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API SUPPLIERS
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USDMF
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Enaltec Labs –Delivering complex APIs with precision, innovation, and global compliance.
Date of Issue : 2022-12-16
Valid Till : 2025-12-15
Written Confirmation Number : WC-0544
Address of the Firm : Plot No. 825,826,827, Industrial Area, Sector-Ill, Pithampur, Dhar-454774, Madhy...
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LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
About the Company : LGM Pharma is a global leader in sourcing APIs, including hard-to-find drug substances, for pharmaceutical and biotech industries. LGM also operates as a full-service drug product ...
Enaltec Labs –Delivering complex APIs with precision, innovation, and global compliance.
About the Company : Enaltec, founded in 2006, specializes in developing and manufacturing complex, small-volume, technology-driven APIs at competitive prices, leveraging the India advantage for global...
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Drugs in Development
Lead Product(s) : Alirocumab, Pravastatin, Simvastatin, Fluvastatin, Atorvastatin
Therapeutic Area : Cardiology/Vascular Diseases
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Regeneron Pharmaceuticals
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Alirocumab is a Antibody drug candidate, which is currently being evaluated in phase III clinical studies for the treatment of Hypercholesterolemia.
Product Name : Undisclosed
Product Type : Antibody, Unconjugated
Upfront Cash : Inapplicable
April 08, 2014
Lead Product(s) : ABBV-722,Midazolam,Metformin,Digoxin,Pitavastatin,Sitagliptin Phosphate
Therapeutic Area : Undisclosed
Highest Development Status : Phase I
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : ABBV-722 is a small molecule drug, which is currently being evaluated in Phase I clinical studies for the treatment of undisclosed medical condition.
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Inapplicable
May 05, 2026
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REF. STANDARDS & IMPURITIES
ABOUT THIS PAGE
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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, 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.
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, and COA related information on PhamaCompass.
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, and COA related information on PharmaCompass.
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.
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.
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.
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.
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).
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.
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.
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 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, and more, enabling you to easily find the right Pitavastatin Calcium GMP manufacturer or Pitavastatin Calcium GMP API supplier for your needs.
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).
