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API SUPPLIERS
Zach System is committed to providing Highly Customized Solutions for all your Development Programs.
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KDMF
ASMF
Axplora is your partner of choice for complex APIs.
NDC
EU
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
Emay Pharmaceuticals is a GMP-certified API manufacturing company.
Gonane has API manufacturing expertise in new-age Corticosteroids, Hormones and other pharma raw materials.
Aarti Pharmalabs is a partner of choice for pharmaceutical companies for APIs & Intermediates. Largest Indian producer of Caffeine.
Bhavna Laboratories is an API & Intermediate manufacturer focusing on the muscle relaxant & ophthalmic segments.
Willow Birch Pharma delivers trusted, high-quality APIs nationwide with unmatched service, compliance, and competitive value.
Axplora is your partner of choice for complex APIs.
NDC
EU
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USDMF
Zach System is committed to providing Highly Customized Solutions for all your Development Programs.
GDUFA
DMF Review : Complete
Rev. Date : 2024-10-16
Pay. Date : 2024-10-08
DMF Number : 11105
Submission : 1994-09-26
Status :
Type : II
Axplora is your partner of choice for complex APIs.
GDUFA
DMF Review : Complete
Rev. Date : 2023-07-05
Pay. Date : 2023-01-24
DMF Number : 27717
Submission : 2013-11-11
Status :
Type : II
Axplora is your partner of choice for complex APIs.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 26937
Submission : 2013-03-05
Status :
Type : II
Aarti Pharmalabs is a partner of choice for pharmaceutical companies for APIs & Intermediates. Largest Indian producer of Caffeine.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 26249
Submission : 2012-07-26
Status :
Type : II
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]EU WC
Aarti Pharmalabs is a partner of choice for pharmaceutical companies for APIs & Intermediates. Largest Indian producer of Caffeine.
Date of Issue : 2025-08-22
Valid Till : 2028-08-21
Written Confirmation Number : WC-0099
Address of the Firm : Plot No.E-50, 50/1 and 59/1, Unit-IV, MIDC, Tarapur-401506, Taluka: Palghar, Dis...
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]KDMF
Zach System is committed to providing Highly Customized Solutions for all your Development Programs.
Registrant Name : Bashu Health Korea Co., Ltd.
Registration Date : 2008-05-07
Registration Number : 4063-1-ND
Manufacturer Name : Zach system
Manufacturer Address : Zone Industrielle La Croix Cadeau Avrille, 49240, France
Aarti Pharmalabs is a partner of choice for pharmaceutical companies for APIs & Intermediates. Largest Indian producer of Caffeine.
Registrant Name : Ace Biopharm Co., Ltd.
Registration Date : 2024-03-14
Registration Number : Su289-18-ND
Manufacturer Name : Aarti Pharmalabs Limited
Manufacturer Address : Plot No. E–50, 50/1 & 59/1, Unit-IV, MIDC, Tarapur, Taluka & District-Palghar, 401 ...
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]NDC API
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Zach System is committed to providing Highly Customized Solutions for all your Development Programs.
About the Company : Zach System, a subsidiary of Zambon Company, provides Active Pharmaceutical Ingredients (APIs), intermediates, and custom synthesis services aligned with customer timelines and bud...
Axplora is your partner of choice for complex APIs.
About the Company : Axplora, created from the merger of Farmabios, Novasep & PharmaZell, is a leading API manufacturing partner to the world’s leading pharma & biotech companies, delivering top-qual...
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 pharmaceutical and biotech industries. LGM also operates as a full-service CDMO, offering formulat...
Emay Pharmaceuticals is a GMP-certified API manufacturing company.
About the Company : Emay Pharmaceuticals Pvt Ltd operates as the merchant export division of M/s. Bhavna Laboratories Pvt Ltd. The company is a GMP-approved API manufacturer with over three decades of...
Gonane has API manufacturing expertise in new-age Corticosteroids, Hormones and other pharma raw materials.
About the Company : Gonane Pharma is a contract pharmaceutical company based in Gujarat, India, specializing in the manufacturing and marketing of corticosteroids, hormones, antivirals, and oncology p...
Aarti Pharmalabs is a partner of choice for pharmaceutical companies for APIs & Intermediates. Largest Indian producer of Caffeine.
About the Company : Aarti Pharmalabs is generic APIs & Intermediates manufacturing company & small molecule drug substance CDMO and the largest Indian manufacturer of Xanthine Derivatives (Caffeine, e...
Bhavna Laboratories is an API & Intermediate manufacturer focusing on the muscle relaxant & ophthalmic segments.
About the Company : Bhavna Laboratories Pvt. Ltd., founded in 1986, is an Indian manufacturer of APIs and intermediates. The company is approved by the FDA of India and holds cGMP certification for it...
Willow Birch Pharma delivers trusted, high-quality APIs nationwide with unmatched service, compliance, and competitive value.
About the Company : Willow Birch Pharma, Inc. is a premier supplier of bulk APIs to North American Compounding Pharmacies, sourcing from FDA registered and GMP manufacturers. With licenses in all 50 s...
