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DRUG PRODUCT COMPOSITIONS0
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API SUPPLIERS
Axplora is your partner of choice for complex APIs.
Transo-Pharm GmbH works globally to supply Active Pharmaceutical Ingredients adhering to the highest quality & GMP standards.
Basic Nutrition, your expert for sourcing from China, India and Europe.
Moehs Group, a reference company in the production of pharmaceutical active ingredients.
Pharm-Rx is a reputed global importer and distributor of pharmaceutical active ingredients.
Willow Birch Pharma delivers trusted, high-quality APIs nationwide with unmatched service, compliance, and competitive value.
Anlon Healthcare manufactures high-quality Pharmaceutical Bulk Drugs & Intermediates compliant with FDA, PMDA, KFDA, cGMP & WHO-GMP.
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USDMF
Axplora is your partner of choice for complex APIs.
GDUFA
DMF Review : Complete
Rev. Date : 2014-08-07
Pay. Date : 2013-04-03
DMF Number : 5836
Submission : 1985-03-29
Status :
Type : II
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]CEP/COS
Axplora is your partner of choice for complex APIs.
Certificate Number : R2-CEP 1995-028 - Rev 04
Status : Valid
Issue Date : 2020-12-15
Type : Chemical
Substance Number : 967
Moehs Group, a reference company in the production of pharmaceutical active ingredients.
Certificate Number : R1-CEP 1996-002 - Rev 06
Status : Valid
Issue Date : 2021-04-16
Type : Chemical
Substance Number : 967
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results] NDC API
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Listed Suppliers
Axplora is your partner of choice for complex APIs.
About the Company : Axplora, created from the merger of Farmabios, Novasep & PharmaZell, is a leading API manufacturing partner to the world’s leading pharma & biotech companies, delivering top-qual...
Transo-Pharm GmbH works globally to supply Active Pharmaceutical Ingredients adhering to the highest quality & GMP standards.
About the Company : Transo-Pharm, founded in 1987, is a fully licensed global distributor of pharmaceutical components for health and veterinary industries. It supports customers throughout the API li...
Basic Nutrition, your expert for sourcing from China, India and Europe.
About the Company : As an ISO9001, ISO22000 certificated supplier, Basic Nutrition supply high-quality ingredients for nutraceuticals. We can offer a range of products from small to large quantites: h...
Moehs Group, a reference company in the production of pharmaceutical active ingredients.
About the Company : Since 1962, MOEHS has produced high-quality Active Pharmaceutical Ingredients (APIs) for the global market. With decades of technical expertise, Moehs Group delivers pharmaceutical...
Pharm-Rx is a reputed global importer and distributor of pharmaceutical active ingredients.
About the Company : Established in 1991, Pharm-Rx is an importer and distributor of active ingredients serving the pharmaceutical, nutritional supplement, and food industries. The company follows a hi...
Willow Birch Pharma delivers trusted, high-quality APIs nationwide with unmatched service, compliance, and competitive value.
About the Company : Willow Birch Pharma, Inc. is a premier supplier of bulk APIs to North American Compounding Pharmacies, sourcing from FDA registered and GMP manufacturers. With licenses in all 50 s...
Anlon Healthcare manufactures high-quality Pharmaceutical Bulk Drugs & Intermediates compliant with FDA, PMDA, KFDA, cGMP & WHO-GMP.
About the Company : Anlon Healthcare is a research-focused pharmaceutical manufacturer based in Rajkot, specializing in bulk drugs and intermediates. The company’s products comply with international...
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Drugs in Development
Lead Product(s) : Acetylcysteine,Inapplicable
Therapeutic Area : Pharmacology/Toxicology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Glenmark Pharmaceuticals
Deal Size : Undisclosed
Deal Type : Acquisition
Glenmark Acquires & Launches Acetylcysteine Injection 6gm/30mL Single-Dose Vials
Details : Glenmark has acquired generic version of Acetadote (acetylcysteine) injection from Aspen Pharma. It is an antidote for acetaminophen overdose indicated to prevent or lessen hepatic injury.
Product Name : Acetadote-Generic
Product Type : Miscellaneous
Upfront Cash : Undisclosed
March 03, 2025
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FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]DRUG PRODUCT COMPOSITIONS
DOSAGE - TABLET, EFFERVESCENT;ORAL - 2.5GM
USFDA APPLICATION NUMBER - 207916
DOSAGE - TABLET, EFFERVESCENT;ORAL - 500MG
USFDA APPLICATION NUMBER - 207916
DOSAGE - INJECTABLE;INTRAVENOUS - 6GM/30ML (2...DOSAGE - INJECTABLE;INTRAVENOUS - 6GM/30ML (200MG/ML)
USFDA APPLICATION NUMBER - 21539
Digital Content
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REF. STANDARDS & IMPURITIES
ABOUT THIS PAGE
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PharmaCompass offers a list of Acetylcysteine 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 Acetylcysteine manufacturer or Acetylcysteine supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Acetylcysteine manufacturer or Acetylcysteine supplier.
A Brunac manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Brunac, including repackagers and relabelers. The FDA regulates Brunac manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Brunac 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 Brunac manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Brunac supplier is an individual or a company that provides Brunac active pharmaceutical ingredient (API) or Brunac finished formulations upon request. The Brunac suppliers may include Brunac API manufacturers, exporters, distributors and traders.
click here to find a list of Brunac suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Brunac DMF (Drug Master File) is a document detailing the whole manufacturing process of Brunac active pharmaceutical ingredient (API) in detail. Different forms of Brunac DMFs exist exist since differing nations have different regulations, such as Brunac USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Brunac DMF submitted to regulatory agencies in the US is known as a USDMF. Brunac USDMF includes data on Brunac's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Brunac USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Brunac 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 Brunac Drug Master File in Japan (Brunac JDMF) empowers Brunac 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 Brunac JDMF during the approval evaluation for pharmaceutical products. At the time of Brunac 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 Brunac 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 Brunac Drug Master File in Korea (Brunac KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Brunac. The MFDS reviews the Brunac KDMF as part of the drug registration process and uses the information provided in the Brunac KDMF to evaluate the safety and efficacy of the drug.
After submitting a Brunac 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 Brunac API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Brunac suppliers with KDMF on PharmaCompass.
A Brunac CEP of the European Pharmacopoeia monograph is often referred to as a Brunac Certificate of Suitability (COS). The purpose of a Brunac CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Brunac EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Brunac to their clients by showing that a Brunac CEP has been issued for it. The manufacturer submits a Brunac CEP (COS) as part of the market authorization procedure, and it takes on the role of a Brunac CEP holder for the record. Additionally, the data presented in the Brunac CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Brunac DMF.
A Brunac CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Brunac 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 Brunac suppliers with CEP (COS) 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 Brunac as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Brunac 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 Brunac 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 Brunac and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Brunac NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Brunac suppliers with NDC on PharmaCompass.
Brunac 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 Brunac GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Brunac GMP manufacturer or Brunac GMP API supplier for your needs.
A Brunac CoA (Certificate of Analysis) is a formal document that attests to Brunac's compliance with Brunac specifications and serves as a tool for batch-level quality control.
Brunac CoA mostly includes findings from lab analyses of a specific batch. For each Brunac 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.
Brunac may be tested according to a variety of international standards, such as European Pharmacopoeia (Brunac EP), Brunac JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Brunac USP).
