a full service CDMO providing formulation, ...

LGM Pharma is a global leader in sourcing hard-to-find APIs and intermediates for the pharmaceutical and biotech industries. LGM is also a full service CDMO providing formulation, analytical method development and testing, and commercial manufacturing. LGM Pharma offers custom API synthesis, analytical development, and regulatory services. With a network of over 300 accredited CGMP manufacturing partners, LGM provides unparalleled supply chain security. And, with over 100,000 square feet of FDA-inspected cGMP manufacturing and warehouse capacity, LGM Pharma provides a one-stop solution for solid dose, powder, semi-solid and liquid drugs.
LGM Pharma CB

02

Cophex
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Pitavastatin

About the Company : Aptra Synthesis Private Limited, is a reliable and vertically integrated manufacturer of APIs and intermediates, boasting state-of-the-art manufacturing facilities that adhere to G...

Aptra Synthesis Private Limited, is a reliable and vertically integrated manufacturer of APIs and intermediates, boasting state-of-the-art manufacturing facilities that adhere to GMP standards. We take great pride in producing top-notch intermediates through our fully backward-integrated process. Aptra Synthesis Private Limited (ASPL) stands as one of the rapidly emerging manufacturers of Active Pharmaceutical Ingredients (APIs), Pellets (Semi-finished Formulations), and Intermediates.
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03

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Pitavastatin Calcium

About the Company : Boryung Pharmaceutical, aiming at the best not the biggest, started from the pharmacy since 1957 and has put a strong presence in Korean market as one of TOP leading pharmaceutical...

Boryung Pharmaceutical, aiming at the best not the biggest, started from the pharmacy since 1957 and has put a strong presence in Korean market as one of TOP leading pharmaceutical companies. Boryung has invested continually on research and development and made continuous efforts to produce high-quality products. Lately by developing new drug of Fimasartan(new chemical entity by Boryung's technology) with its own R&D, Boryung is accelerating its R&D activity to become global health care company. Also, synthetic API's & oncology formulation are core competence and have been attractive to many customers in regulated & non-regulated markets.
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04

Cophex
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Pitavastatin

About the Company : Changzhou Pharmaceutical Factory (CPF) is a subsidiary company of Shanghai Pharma Holdings Co., Ltd., It is headquartered in Changzhou, Jiangsu Province, China. The company was fou...

Changzhou Pharmaceutical Factory (CPF) is a subsidiary company of Shanghai Pharma Holdings Co., Ltd., It is headquartered in Changzhou, Jiangsu Province, China. The company was founded in 1949 by (Tan Ruiting) with a registered capital of 108 million yuan and the company was restructured as a Changzhou pharmaceutical Factory under the aegis of the Shanghai Pharma Group. The company mainly involves leading pharmaceutical manufacturers a wide range of key Intermediates, Active pharmaceutical ingredients, and Finished Formulations that meet with global standards.
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05

CHEMO

Spain
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CHEMO

Spain
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Pitavastatin

About the Company : More than 35 years of dedication to quality, service and pursuit of excellence, CHEMO was founded by Hugo Sigman, M.D., and Silvia Gold, Biochemist, in Spain (Barcelona), in 1977, ...

More than 35 years of dedication to quality, service and pursuit of excellence, CHEMO was founded by Hugo Sigman, M.D., and Silvia Gold, Biochemist, in Spain (Barcelona), in 1977, and starts business activities trading with pharmaceutical raw materials. In the 80's, the company expanded its operations into the Industrial Business, developing and manufacturing active pharmaceutical ingredients (APIs) in Italy (Industriale Chimica) and in Spain (Quimica Sintetica). In the 90's, CHEMO starts developing and manufacturing high quality and technology finished dosage forms (FDFs).
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06

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Pitavastatin Calcium

About the Company : Enaltec Labs was established in 2006 by a group of young & experienced professionals with the specific objective to develop & produce complex, small volume, technology driven produ...

