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API SUPPLIERS
Inke S.A: APIs manufacturing plant.
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ASMF, CN
Deccan Nutraceuticals: A global leader in the integrated development, manufacturing, and marketing of pharmaceutical products.
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
Rochem, your partner in developing, sourcing, and supplying pharmaceutical & animal health ingredients of Chinese origin.
DKSH is your trusted partner for companies looking to grow their business in Asia & beyond.
Vamsi Labs is one of the major manufacturers of Anti-asthmatic, Anti-migraine & Anti-psychotic APIs.
Neuland Laboratories- A dedicated 100% API provider.
EU-WC
NDC
ASMF
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USDMF
Inke S.A: APIs manufacturing plant.
GDUFA
DMF Review : Complete
Rev. Date : 2025-01-29
Pay. Date : 2024-12-09
DMF Number : 34411
Submission : 2024-06-25
Status :
Type : II
Neuland Laboratories- A dedicated 100% API provider.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 34294
Submission : 2019-12-31
Status :
Type : II
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Neuland Laboratories- A dedicated 100% API provider.
Date of Issue : 2022-07-28
Valid Till : 2025-06-16
Written Confirmation Number : WC-0036
Address of the Firm : Unit-1, Sy. No. 347, 473, 474, 490/2, Bonthapally Village, Veerabhadraswamy, Tem...
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DOSAGE - POWDER;INHALATION - 15.6MCG/INH;27.5...DOSAGE - POWDER;INHALATION - 15.6MCG/INH;27.5MCG/INH
USFDA APPLICATION NUMBER - 207930
DOSAGE - POWDER;INHALATION - EQ 75MCG BASE
USFDA APPLICATION NUMBER - 22383
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ABOUT THIS PAGE
19
PharmaCompass offers a list of Indacaterol Maleate 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 Indacaterol Maleate manufacturer or Indacaterol Maleate supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Indacaterol Maleate manufacturer or Indacaterol Maleate supplier.
PharmaCompass also assists you with knowing the Indacaterol Maleate API Price utilized in the formulation of products. Indacaterol Maleate API Price is not always fixed or binding as the Indacaterol Maleate Price is obtained through a variety of data sources. The Indacaterol Maleate Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Indacaterol Maleate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Indacaterol Maleate, including repackagers and relabelers. The FDA regulates Indacaterol Maleate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Indacaterol Maleate 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 Indacaterol Maleate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Indacaterol Maleate supplier is an individual or a company that provides Indacaterol Maleate active pharmaceutical ingredient (API) or Indacaterol Maleate finished formulations upon request. The Indacaterol Maleate suppliers may include Indacaterol Maleate API manufacturers, exporters, distributors and traders.
click here to find a list of Indacaterol Maleate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Indacaterol Maleate DMF (Drug Master File) is a document detailing the whole manufacturing process of Indacaterol Maleate active pharmaceutical ingredient (API) in detail. Different forms of Indacaterol Maleate DMFs exist exist since differing nations have different regulations, such as Indacaterol Maleate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Indacaterol Maleate DMF submitted to regulatory agencies in the US is known as a USDMF. Indacaterol Maleate USDMF includes data on Indacaterol Maleate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Indacaterol Maleate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Indacaterol Maleate suppliers with USDMF 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 Indacaterol Maleate Drug Master File in Korea (Indacaterol Maleate KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Indacaterol Maleate. The MFDS reviews the Indacaterol Maleate KDMF as part of the drug registration process and uses the information provided in the Indacaterol Maleate KDMF to evaluate the safety and efficacy of the drug.
After submitting a Indacaterol Maleate 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 Indacaterol Maleate API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Indacaterol Maleate suppliers with KDMF on PharmaCompass.
A Indacaterol Maleate written confirmation (Indacaterol Maleate WC) is an official document issued by a regulatory agency to a Indacaterol Maleate manufacturer, verifying that the manufacturing facility of a Indacaterol Maleate active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Indacaterol Maleate APIs or Indacaterol Maleate finished pharmaceutical products to another nation, regulatory agencies frequently require a Indacaterol Maleate WC (written confirmation) as part of the regulatory process.
click here to find a list of Indacaterol Maleate 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 Indacaterol Maleate as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Indacaterol Maleate 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 Indacaterol Maleate 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 Indacaterol Maleate and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Indacaterol Maleate NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Indacaterol Maleate suppliers with NDC on PharmaCompass.
Indacaterol Maleate 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 Indacaterol Maleate 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 Indacaterol Maleate GMP manufacturer or Indacaterol Maleate GMP API supplier for your needs.
A Indacaterol Maleate CoA (Certificate of Analysis) is a formal document that attests to Indacaterol Maleate's compliance with Indacaterol Maleate specifications and serves as a tool for batch-level quality control.
Indacaterol Maleate CoA mostly includes findings from lab analyses of a specific batch. For each Indacaterol Maleate 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.
Indacaterol Maleate may be tested according to a variety of international standards, such as European Pharmacopoeia (Indacaterol Maleate EP), Indacaterol Maleate JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Indacaterol Maleate USP).
