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API SUPPLIERS
Bal Pharma, leading manufacturer of niche & specialty API, Intermediates and Finished Formulations.
JDMF
EU-WC
KDMF
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
Metrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.
Rochem, your partner in developing, sourcing, and supplying pharmaceutical & animal health ingredients of Chinese origin.
Jai Radhe Sales is your partner for all your sourcing needs.
AMI Lifesciences is Driven by Chemistry. Powered by People.
HRV Global Life Sciences - Market Expansion Leader in Pharmaceuticals.
Harika Drugs has been providing a qualitative range of Bulk Drugs/ APIs since 1993.
SNJ Labs: WHO-GMP certified API leader in India, specializing in bulk drugs & intermediates with unmatched expertise.
Cosma S.p.A.: FDA-approved API manufacturing with 300+ tons capacity, serving pharma and animal health industries worldwide.
ASMF
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USDMF
Cosma S.p.A.: FDA-approved API manufacturing with 300+ tons capacity, serving pharma and animal health industries worldwide.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 25538
Submission : 2011-12-06
Status :
Type : II
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Bal Pharma, leading manufacturer of niche & specialty API, Intermediates and Finished Formulations.
Certificate Number : CEP 2013-039 - Rev 03
Status : Valid
Issue Date : 2025-06-23
Type : Chemical
Substance Number : 1524
Bal Pharma, leading manufacturer of niche & specialty API, Intermediates and Finished Formulations.
Certificate Number : CEP 2001-273 - Rev 07
Status : Valid
Issue Date : 2025-06-19
Type : Chemical
Substance Number : 1524
AMI Lifesciences is Driven by Chemistry. Powered by People.
Certificate Number : CEP 2021-465 - Rev 00
Status : Valid
Issue Date : 2024-02-15
Type : Chemical
Substance Number : 1524
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results] JDMF
Bal Pharma, leading manufacturer of niche & specialty API, Intermediates and Finished Formulations.
Registration Number : 220MF10140
Registrant's Address : 5th Floor, Lakshminarayan Complex, 10/1, Palace Road, Bangalore-560052, India
Initial Date of Registration : 2008-06-10
Latest Date of Registration : 2008-06-10
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]EU WC
Bal Pharma, leading manufacturer of niche & specialty API, Intermediates and Finished Formulations.
Date of Issue : 2022-08-25
Valid Till : 2025-07-02
Written Confirmation Number : WC-0156
Address of the Firm : 61-B, Bommasandra Industrial Area, Bengaluru-560 099, India
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]KDMF
Bal Pharma, leading manufacturer of niche & specialty API, Intermediates and Finished Formulations.
Registrant Name : Aging Life Science Co., Ltd.
Registration Date : 2005-08-31
Registration Number : 20050831-1-C-2-02
Manufacturer Name : BAL PHARMA LTD.
Manufacturer Address : Plot No. 61B, Bommasandra Industrial area, Hosur Road, Bangalore - 560 099, India
Bal Pharma, leading manufacturer of niche & specialty API, Intermediates and Finished Formulations.
Registrant Name : Aging Life Science Co., Ltd.
Registration Date : 2022-04-11
Registration Number : 20050831-1-C-2-02(1)
Manufacturer Name : Bal Pharma Limited.
Manufacturer Address : Plot No. 61B, Bommasandra Industrial Area, Hosur Road, Bangalore 560 099, 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
Bal Pharma, leading manufacturer of niche & specialty API, Intermediates and Finished Formulations.
About the Company : Bal Pharma is a leading Indian pharmaceutical company with 30+ years of experience, specializing in prescription drugs, generic and OTC products, intravenous infusions, and bulk ac...
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, ...
Metrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.
About the Company : Established in 2004, Metrochem API is one of the fastest-growing APIs, pellets & intermediates manufacturers. It has 6 dedicated manufacturing facilities for its 3 core product gro...
Rochem, your partner in developing, sourcing, and supplying pharmaceutical & animal health ingredients of Chinese origin.
About the Company : Established in 1994, Rochem is a distributor of pharmaceutical, food, nutritional and animal health ingredients to some of the largest companies in the world. It sources high-quali...
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 ...
AMI Lifesciences is Driven by Chemistry. Powered by People.
About the Company : Ami Lifesciences, established in 2006, is one of the fastest growing API manufacturing companies in India. Specializing in cardiovascular, anti-diabetic, CNS, and respiratory thera...
HRV Global Life Sciences - Market Expansion Leader in Pharmaceuticals.
About the Company : HRV Global is a leading global manufacturer, seller & exporter of a wide range of APIs, advanced intermediates, pellets, food grade chemicals, food additives & food ingredients. It...
Harika Drugs has been providing a qualitative range of Bulk Drugs/ APIs since 1993.
About the Company : Our endeavours also lie in the import, and domestic sourcing of raw materials from reliable vendors of the market. We have an excellent infrastructure with world class cGMP facilit...
SNJ Labs: WHO-GMP certified API leader in India, specializing in bulk drugs & intermediates with unmatched expertise.
About the Company : SNJ Labs Pvt. Ltd., established in 2013, has rapidly emerged as India’s largest manufacturer of Iron Sucrose, achieving a production capacity of 120 MT per year within just five ...
Cosma S.p.A.: FDA-approved API manufacturing with 300+ tons capacity, serving pharma and animal health industries worldwide.
About the Company : Cosma S.p.A., established in 1977 in Bergamo, northern Italy, is the largest manufacturing site within the CFM group, with a 130,000L (130 m³) glass-lined reaction volume and over...
