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USDMF
Inke S.A: APIs manufacturing plant.
GDUFA
DMF Review : Complete
Rev. Date : 2018-02-16
Pay. Date : 2017-07-06
DMF Number : 31836
Submission : 2017-07-22
Status :
Type : II
Seqens is an integrated global leader in pharmaceutical solutions & specialty ingredients & provides custom-made solutions.
GDUFA
DMF Review : Complete
Rev. Date : 2013-10-05
Pay. Date : 2013-09-30
DMF Number : 18106
Submission : 2005-02-22
Status :
Type : II
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Inke S.A: APIs manufacturing plant.
Glycopyrronium Bromide, Micronised, Non-micronis...
Certificate Number : R1-CEP 2017-182 - Rev 00
Status : Valid
Issue Date : 2023-08-17
Type : Chemical
Substance Number : 1783
Seqens is an integrated global leader in pharmaceutical solutions & specialty ingredients & provides custom-made solutions.
Certificate Number : R1-CEP 2012-129 - Rev 01
Status : Valid
Issue Date : 2020-07-30
Type : Chemical
Substance Number : 1783
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Seqens is an integrated global leader in pharmaceutical solutions & specialty ingredients & provides custom-made solutions.
Glycopyrronium bromide "For manufacturing purposes only"
Registration Number : 230MF10066
Registrant's Address : 21,chemin de la Sauvegarde 21 Ecully Parc - CS 33167 69134 Ecully Cedex France
Initial Date of Registration : 2018-05-21
Latest Date of Registration : 2019-05-07
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Inke S.A: APIs manufacturing plant.
Registrant Name : Samoh Pharmaceutical Co., Ltd.
Registration Date : 2020-11-03
Registration Number : 20201103-211-J-782
Manufacturer Name : INKE SA
Manufacturer Address : C/Argent 1, Area Industrial del Llobregat 08755 Castellbisbal Barcelona, Spain
Seqens is an integrated global leader in pharmaceutical solutions & specialty ingredients & provides custom-made solutions.
Registrant Name : BC World Healthcare Co., Ltd.
Registration Date : 2024-10-07
Registration Number : 20241007-211-J-1701
Manufacturer Name : PCAS Finland Oy
Manufacturer Address : Messukentankatu 8 FI-20210 Turku, Finland
Registrant Name : AstraZeneca Korea Ltd.
Registration Date : 2021-07-05
Registration Number : 20210705-211-J-1053
Manufacturer Name : PCAS Finland Oy@AstraZeneca ...
Manufacturer Address : Messukentankatu 8, 20210 Turku, Finland@Forskargatan 18, Sodertalje, 151 36, Sweden
Registrant Name : AstraZeneca Korea Ltd.
Registration Date : 2022-09-08
Registration Number : 20220908-211-J-1360
Manufacturer Name : PCAS Finland Oy@AstraZeneca ...
Manufacturer Address : Messukentankatu 8, 20210 Turku, Finland@200 Cardinal Way Redwood City, CA 94063 USA
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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 & provides custom-made solutions.
About the Company : Since its inception in 2003, Seqens has grown to become a global leader in pharmaceutical solutions and specialty ingredients. Seqens supports its customers in developing, scaling ...
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, ...
Jai Radhe Sales is your partner for all your sourcing needs.
About the Company : Jai Radhe Sales was founded in 1999 as an out-of-the-box distribution firm specializing in the global supply of high-quality pharmaceutical ingredients. The firm provides complete ...
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 & anti-psychotic APIs, it caters to domestic & international ma...
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API Imports and Exports
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Drugs in Development
Lead Product(s) : Indacaterol Acetate,Glycopyrronium Bromide,Mometasone Furoate
Therapeutic Area : Pulmonary/Respiratory Diseases
Highest Development Status : Approved
Partner/Sponsor/Collaborator : Novartis Pharmaceuticals Corporation
Deal Size : Not Applicable
Deal Type : Not Applicable
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.
