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Regulatory Info :
Registration Country : Italy
Bismuth Subcitrate Potassium; Metronidazole; Tetracycline Hydrochloride
Brand Name : Pylera
Dosage Form : Bismuth Oxide+Metronidazole+Tetracycline Hydrochloride 140+125+125Mg 120 Unita' Oral Use
Dosage Strength : 120 cps 140 mg + 125 mg + 125 mg
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Italy
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Gangwal Healthcare
Gangwal Healthcare is powered by innovation, driving health, wellness & healing.
Dosage Form : Tablet
Grade : Oral
Gangwal Healthcare is powered by innovation, driving health, wellness & healing.
Dosage Form : Tablet
Grade : Oral
Application : Fillers, Diluents & Binders
Excipient Details : Microlose (Lactose Monohydrate & Microcrystalline Cellulose) is used as a diluent in oral dosage forms such as tablets.
Pharmacopoeia Ref : USP-NF,BP,EP,IP
Technical Specs : Lactose Monohydrate – 40%, Microcrystalline cellulose – 60%
Ingredient(s) : Lactose Monohydrate
Gangwal Healthcare is powered by innovation, driving health, wellness & healing.
Dosage Form : Tablet
Grade : Oral
Application : Fillers, Diluents & Binders
Excipient Details : Starlose P40 (Starch & Lactose Monohydrate) is used as a diluent in oral dosage forms such as tablets.
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ABOUT THIS PAGE
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PharmaCompass offers a list of Bismuth Subcitrate Potassium 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 Bismuth Subcitrate Potassium manufacturer or Bismuth Subcitrate Potassium supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Bismuth Subcitrate Potassium manufacturer or Bismuth Subcitrate Potassium supplier.
A PYLERA manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of PYLERA, including repackagers and relabelers. The FDA regulates PYLERA manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. PYLERA 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 PYLERA manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A PYLERA supplier is an individual or a company that provides PYLERA active pharmaceutical ingredient (API) or PYLERA finished formulations upon request. The PYLERA suppliers may include PYLERA API manufacturers, exporters, distributors and traders.
click here to find a list of PYLERA suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A PYLERA DMF (Drug Master File) is a document detailing the whole manufacturing process of PYLERA active pharmaceutical ingredient (API) in detail. Different forms of PYLERA DMFs exist exist since differing nations have different regulations, such as PYLERA USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A PYLERA DMF submitted to regulatory agencies in the US is known as a USDMF. PYLERA USDMF includes data on PYLERA's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The PYLERA USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of PYLERA suppliers with USDMF 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 PYLERA as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for PYLERA 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 PYLERA 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 PYLERA and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a PYLERA NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of PYLERA suppliers with NDC on PharmaCompass.
PYLERA 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 PYLERA GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right PYLERA GMP manufacturer or PYLERA GMP API supplier for your needs.
A PYLERA CoA (Certificate of Analysis) is a formal document that attests to PYLERA's compliance with PYLERA specifications and serves as a tool for batch-level quality control.
PYLERA CoA mostly includes findings from lab analyses of a specific batch. For each PYLERA 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.
PYLERA may be tested according to a variety of international standards, such as European Pharmacopoeia (PYLERA EP), PYLERA JP (Japanese Pharmacopeia) and the US Pharmacopoeia (PYLERA USP).