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API/FDF Prices: Book a Demo to explore the features and consider upgrading later
API Imports and Exports
INTERMEDIATE SUPPLIERS
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Regulatory Info : Generic
Registration Country : South Africa
Brand Name : Glycron
Dosage Form : TAB
Dosage Strength : 80mg
Packaging : 60X1mg
Approval Date :
Application Number :
Regulatory Info : Generic
Registration Country : South Africa
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ABOUT THIS PAGE
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PharmaCompass offers a list of Gliclazide 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 Gliclazide manufacturer or Gliclazide supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Gliclazide manufacturer or Gliclazide supplier.
PharmaCompass also assists you with knowing the Gliclazide API Price utilized in the formulation of products. Gliclazide API Price is not always fixed or binding as the Gliclazide Price is obtained through a variety of data sources. The Gliclazide Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Gliclazide (JAN/INN) manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Gliclazide (JAN/INN), including repackagers and relabelers. The FDA regulates Gliclazide (JAN/INN) manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Gliclazide (JAN/INN) 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 Gliclazide (JAN/INN) manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Gliclazide (JAN/INN) supplier is an individual or a company that provides Gliclazide (JAN/INN) active pharmaceutical ingredient (API) or Gliclazide (JAN/INN) finished formulations upon request. The Gliclazide (JAN/INN) suppliers may include Gliclazide (JAN/INN) API manufacturers, exporters, distributors and traders.
click here to find a list of Gliclazide (JAN/INN) suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Gliclazide (JAN/INN) DMF (Drug Master File) is a document detailing the whole manufacturing process of Gliclazide (JAN/INN) active pharmaceutical ingredient (API) in detail. Different forms of Gliclazide (JAN/INN) DMFs exist exist since differing nations have different regulations, such as Gliclazide (JAN/INN) USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Gliclazide (JAN/INN) DMF submitted to regulatory agencies in the US is known as a USDMF. Gliclazide (JAN/INN) USDMF includes data on Gliclazide (JAN/INN)'s chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Gliclazide (JAN/INN) USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Gliclazide (JAN/INN) 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 Gliclazide (JAN/INN) Drug Master File in Japan (Gliclazide (JAN/INN) JDMF) empowers Gliclazide (JAN/INN) 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 Gliclazide (JAN/INN) JDMF during the approval evaluation for pharmaceutical products. At the time of Gliclazide (JAN/INN) 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 Gliclazide (JAN/INN) 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 Gliclazide (JAN/INN) Drug Master File in Korea (Gliclazide (JAN/INN) KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Gliclazide (JAN/INN). The MFDS reviews the Gliclazide (JAN/INN) KDMF as part of the drug registration process and uses the information provided in the Gliclazide (JAN/INN) KDMF to evaluate the safety and efficacy of the drug.
After submitting a Gliclazide (JAN/INN) 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 Gliclazide (JAN/INN) API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Gliclazide (JAN/INN) suppliers with KDMF on PharmaCompass.
A Gliclazide (JAN/INN) CEP of the European Pharmacopoeia monograph is often referred to as a Gliclazide (JAN/INN) Certificate of Suitability (COS). The purpose of a Gliclazide (JAN/INN) CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Gliclazide (JAN/INN) EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Gliclazide (JAN/INN) to their clients by showing that a Gliclazide (JAN/INN) CEP has been issued for it. The manufacturer submits a Gliclazide (JAN/INN) CEP (COS) as part of the market authorization procedure, and it takes on the role of a Gliclazide (JAN/INN) CEP holder for the record. Additionally, the data presented in the Gliclazide (JAN/INN) CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Gliclazide (JAN/INN) DMF.
A Gliclazide (JAN/INN) CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Gliclazide (JAN/INN) 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 Gliclazide (JAN/INN) suppliers with CEP (COS) on PharmaCompass.
A Gliclazide (JAN/INN) written confirmation (Gliclazide (JAN/INN) WC) is an official document issued by a regulatory agency to a Gliclazide (JAN/INN) manufacturer, verifying that the manufacturing facility of a Gliclazide (JAN/INN) active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Gliclazide (JAN/INN) APIs or Gliclazide (JAN/INN) finished pharmaceutical products to another nation, regulatory agencies frequently require a Gliclazide (JAN/INN) WC (written confirmation) as part of the regulatory process.
click here to find a list of Gliclazide (JAN/INN) 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 Gliclazide (JAN/INN) as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Gliclazide (JAN/INN) 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 Gliclazide (JAN/INN) 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 Gliclazide (JAN/INN) and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Gliclazide (JAN/INN) NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Gliclazide (JAN/INN) suppliers with NDC on PharmaCompass.
Gliclazide (JAN/INN) 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 Gliclazide (JAN/INN) 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 Gliclazide (JAN/INN) GMP manufacturer or Gliclazide (JAN/INN) GMP API supplier for your needs.
A Gliclazide (JAN/INN) CoA (Certificate of Analysis) is a formal document that attests to Gliclazide (JAN/INN)'s compliance with Gliclazide (JAN/INN) specifications and serves as a tool for batch-level quality control.
Gliclazide (JAN/INN) CoA mostly includes findings from lab analyses of a specific batch. For each Gliclazide (JAN/INN) 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.
Gliclazide (JAN/INN) may be tested according to a variety of international standards, such as European Pharmacopoeia (Gliclazide (JAN/INN) EP), Gliclazide (JAN/INN) JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Gliclazide (JAN/INN) USP).
