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DRUG PRODUCT COMPOSITIONS0
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API SUPPLIERS
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USDMF
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Alchem offers Phytochemical APIs for Pharmaceuticals, Cosmetics and Nutraceuticals// FDA-inspected and EU-GMP certified.
Date of Issue : 2022-05-27
Valid Till : 2025-05-26
Written Confirmation Number : WC-0006
Address of the Firm : 25/2, Main Mathura Road, Village Kalli, Ballabgarh, Faridabad-121 004, Haryana, ...
Nuray is an expert in the synthesis of Niche novel APIs, the first to launch Generics, NCEs, Advanced Intermediates // USFDA certified.
Date of Issue : 2024-02-20
Valid Till : 2026-12-06
Written Confirmation Number : WC-0416
Address of the Firm : Plot No. 111 SIDCO Industrial Estate, Kakkalur Thiruvallur-602003 Tamil Nadu, In...
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Nuray is an expert in the synthesis of Niche novel APIs, the first to launch Generics, NCEs, Advanced Intermediates // USFDA certified.
Registrant Name : Pharmapia Co., Ltd.
Registration Date : 2023-07-25
Registration Number : 20230725-211-J-1523
Manufacturer Name : Nuray Chemicals Private Limi...
Manufacturer Address : No.111, SIDCO Industrial Estate, Kakkalur, Thiruvallur District, Tamil Nadu-602 003, ...
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Alchem offers Phytochemical APIs for Pharmaceuticals, Cosmetics and Nutraceuticals// FDA-inspected and EU-GMP certified.
About the Company : Alchem International, established in 1935, is a pioneer in phytochemicals, providing plant-derived active pharmaceutical ingredients to the pharmaceutical, cosmetic and nutraceutic...
TransoPharm USA works in the Sourcing and Management of Active Pharmaceutical Ingredients.
About the Company : Transo-Pharm, a fully licensed and certified distributor, specializes in pharmaceutical components for the health and veterinary industries. It offers support to clients throughout...
Experts in producing high-quality APIs from natural sources, specializing in advanced extraction and isolation techniques.
About the Company : Phytex Australia specializes in the contract manufacturing of APIs from natural resources, serving global pharmaceutical and research sectors. From R&D to commercial production, we...
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
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, ...
Veranova: A CDMO that manages complexity with confidence.
About the Company : Veranova is a global leader in the development and manufacturing of specialist and complex APIs for pharma and biotech customers. We have over 50 years of experience navigating the...
Nuray is an expert in the synthesis of Niche novel APIs, the first to launch Generics, NCEs, Advanced Intermediates // USFDA certified.
About the Company : Established in 2012, Nuray Chemicals Pvt Ltd is an API manufacturer for highly regulated markets. Its manufacturing facility with state-of-the-art R&D is located near Chennai in th...
HRV Global Life Sciences - Market Expansion Leader in Pharmaceuticals.
About the Company : HRV Global is a leading global manufacturer, seller & exporter of a wide range of APIs, advanced intermediates, pellets, food grade chemicals, food additives & food ingredients. It...
Tenatra connects Indian manufacturers with global buyers through active partners in Germany, Switzerland, Belgium, Spain & Turkey.
About the Company : Tenatra International was established as a proprietorship firm in 1999. It got off to a very good start, supporting clients in the United States, Mexico and Europe. As business opp...
Farmhispania Group, a leading European CDMO in HPAPI Technologies & High Potency Fermentation.
About the Company : Farmhispania Group comprises two companies in Spain: Farmhispania in Barcelona and Rolabo in Zaragoza. Since its inception, the group has consistently invested in advanced equipmen...
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API Imports and Exports
Drugs in Development
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DOSAGE - TABLET;ORAL - 0.025MG;2.5MG
USFDA APPLICATION NUMBER - 12462
DOSAGE - INJECTABLE;INJECTION - 0.14MG/ML;10M...DOSAGE - INJECTABLE;INJECTION - 0.14MG/ML;10MG/ML
USFDA APPLICATION NUMBER - 19678
DOSAGE - SOLUTION;INTRAVENOUS - 0.25MG/5ML (0...DOSAGE - SOLUTION;INTRAVENOUS - 0.25MG/5ML (0.05MG/ML)
USFDA APPLICATION NUMBER - 21146
DOSAGE - SOLUTION;INTRAVENOUS - 0.5MG/5ML (0....DOSAGE - SOLUTION;INTRAVENOUS - 0.5MG/5ML (0.1MG/ML)
USFDA APPLICATION NUMBER - 21146
DOSAGE - SOLUTION;INTRAVENOUS - 1MG/10ML (0.1...DOSAGE - SOLUTION;INTRAVENOUS - 1MG/10ML (0.1MG/ML)
USFDA APPLICATION NUMBER - 21146
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DATA COMPILATION #PharmaFlow
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Global Sales Information
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REF. STANDARDS & IMPURITIES
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ABOUT THIS PAGE
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PharmaCompass offers a list of Atropine Sulfate 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 Atropine Sulfate manufacturer or Atropine Sulfate supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Atropine Sulfate manufacturer or Atropine Sulfate supplier.