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API Imports and Exports
Drugs in Development
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DOSAGE - OINTMENT;OPHTHALMIC - 0.5%
USFDA APPLICATION NUMBER - 200738
DOSAGE - GEL;OPHTHALMIC - 0.38%
USFDA APPLICATION NUMBER - 208219
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EUROAPI, the leading small molecules API player, provides both API sales & CDMO services.
Dosage Form : Tablet
Grade : Oral
EUROAPI, the leading small molecules API player, provides both API sales & CDMO services.
Dosage Form : Cream / Lotion / Ointment
Grade : Topical, Parenteral
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89
PharmaCompass offers a list of Loteprednol Etabonate 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 Loteprednol Etabonate manufacturer or Loteprednol Etabonate supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Loteprednol Etabonate manufacturer or Loteprednol Etabonate supplier.
PharmaCompass also assists you with knowing the Loteprednol Etabonate API Price utilized in the formulation of products. Loteprednol Etabonate API Price is not always fixed or binding as the Loteprednol Etabonate Price is obtained through a variety of data sources. The Loteprednol Etabonate Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A LOTEPREDNOL ESTABONATE manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of LOTEPREDNOL ESTABONATE, including repackagers and relabelers. The FDA regulates LOTEPREDNOL ESTABONATE manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. LOTEPREDNOL ESTABONATE 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 LOTEPREDNOL ESTABONATE manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A LOTEPREDNOL ESTABONATE supplier is an individual or a company that provides LOTEPREDNOL ESTABONATE active pharmaceutical ingredient (API) or LOTEPREDNOL ESTABONATE finished formulations upon request. The LOTEPREDNOL ESTABONATE suppliers may include LOTEPREDNOL ESTABONATE API manufacturers, exporters, distributors and traders.
click here to find a list of LOTEPREDNOL ESTABONATE suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A LOTEPREDNOL ESTABONATE DMF (Drug Master File) is a document detailing the whole manufacturing process of LOTEPREDNOL ESTABONATE active pharmaceutical ingredient (API) in detail. Different forms of LOTEPREDNOL ESTABONATE DMFs exist exist since differing nations have different regulations, such as LOTEPREDNOL ESTABONATE USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A LOTEPREDNOL ESTABONATE DMF submitted to regulatory agencies in the US is known as a USDMF. LOTEPREDNOL ESTABONATE USDMF includes data on LOTEPREDNOL ESTABONATE's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The LOTEPREDNOL ESTABONATE USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of LOTEPREDNOL ESTABONATE suppliers with USDMF 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 LOTEPREDNOL ESTABONATE Drug Master File in Korea (LOTEPREDNOL ESTABONATE KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of LOTEPREDNOL ESTABONATE. The MFDS reviews the LOTEPREDNOL ESTABONATE KDMF as part of the drug registration process and uses the information provided in the LOTEPREDNOL ESTABONATE KDMF to evaluate the safety and efficacy of the drug.
After submitting a LOTEPREDNOL ESTABONATE 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 LOTEPREDNOL ESTABONATE API can apply through the Korea Drug Master File (KDMF).
click here to find a list of LOTEPREDNOL ESTABONATE suppliers with KDMF on PharmaCompass.
A LOTEPREDNOL ESTABONATE written confirmation (LOTEPREDNOL ESTABONATE WC) is an official document issued by a regulatory agency to a LOTEPREDNOL ESTABONATE manufacturer, verifying that the manufacturing facility of a LOTEPREDNOL ESTABONATE active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting LOTEPREDNOL ESTABONATE APIs or LOTEPREDNOL ESTABONATE finished pharmaceutical products to another nation, regulatory agencies frequently require a LOTEPREDNOL ESTABONATE WC (written confirmation) as part of the regulatory process.
click here to find a list of LOTEPREDNOL ESTABONATE 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 LOTEPREDNOL ESTABONATE as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for LOTEPREDNOL ESTABONATE 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 LOTEPREDNOL ESTABONATE 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 LOTEPREDNOL ESTABONATE and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a LOTEPREDNOL ESTABONATE NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of LOTEPREDNOL ESTABONATE suppliers with NDC on PharmaCompass.
LOTEPREDNOL ESTABONATE 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 LOTEPREDNOL ESTABONATE 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 LOTEPREDNOL ESTABONATE GMP manufacturer or LOTEPREDNOL ESTABONATE GMP API supplier for your needs.
A LOTEPREDNOL ESTABONATE CoA (Certificate of Analysis) is a formal document that attests to LOTEPREDNOL ESTABONATE's compliance with LOTEPREDNOL ESTABONATE specifications and serves as a tool for batch-level quality control.
LOTEPREDNOL ESTABONATE CoA mostly includes findings from lab analyses of a specific batch. For each LOTEPREDNOL ESTABONATE 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.
LOTEPREDNOL ESTABONATE may be tested according to a variety of international standards, such as European Pharmacopoeia (LOTEPREDNOL ESTABONATE EP), LOTEPREDNOL ESTABONATE JP (Japanese Pharmacopeia) and the US Pharmacopoeia (LOTEPREDNOL ESTABONATE USP).
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