Synopsis
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DRUG PRODUCT COMPOSITIONS0
Weekly News Recap #Phispers
API SUPPLIERS
Inke S.A: APIs manufacturing plant.
Seqens is an integrated global leader in pharmaceutical solutions & specialty ingredients, & custom-made solutions to our customers.
SWATI - Transforming science into solutions with 60+ years of expertise, global accreditations, and pioneering biotech innovation.
Vamsi Labs is one of the major manufacturers of Anti-asthmatic, Anti-migraine & Anti-psychotic APIs.
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
Cohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.
Coral's API range includes Corticosteroids, Antihistamines. Hormones and Antineoplastics.
Jai Radhe Sales is your partner for all your sourcing needs.
NDC
ASMF
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USDMF
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SWATI - Transforming science into solutions with 60+ years of expertise, global accreditations, and pioneering biotech innovation.
Date of Issue : 2025-09-24
Valid Till : 2028-07-07
Written Confirmation Number : WC-0165
Address of the Firm : Plot No. A-1/2102 & 2103, Phase-III, G.I.D.C Vapi-396195, Valsad, Gujarat, India
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
Inke S.A: APIs manufacturing plant.
About the Company : Inke S.A., is focused since 1980 in the development and manufacture of the highest quality Active Pharmaceutical Ingredients (APIs) with complex synthesis processes for diverse the...
Seqens is an integrated global leader in pharmaceutical solutions & specialty ingredients, & custom-made solutions to our customers.
About the Company : Founded in 2003, Seqens has evolved into a global leader in pharmaceutical solutions and specialty ingredients. The company supports customers in the development, scale-up, and man...
SWATI - Transforming science into solutions with 60+ years of expertise, global accreditations, and pioneering biotech innovation.
About the Company : Swati Spentose Pvt. Ltd. (SSPL), part of the 60-year-old V Group, is a globally trusted pharmaceutical manufacturer supplying to 70+ countries. We specialize in high-quality APIs a...
Vamsi Labs is one of the major manufacturers of Anti-asthmatic, Anti-migraine & Anti-psychotic APIs.
About the Company : Vamsi Labs, established in 1991, is a leading Indian API manufacturer specializing in anti-asthmatic, anti-migraine, and anti-psychotic APIs for domestic and international markets ...
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
About the Company : LGM Pharma is a global leader in sourcing APIs, including hard-to-find drug substances, for pharmaceutical and biotech industries. LGM also operates as a full-service drug product ...
Cohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.
About the Company : Cohance Lifesciences is a leading CDMO and API platform delivering products and services across the full molecule lifecycle, from development to commercialization. With strong expe...
Coral's API range includes Corticosteroids, Antihistamines. Hormones and Antineoplastics.
About the Company : Coral Drugs is a research-based international pharmaceutical company with over 27 years of expertise in manufacturing high-quality, affordable APIs. Headquartered in Delhi, India, ...
Jai Radhe Sales is your partner for all your sourcing needs.
About the Company : Jai Radhe Sales, founded in 1999, is a global distributor specializing in high-quality pharmaceutical ingredients from India. It offers complete sourcing solutions, technical and r...
About the Company : AMSA S.p.A, founded in 1953 near Italy’s iconic Lake Como, is the founding manufacturing company of the CFM Group. With a modernized facility and over six decades of experience, ...
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Drugs in Development
Lead Product(s) : Indacaterol Maleate,Glycopyrronium Bromide
Therapeutic Area : Undisclosed
Highest Development Status : Phase I
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Indacaterol is a Other Small Molecule drug candidate, which is currently being evaluated in phase I clinical studies for the treatment of undefined medical condition.
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Inapplicable
March 18, 2022
Lead Product(s) : Indacaterol Maleate,Glycopyrronium Bromide,Ultibro Breezhaler,Carbon
Therapeutic Area : Undisclosed
Highest Development Status : Phase I
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Absorption of Indacaterol and Glycopyrronium From Ultibro Breezhaler
Details : Indacaterol Maleate is a Other Small Molecule drug candidate, which is currently being evaluated in phase I clinical studies for the treatment of undefined medical condition.
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Inapplicable
April 22, 2021
Lead Product(s) : Indacaterol Acetate,Glycopyrronium Bromide,Mometasone Furoate
Therapeutic Area : Pulmonary/Respiratory Diseases
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Novartis Pharmaceuticals Corporation
Deal Size : Inapplicable
Deal Type : Inapplicable
QVM149 Receives Regulatory Approval in Europe and Japan
Details : QVM149 combines the bronchodilation of indacaterol acetate (a LABA) and the antimuscarinic effects of glycopyrronium bromide (a LAMA) with mometasone furoate in a precise once-daily formulation, delivered via the dose-confirming Breezhaler® device.
Product Name : Enerzair Breezhaler
Product Type : Miscellaneous
Upfront Cash : Inapplicable
July 07, 2020
Lead Product(s) : Glycopyrronium Bromide,Inapplicable
Therapeutic Area : Neurology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Granules India Gets USFDA Nod for Generic Glycopyrrolate Oral Solution
Details : Cuvposa is an anticholinergic indicated to reduce chronic severe drooling in patients aged 3-16 years with neurologic conditions associated with problem drooling.
Product Name : Cuvposa-Generic
Product Type : Miscellaneous
Upfront Cash : Inapplicable
August 20, 2024
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]INTERMEDIATE SUPPLIERS
Alkaloids Private Limited: WHO-GMP, USFDA, EU-GMP & ISO compliant phyto and synthetic APIs.