Enaltec Labs was established in 2006 by a group of young & experienced professionals with the specific objective to develop & produce complex, small volume, technology driven products at competitive prices, thus providing the critical India advantage to generic formulators across the world. The paradigm shift of leading Indian pharmaceutical companies to target high volume and blockbuster products for regulated markets has been the inspiration behind the launch of Enaltec Labs.
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07

Estechpharma

South Korea
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Estechpharma

South Korea
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Pitavastatin Calcium

About the Company : ESTECHPHARMA CO.,LTD., as one of the active pharmaceutical company, is remarkably growing more than 30% every year by concentrating all our efforts into developing new technologies...

ESTECHPHARMA CO.,LTD., as one of the active pharmaceutical company, is remarkably growing more than 30% every year by concentrating all our efforts into developing new technologies by investing more than 15% of the annual turnover into R&D since our foundation in 1996. That is company ideology, challenge and creation. We've succeeded in synthesizing 40 kinds of APIs like Anti-inflammatory medicine, Anti-ulcerants, Anti-hepatitis, Treatments of Alcoholism, and etc secondly or thirdly in the world or firstly in Korea, and have been producing and supplying continuously to our customers.
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08

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Pitavastatin Calcium

About the Company : Guangzhou Tosun Pharmaceutical was founded in 1999, which mainly focuses on importation & exportation of Active Pharmaceutical Ingrediants, Chemical Raw Materials, Intermediate, Ex...

Guangzhou Tosun Pharmaceutical was founded in 1999, which mainly focuses on importation & exportation of Active Pharmaceutical Ingrediants, Chemical Raw Materials, Intermediate, Excipients, Herbal extracts, Formulation of Chinese & Western Medicine. With abundant economic strength, the group has successfully developed to a pharmaceutical group enterprise wich intergrets operation of medicine & related products, processing & manufacturing, and importation & exportation together.
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09

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Pitavastatin

About the Company : Wanbang Biopharmaceuticals is a leading anti-diabetic pharmaceutical company in China and a core member of Fosun Group (SH600196; HK02196). Wanbang Biopharma has been focusing at t...

Wanbang Biopharmaceuticals is a leading anti-diabetic pharmaceutical company in China and a core member of Fosun Group (SH600196; HK02196). Wanbang Biopharma has been focusing at the development, manufacture and sale of pharmaceuticals to address the unmet medical needs in the area of diabetic disease since its establishment in 1981.As the pioneer insulin producer in China, Wanbang has been developed into the largest anti-diabetic pharmaceutical provider of China with a comprehensive product portfolio that covers a wide range of anti-diabetic drugs, serving for more than eight million diabetic patients.
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10

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Pitavastatin

About the Company : Listed company (stock code 002020), professional producer and exporter of APIs, FDF and TCM. CEP and EU(Germany) GMP, TGA, MHRA, EDMF are available .Rich experience on OEM/CM servi...

Listed company (stock code 002020), professional producer and exporter of APIs, FDF and TCM. CEP and EU(Germany) GMP, TGA, MHRA, EDMF are available .Rich experience on OEM/CM service covered tablets, capsules, large volume preparation and powder for injection. Many finished products are exported to EU-market.Main products of APIS : Levofloxacin hemihydrate , Simvastatin , Ciprofloxacin ,Main products of FDF: Simvastatin tablet, Ciprofloxacin tablet,Sertraline tabletMain products of TCM:Kangfuxin Solution
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API Reference Price

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12-Jan-2021
27-Feb-2025
KGS
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Average Price (USD/KGS)

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Total Quantity (KGS)

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ABOUT THIS PAGE

Looking for 147526-32-7 / Pitavastatin API manufacturers, exporters & distributors?

Pitavastatin manufacturers, exporters & distributors 1

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

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

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

API | Excipient name

Pitavastatin

Synonyms

Pitavastatin calcium, 147526-32-7, Livalo, Nisvastatin, Nk-104, Itavastatin calcium

Cas Number

147526-32-7

Unique Ingredient Identifier (UNII)

IYD54XEG3W

About Pitavastatin

Pitavastatin Calcium is a calcium salt formulation of pitavastatin, a novel statin that induces plaque regression and elevates HDL-cholesterol levels.

Pitavastatin Calcium Manufacturers

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

Pitavastatin Calcium Suppliers

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

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

Pitavastatin Calcium USDMF

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

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

click here to find a list of Pitavastatin Calcium suppliers with USDMF on PharmaCompass.

