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LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
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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, ...
About the Company :
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API Imports and Exports
Drugs in Development
Lead Product(s) : Pilocarpine Hydrochloride
Therapeutic Area : Ophthalmology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : In the VIRGO trial evaluating twice-daily administration of VUITY (pilocarpine HCl ophthalmic solution), the primary endpoint of improving near vision without compromising distance vision at Day 14, Hour 9 was met.
Product Name : Vuity
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
May 04, 2022
Lead Product(s) : Pilocarpine Hydrochloride
Therapeutic Area : Ophthalmology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
VUITY™ (Pilocarpine HCI Ophthalmic Solution) 1.25%, the First and Only FDA-Approved Eye Drop to ...
Details : FDA approval of VUITY (Pilocarpine), is a once-daily prescription eye drop that improves near and intermediate vision without impacting distance vision for adults with age-related blurry near vision.
Product Name : Vuity
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
September 12, 2021
Lead Product(s) : Pilocarpine Hydrochloride
Therapeutic Area : Ophthalmology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : VUITY, an optimized formulation of pilocarpine, established eye care therapeutic, specifically designed to treat age-related blurry near vision. It is delivered with proprietary pHast™ technology, which allows VUITY to rapidly adjust to physiologic pH ...
Product Name : Vuity
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
April 28, 2022
Lead Product(s) : Pilocarpine Hydrochloride
Therapeutic Area : Ophthalmology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : VUITY is an optimized formulation of pilocarpine, an established eye care therapeutic, specifically designed to treat age-related blurry near vision. It is delivered with proprietary pHas technology, which allows VUITY to rapidly adjust to physiologic pH...
Product Name : Vuity
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
April 19, 2022
Lead Product(s) : Pilocarpine Hydrochloride
Therapeutic Area : Ophthalmology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
U.S. Food and Drug Administration Approves VUITY™ (Pilocarpine HCI Ophthalmic Solution) 1.25%, t...
Details : VUITY™ (pilocarpine HCL ophthalmic solution) 1.25% is a prescription eyedrop to treat age-related blurry near vision (presbyopia) in adults. VUITY to improve near and intermediate vision without impacting distance vision with one drop daily.
Product Name : Vuity
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
October 29, 2021
Lead Product(s) : Pilocarpine Hydrochloride
Therapeutic Area : Ophthalmology
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : AbbVie Inc
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : The company will present patient-reported outcomes for AGN-190584, an investigational therapy for the treatment of presbyopia. Recently the company submitted an NDA to the U.S. Food and Drug Administration based on data from the Phase 3 GEMINI 1 and GEMI...
Product Name : Vuity
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
April 27, 2021
Lead Product(s) : Pilocarpine Hydrochloride
Therapeutic Area : Ophthalmology
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : AbbVie Inc
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Allergan has submitted a New Drug Application to the U.S. Food and Drug Administration for investigational AGN-190584 (pilocarpine 1.25%) ophthalmic solution for the treatment of presbyopia. The FDA is expected to act on the NDA by the end of 2021.
Product Name : Vuity
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
February 25, 2021
Lead Product(s) : Pilocarpine Hydrochloride
Therapeutic Area : Ophthalmology
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : AbbVie Inc
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Phase 3 GEMINI 1 and 2 studies evaluating AGN-190584 (pilocarpine 1.25%) ophthalmic solution met the primary endpoint, reaching statistical significance in improvement in near vision.
Product Name : Vuity
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
October 28, 2020
Lead Product(s) : Pilocarpine Hydrochloride
Therapeutic Area : Ophthalmology
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Data presented at the meeting will include an analysis examining the safety and efficacy of DURYSTA™ and a second analysis of data from the Phase 3 ARTEMIS studies that identify different characteristics of glaucoma patients who may respond after being...
Product Name : Vuity
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
June 11, 2020
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Regulatory Info :
Registration Country : Italy
Brand Name : Pilocarpine Lux
Dosage Form :
Dosage Strength : Coll 10 Ml 2%
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Italy
Regulatory Info :
Registration Country : Italy
Brand Name : Pilocarpine Lux
Dosage Form :
Dosage Strength : Coll 10 Ml 1%
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Italy
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DOSAGE - SOLUTION;OPHTHALMIC - 1%
USFDA APPLICATION NUMBER - 200890
DOSAGE - SOLUTION;OPHTHALMIC - 2%
USFDA APPLICATION NUMBER - 200890
DOSAGE - SOLUTION;OPHTHALMIC - 4%
USFDA APPLICATION NUMBER - 200890
DOSAGE - TABLET;ORAL - 5MG
USFDA APPLICATION NUMBER - 20237
DOSAGE - TABLET;ORAL - 7.5MG
USFDA APPLICATION NUMBER - 20237
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Pfanstiehl, a global leader in the manufacture of cGMP high purity, low endotoxin, low metals (HPLE-LM)TM injectable grade excipients.