CAS Number : 13220-33-2
End Use API : Glycopyrronium Bromide
About The Company : Alkaloids is a trusted manufacturer of phyto-based APIs and standardized botanical extracts, with expertise dating back to 1992. With decades of experience in n...
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DOSAGE - TABLET;ORAL - 1MG
USFDA APPLICATION NUMBER - 12827
DOSAGE - TABLET;ORAL - 2MG
USFDA APPLICATION NUMBER - 12827
DOSAGE - INJECTABLE;INJECTION - 0.2MG/ML
USFDA APPLICATION NUMBER - 17558
DOSAGE - POWDER;INHALATION - 15.6MCG/INH
USFDA APPLICATION NUMBER - 207923
DOSAGE - POWDER;INHALATION - 15.6MCG/INH;27.5...DOSAGE - POWDER;INHALATION - 15.6MCG/INH;27.5MCG/INH
USFDA APPLICATION NUMBER - 207930
DOSAGE - SOLUTION;INHALATION - 25MCG/ML
USFDA APPLICATION NUMBER - 208437
DOSAGE - TABLET, ORALLY DISINTEGRATING;ORAL -...DOSAGE - TABLET, ORALLY DISINTEGRATING;ORAL - 1.7MG
USFDA APPLICATION NUMBER - 215019
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REF. STANDARDS & IMPURITIES
ABOUT THIS PAGE
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PharmaCompass offers a list of Glycopyrronium Bromide 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 Glycopyrronium Bromide manufacturer or Glycopyrronium Bromide supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Glycopyrronium Bromide manufacturer or Glycopyrronium Bromide supplier.
A ROBINUL FORTE manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of ROBINUL FORTE, including repackagers and relabelers. The FDA regulates ROBINUL FORTE manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. ROBINUL FORTE 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 ROBINUL FORTE manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A ROBINUL FORTE supplier is an individual or a company that provides ROBINUL FORTE active pharmaceutical ingredient (API) or ROBINUL FORTE finished formulations upon request. The ROBINUL FORTE suppliers may include ROBINUL FORTE API manufacturers, exporters, distributors and traders.
click here to find a list of ROBINUL FORTE suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A ROBINUL FORTE DMF (Drug Master File) is a document detailing the whole manufacturing process of ROBINUL FORTE active pharmaceutical ingredient (API) in detail. Different forms of ROBINUL FORTE DMFs exist exist since differing nations have different regulations, such as ROBINUL FORTE USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A ROBINUL FORTE DMF submitted to regulatory agencies in the US is known as a USDMF. ROBINUL FORTE USDMF includes data on ROBINUL FORTE's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The ROBINUL FORTE USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of ROBINUL FORTE 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 ROBINUL FORTE Drug Master File in Japan (ROBINUL FORTE JDMF) empowers ROBINUL FORTE 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 ROBINUL FORTE JDMF during the approval evaluation for pharmaceutical products. At the time of ROBINUL FORTE 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 ROBINUL FORTE 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 ROBINUL FORTE Drug Master File in Korea (ROBINUL FORTE KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of ROBINUL FORTE. The MFDS reviews the ROBINUL FORTE KDMF as part of the drug registration process and uses the information provided in the ROBINUL FORTE KDMF to evaluate the safety and efficacy of the drug.
After submitting a ROBINUL FORTE 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 ROBINUL FORTE API can apply through the Korea Drug Master File (KDMF).
click here to find a list of ROBINUL FORTE suppliers with KDMF on PharmaCompass.
A ROBINUL FORTE CEP of the European Pharmacopoeia monograph is often referred to as a ROBINUL FORTE Certificate of Suitability (COS). The purpose of a ROBINUL FORTE CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of ROBINUL FORTE EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of ROBINUL FORTE to their clients by showing that a ROBINUL FORTE CEP has been issued for it. The manufacturer submits a ROBINUL FORTE CEP (COS) as part of the market authorization procedure, and it takes on the role of a ROBINUL FORTE CEP holder for the record. Additionally, the data presented in the ROBINUL FORTE CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the ROBINUL FORTE DMF.
A ROBINUL FORTE CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. ROBINUL FORTE 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 ROBINUL FORTE suppliers with CEP (COS) on PharmaCompass.
A ROBINUL FORTE written confirmation (ROBINUL FORTE WC) is an official document issued by a regulatory agency to a ROBINUL FORTE manufacturer, verifying that the manufacturing facility of a ROBINUL FORTE active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting ROBINUL FORTE APIs or ROBINUL FORTE finished pharmaceutical products to another nation, regulatory agencies frequently require a ROBINUL FORTE WC (written confirmation) as part of the regulatory process.
click here to find a list of ROBINUL FORTE 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 ROBINUL FORTE as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for ROBINUL FORTE 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 ROBINUL FORTE 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 ROBINUL FORTE and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a ROBINUL FORTE NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of ROBINUL FORTE suppliers with NDC on PharmaCompass.
ROBINUL FORTE 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 ROBINUL FORTE GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right ROBINUL FORTE GMP manufacturer or ROBINUL FORTE GMP API supplier for your needs.
A ROBINUL FORTE CoA (Certificate of Analysis) is a formal document that attests to ROBINUL FORTE's compliance with ROBINUL FORTE specifications and serves as a tool for batch-level quality control.
ROBINUL FORTE CoA mostly includes findings from lab analyses of a specific batch. For each ROBINUL FORTE 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.
ROBINUL FORTE may be tested according to a variety of international standards, such as European Pharmacopoeia (ROBINUL FORTE EP), ROBINUL FORTE JP (Japanese Pharmacopeia) and the US Pharmacopoeia (ROBINUL FORTE USP).