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

Pitavastatin Calcium KDMF

In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.

Pharmaceutical companies submit a Pitavastatin Calcium Drug Master File in Korea (Pitavastatin Calcium KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Pitavastatin Calcium. The MFDS reviews the Pitavastatin Calcium KDMF as part of the drug registration process and uses the information provided in the Pitavastatin Calcium KDMF to evaluate the safety and efficacy of the drug.

After submitting a Pitavastatin Calcium KDMF to the MFDS, the registered manufacturer can provide importers or distributors with the registration number without revealing confidential information to Korean business partners. Applicants seeking to register their Pitavastatin Calcium API can apply through the Korea Drug Master File (KDMF).

click here to find a list of Pitavastatin Calcium suppliers with KDMF on PharmaCompass.

Pitavastatin Calcium WC

A Pitavastatin Calcium written confirmation (Pitavastatin Calcium WC) is an official document issued by a regulatory agency to a Pitavastatin Calcium manufacturer, verifying that the manufacturing facility of a Pitavastatin Calcium active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Pitavastatin Calcium APIs or Pitavastatin Calcium finished pharmaceutical products to another nation, regulatory agencies frequently require a Pitavastatin Calcium WC (written confirmation) as part of the regulatory process.

click here to find a list of Pitavastatin Calcium suppliers with Written Confirmation (WC) on PharmaCompass.

Pitavastatin Calcium NDC

National Drug Code is a comprehensive database maintained by the FDA that contains information on all drugs marketed in the US. This directory includes information about finished drug products, unfinished drug products, and compounded drug products, including those containing Pitavastatin Calcium as an active pharmaceutical ingredient (API).

Finished drug products

The FDA updates the NDC directory daily. The NDC numbers for Pitavastatin Calcium API and other APIs are published in this directory by the FDA.

Unfinished drugs

The NDC unfinished drugs database includes product listing information submitted for all unfinished drugs, such as active pharmaceutical ingredients (APIs), drugs intended for further processing and bulk drug substances for compounding.

Pharmaceutical companies that manufacture Pitavastatin Calcium as an active pharmaceutical ingredient (API) must furnish the FDA with an updated record of all drugs that they produce, prepare, propagate, compound, or process for commercial distribution in the US at their facilities.

Compounded drug products

The NDC directory also contains data on finished compounded human drug products that contain Pitavastatin Calcium and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Pitavastatin Calcium NDC to their finished compounded human drug products, they may choose to do so.

click here to find a list of Pitavastatin Calcium suppliers with NDC on PharmaCompass.

Pitavastatin Calcium GMP

Pitavastatin Calcium Active pharmaceutical ingredient (API) is produced in GMP-certified manufacturing facility.

GMP stands for Good Manufacturing Practices, which is a system used in the pharmaceutical industry to make sure that goods are regularly produced and monitored in accordance with quality standards. The FDA’s current Good Manufacturing Practices requirements are referred to as cGMP or current GMP which indicates that the company follows the most recent GMP specifications. The World Health Organization (WHO) has its own set of GMP guidelines, called the WHO GMP. Different countries can also set their own guidelines for GMP like China (Chinese GMP) or the EU (EU GMP).

PharmaCompass offers a list of Pitavastatin Calcium GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, API price, and more, enabling you to easily find the right Pitavastatin Calcium GMP manufacturer or Pitavastatin Calcium GMP API supplier for your needs.

Pitavastatin Calcium CoA

A Pitavastatin Calcium CoA (Certificate of Analysis) is a formal document that attests to Pitavastatin Calcium's compliance with Pitavastatin Calcium specifications and serves as a tool for batch-level quality control.

Pitavastatin Calcium CoA mostly includes findings from lab analyses of a specific batch. For each Pitavastatin Calcium CoA document that a company creates, the USFDA specifies specific requirements, such as supplier information, material identification, transportation data, evidence of conformity and signature data.

Pitavastatin Calcium may be tested according to a variety of international standards, such as European Pharmacopoeia (Pitavastatin Calcium EP), Pitavastatin Calcium JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Pitavastatin Calcium USP).

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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