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ABOUT THIS PAGE
A Olodaterol Hydrochloride manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Olodaterol Hydrochloride, including repackagers and relabelers. The FDA regulates Olodaterol Hydrochloride manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Olodaterol Hydrochloride 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 Olodaterol Hydrochloride manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Olodaterol Hydrochloride supplier is an individual or a company that provides Olodaterol Hydrochloride active pharmaceutical ingredient (API) or Olodaterol Hydrochloride finished formulations upon request. The Olodaterol Hydrochloride suppliers may include Olodaterol Hydrochloride API manufacturers, exporters, distributors and traders.
click here to find a list of Olodaterol Hydrochloride suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Olodaterol Hydrochloride DMF (Drug Master File) is a document detailing the whole manufacturing process of Olodaterol Hydrochloride active pharmaceutical ingredient (API) in detail. Different forms of Olodaterol Hydrochloride DMFs exist exist since differing nations have different regulations, such as Olodaterol Hydrochloride USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Olodaterol Hydrochloride DMF submitted to regulatory agencies in the US is known as a USDMF. Olodaterol Hydrochloride USDMF includes data on Olodaterol Hydrochloride's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Olodaterol Hydrochloride USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Olodaterol Hydrochloride 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 Olodaterol Hydrochloride Drug Master File in Korea (Olodaterol Hydrochloride KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Olodaterol Hydrochloride. The MFDS reviews the Olodaterol Hydrochloride KDMF as part of the drug registration process and uses the information provided in the Olodaterol Hydrochloride KDMF to evaluate the safety and efficacy of the drug.
After submitting a Olodaterol Hydrochloride 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 Olodaterol Hydrochloride API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Olodaterol Hydrochloride suppliers with KDMF 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 Olodaterol Hydrochloride as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Olodaterol Hydrochloride 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 Olodaterol Hydrochloride 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 Olodaterol Hydrochloride and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Olodaterol Hydrochloride NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Olodaterol Hydrochloride suppliers with NDC on PharmaCompass.
Olodaterol Hydrochloride 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 Olodaterol Hydrochloride 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 Olodaterol Hydrochloride GMP manufacturer or Olodaterol Hydrochloride GMP API supplier for your needs.
A Olodaterol Hydrochloride CoA (Certificate of Analysis) is a formal document that attests to Olodaterol Hydrochloride's compliance with Olodaterol Hydrochloride specifications and serves as a tool for batch-level quality control.
Olodaterol Hydrochloride CoA mostly includes findings from lab analyses of a specific batch. For each Olodaterol Hydrochloride 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.
Olodaterol Hydrochloride may be tested according to a variety of international standards, such as European Pharmacopoeia (Olodaterol Hydrochloride EP), Olodaterol Hydrochloride JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Olodaterol Hydrochloride USP).
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