PharmaCompass also assists you with knowing the Atropine Sulfate API Price utilized in the formulation of products. Atropine Sulfate API Price is not always fixed or binding as the Atropine Sulfate Price is obtained through a variety of data sources. The Atropine Sulfate Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Atropine Sulfate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Atropine Sulfate, including repackagers and relabelers. The FDA regulates Atropine Sulfate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Atropine Sulfate 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 Atropine Sulfate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Atropine Sulfate supplier is an individual or a company that provides Atropine Sulfate active pharmaceutical ingredient (API) or Atropine Sulfate finished formulations upon request. The Atropine Sulfate suppliers may include Atropine Sulfate API manufacturers, exporters, distributors and traders.
click here to find a list of Atropine Sulfate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Atropine Sulfate DMF (Drug Master File) is a document detailing the whole manufacturing process of Atropine Sulfate active pharmaceutical ingredient (API) in detail. Different forms of Atropine Sulfate DMFs exist exist since differing nations have different regulations, such as Atropine Sulfate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Atropine Sulfate DMF submitted to regulatory agencies in the US is known as a USDMF. Atropine Sulfate USDMF includes data on Atropine Sulfate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Atropine Sulfate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Atropine Sulfate 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 Atropine Sulfate Drug Master File in Japan (Atropine Sulfate JDMF) empowers Atropine Sulfate 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 Atropine Sulfate JDMF during the approval evaluation for pharmaceutical products. At the time of Atropine Sulfate 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 Atropine Sulfate 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 Atropine Sulfate Drug Master File in Korea (Atropine Sulfate KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Atropine Sulfate. The MFDS reviews the Atropine Sulfate KDMF as part of the drug registration process and uses the information provided in the Atropine Sulfate KDMF to evaluate the safety and efficacy of the drug.
After submitting a Atropine Sulfate 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 Atropine Sulfate API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Atropine Sulfate suppliers with KDMF on PharmaCompass.
A Atropine Sulfate CEP of the European Pharmacopoeia monograph is often referred to as a Atropine Sulfate Certificate of Suitability (COS). The purpose of a Atropine Sulfate CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Atropine Sulfate EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Atropine Sulfate to their clients by showing that a Atropine Sulfate CEP has been issued for it. The manufacturer submits a Atropine Sulfate CEP (COS) as part of the market authorization procedure, and it takes on the role of a Atropine Sulfate CEP holder for the record. Additionally, the data presented in the Atropine Sulfate CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Atropine Sulfate DMF.
A Atropine Sulfate CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Atropine Sulfate CEPs may be accepted in nations that are not members of the Ph. Eur. at the discretion of the authorities there.
click here to find a list of Atropine Sulfate suppliers with CEP (COS) on PharmaCompass.
A Atropine Sulfate written confirmation (Atropine Sulfate WC) is an official document issued by a regulatory agency to a Atropine Sulfate manufacturer, verifying that the manufacturing facility of a Atropine Sulfate active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Atropine Sulfate APIs or Atropine Sulfate finished pharmaceutical products to another nation, regulatory agencies frequently require a Atropine Sulfate WC (written confirmation) as part of the regulatory process.
click here to find a list of Atropine Sulfate 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 Atropine Sulfate as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Atropine Sulfate 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 Atropine Sulfate 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 Atropine Sulfate and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Atropine Sulfate NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Atropine Sulfate suppliers with NDC on PharmaCompass.
Atropine Sulfate 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 Atropine Sulfate 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 Atropine Sulfate GMP manufacturer or Atropine Sulfate GMP API supplier for your needs.
A Atropine Sulfate CoA (Certificate of Analysis) is a formal document that attests to Atropine Sulfate's compliance with Atropine Sulfate specifications and serves as a tool for batch-level quality control.
Atropine Sulfate CoA mostly includes findings from lab analyses of a specific batch. For each Atropine Sulfate 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.
Atropine Sulfate may be tested according to a variety of international standards, such as European Pharmacopoeia (Atropine Sulfate EP), Atropine Sulfate JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Atropine Sulfate USP).