Brand Name : Enerzair Breezhaler
Molecule Type : Small molecule
Upfront Cash : Not Applicable
July 07, 2020
Lead Product(s) : Glycopyrronium Bromide
Therapeutic Area : Neurology
Highest Development Status : Approved
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
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.
Brand Name : Cuvposa-Generic
Molecule Type : Small molecule
Upfront Cash : Not Applicable
August 20, 2024
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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 **Fe...DOSAGE - INJECTABLE;INJECTION - 0.2MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
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
A Glycopyrrolate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Glycopyrrolate, including repackagers and relabelers. The FDA regulates Glycopyrrolate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Glycopyrrolate 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 Glycopyrrolate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Glycopyrrolate supplier is an individual or a company that provides Glycopyrrolate active pharmaceutical ingredient (API) or Glycopyrrolate finished formulations upon request. The Glycopyrrolate suppliers may include Glycopyrrolate API manufacturers, exporters, distributors and traders.
click here to find a list of Glycopyrrolate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Glycopyrrolate DMF (Drug Master File) is a document detailing the whole manufacturing process of Glycopyrrolate active pharmaceutical ingredient (API) in detail. Different forms of Glycopyrrolate DMFs exist exist since differing nations have different regulations, such as Glycopyrrolate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Glycopyrrolate DMF submitted to regulatory agencies in the US is known as a USDMF. Glycopyrrolate USDMF includes data on Glycopyrrolate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Glycopyrrolate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Glycopyrrolate 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 Glycopyrrolate Drug Master File in Japan (Glycopyrrolate JDMF) empowers Glycopyrrolate 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 Glycopyrrolate JDMF during the approval evaluation for pharmaceutical products. At the time of Glycopyrrolate 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 Glycopyrrolate 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 Glycopyrrolate Drug Master File in Korea (Glycopyrrolate KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Glycopyrrolate. The MFDS reviews the Glycopyrrolate KDMF as part of the drug registration process and uses the information provided in the Glycopyrrolate KDMF to evaluate the safety and efficacy of the drug.
After submitting a Glycopyrrolate 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 Glycopyrrolate API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Glycopyrrolate suppliers with KDMF on PharmaCompass.
A Glycopyrrolate CEP of the European Pharmacopoeia monograph is often referred to as a Glycopyrrolate Certificate of Suitability (COS). The purpose of a Glycopyrrolate CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Glycopyrrolate EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Glycopyrrolate to their clients by showing that a Glycopyrrolate CEP has been issued for it. The manufacturer submits a Glycopyrrolate CEP (COS) as part of the market authorization procedure, and it takes on the role of a Glycopyrrolate CEP holder for the record. Additionally, the data presented in the Glycopyrrolate CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Glycopyrrolate DMF.
A Glycopyrrolate CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Glycopyrrolate 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 Glycopyrrolate suppliers with CEP (COS) on PharmaCompass.
A Glycopyrrolate written confirmation (Glycopyrrolate WC) is an official document issued by a regulatory agency to a Glycopyrrolate manufacturer, verifying that the manufacturing facility of a Glycopyrrolate active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Glycopyrrolate APIs or Glycopyrrolate finished pharmaceutical products to another nation, regulatory agencies frequently require a Glycopyrrolate WC (written confirmation) as part of the regulatory process.
click here to find a list of Glycopyrrolate 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 Glycopyrrolate as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Glycopyrrolate 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 Glycopyrrolate 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 Glycopyrrolate and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Glycopyrrolate NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Glycopyrrolate suppliers with NDC on PharmaCompass.
Glycopyrrolate 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 Glycopyrrolate 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 Glycopyrrolate GMP manufacturer or Glycopyrrolate GMP API supplier for your needs.
A Glycopyrrolate CoA (Certificate of Analysis) is a formal document that attests to Glycopyrrolate's compliance with Glycopyrrolate specifications and serves as a tool for batch-level quality control.
Glycopyrrolate CoA mostly includes findings from lab analyses of a specific batch. For each Glycopyrrolate 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.
Glycopyrrolate may be tested according to a variety of international standards, such as European Pharmacopoeia (Glycopyrrolate EP), Glycopyrrolate JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Glycopyrrolate USP).
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