Dosage Form : Injectable / Parenteral
Grade : Parenteral
Application : Parenteral, Thickeners and Stabilizers
Excipient Details : Sucrose is used to stabilize proteins, lipids, carbohydrates, ADCs & vaccines. It is also used as a cryopreservative in cell-based bioprocesses.
Pharmacopoeia Ref : USP NF, EP, JP, ChP
Technical Specs : Low Endotoxin, Low Metals
Ingredient(s) : Sucrose
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REF. STANDARDS & IMPURITIES
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PharmaCompass offers a list of Pilocarpine Hydrochloride 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 Pilocarpine Hydrochloride manufacturer or Pilocarpine Hydrochloride supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Pilocarpine Hydrochloride manufacturer or Pilocarpine Hydrochloride supplier.
PharmaCompass also assists you with knowing the Pilocarpine Hydrochloride API Price utilized in the formulation of products. Pilocarpine Hydrochloride API Price is not always fixed or binding as the Pilocarpine Hydrochloride Price is obtained through a variety of data sources. The Pilocarpine Hydrochloride Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Pilocarpine Hydrochloride manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Pilocarpine Hydrochloride, including repackagers and relabelers. The FDA regulates Pilocarpine Hydrochloride manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Pilocarpine Hydrochloride 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 Pilocarpine Hydrochloride manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Pilocarpine Hydrochloride supplier is an individual or a company that provides Pilocarpine Hydrochloride active pharmaceutical ingredient (API) or Pilocarpine Hydrochloride finished formulations upon request. The Pilocarpine Hydrochloride suppliers may include Pilocarpine Hydrochloride API manufacturers, exporters, distributors and traders.
click here to find a list of Pilocarpine Hydrochloride suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Pilocarpine Hydrochloride DMF (Drug Master File) is a document detailing the whole manufacturing process of Pilocarpine Hydrochloride active pharmaceutical ingredient (API) in detail. Different forms of Pilocarpine Hydrochloride DMFs exist exist since differing nations have different regulations, such as Pilocarpine Hydrochloride USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Pilocarpine Hydrochloride DMF submitted to regulatory agencies in the US is known as a USDMF. Pilocarpine Hydrochloride USDMF includes data on Pilocarpine Hydrochloride's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Pilocarpine Hydrochloride USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Pilocarpine Hydrochloride 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 Pilocarpine Hydrochloride Drug Master File in Japan (Pilocarpine Hydrochloride JDMF) empowers Pilocarpine Hydrochloride 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 Pilocarpine Hydrochloride JDMF during the approval evaluation for pharmaceutical products. At the time of Pilocarpine Hydrochloride 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 Pilocarpine Hydrochloride 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 Pilocarpine Hydrochloride Drug Master File in Korea (Pilocarpine Hydrochloride KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Pilocarpine Hydrochloride. The MFDS reviews the Pilocarpine Hydrochloride KDMF as part of the drug registration process and uses the information provided in the Pilocarpine Hydrochloride KDMF to evaluate the safety and efficacy of the drug.
After submitting a Pilocarpine Hydrochloride 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 Pilocarpine Hydrochloride API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Pilocarpine Hydrochloride suppliers with KDMF on PharmaCompass.
A Pilocarpine Hydrochloride CEP of the European Pharmacopoeia monograph is often referred to as a Pilocarpine Hydrochloride Certificate of Suitability (COS). The purpose of a Pilocarpine Hydrochloride CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Pilocarpine Hydrochloride EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Pilocarpine Hydrochloride to their clients by showing that a Pilocarpine Hydrochloride CEP has been issued for it. The manufacturer submits a Pilocarpine Hydrochloride CEP (COS) as part of the market authorization procedure, and it takes on the role of a Pilocarpine Hydrochloride CEP holder for the record. Additionally, the data presented in the Pilocarpine Hydrochloride CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Pilocarpine Hydrochloride DMF.
A Pilocarpine Hydrochloride CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Pilocarpine Hydrochloride 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 Pilocarpine Hydrochloride 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 Pilocarpine Hydrochloride as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Pilocarpine Hydrochloride 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 Pilocarpine Hydrochloride 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 Pilocarpine Hydrochloride and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Pilocarpine Hydrochloride NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Pilocarpine Hydrochloride suppliers with NDC on PharmaCompass.
Pilocarpine Hydrochloride 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 Pilocarpine Hydrochloride 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 Pilocarpine Hydrochloride GMP manufacturer or Pilocarpine Hydrochloride GMP API supplier for your needs.
A Pilocarpine Hydrochloride CoA (Certificate of Analysis) is a formal document that attests to Pilocarpine Hydrochloride's compliance with Pilocarpine Hydrochloride specifications and serves as a tool for batch-level quality control.
Pilocarpine Hydrochloride CoA mostly includes findings from lab analyses of a specific batch. For each Pilocarpine Hydrochloride 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.
Pilocarpine Hydrochloride may be tested according to a variety of international standards, such as European Pharmacopoeia (Pilocarpine Hydrochloride EP), Pilocarpine Hydrochloride JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Pilocarpine Hydrochloride USP).
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