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API SUPPLIERS
Seqens is an integrated global leader in pharmaceutical solutions & specialty ingredients, & custom-made solutions to our customers.
Bhavna Laboratories is an API & Intermediate manufacturer focusing on the muscle relaxant & ophthalmic segments.
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
Jai Radhe Sales is your partner for all your sourcing needs.
HRV Pharma - Market Expansion Leader in Pharmaceuticals.
Tenatra connects Indian manufacturers with global buyers through active partners in Germany, Switzerland, Belgium, Spain & Turkey.
Zeon Pharma is a manufacturer and supplier of APIs & Intermediates.
Together we can improve the quality of life
Curia - Accelerating therapies from discovery to commercialization with flexible, scalable CDMO solutions.
JDMF 
NDC
KDMF
Curia - Accelerating therapies from discovery to commercialization with flexible, scalable CDMO solutions.
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USDMF
Seqens is an integrated global leader in pharmaceutical solutions & specialty ingredients, & custom-made solutions to our customers.
GDUFA
DMF Review : Complete
Rev. Date : 2013-02-07
Pay. Date : 2013-01-02
DMF Number : 23908
Submission : 2010-06-18
Status :
Type : II
Curia - Accelerating therapies from discovery to commercialization with flexible, scalable CDMO solutions.
GDUFA
DMF Review : Complete
Rev. Date : 2013-06-25
Pay. Date : 2012-12-24
DMF Number : 25044
Submission : 2011-06-13
Status :
Type : II
Curia - Accelerating therapies from discovery to commercialization with flexible, scalable CDMO solutions.
GDUFA
DMF Review : Complete
Rev. Date : 2016-03-02
Pay. Date : 2016-02-12
DMF Number : 19526
Submission : 2006-06-14
Status :
Type : II
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]JDMF
Curia - Accelerating therapies from discovery to commercialization with flexible, scalable CDMO solutions.
Registration Number : 305MF10136
Registrant's Address : Parque Tecnologico-Parcela 105 Boecillo (Valladolid) Spain
Initial Date of Registration : 2023-12-19
Latest Date of Registration : 2023-12-19
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Curia - Accelerating therapies from discovery to commercialization with flexible, scalable CDMO solutions.
Registrant Name : Goodwills Co., Ltd.
Registration Date : 2021-04-28
Registration Number : 20210428-209-J-960
Manufacturer Name : Curia Spain SAU
Manufacturer Address : Parque Tecnológico Boecillo, Parcelas 2y 3, Boecillo, 47151 Valladolid, Spain
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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...
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...
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 ...
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...
HRV Pharma - Market Expansion Leader in Pharmaceuticals.
About the Company : HRV Pharma is a global manufacturer, seller, and exporter of APIs, intermediates, pellets, food-grade chemicals, food additives, and food ingredients. The company provides sourcing...
Tenatra connects Indian manufacturers with global buyers through active partners in Germany, Switzerland, Belgium, Spain & Turkey.
About the Company : Tenatra International was established as a proprietorship firm in 1999. It got off to a very good start, supporting clients in the United States, Mexico and Europe. As business opp...
Zeon Pharma is a manufacturer and supplier of APIs & Intermediates.
About the Company : Zeon Pharma Industries India Pvt. Ltd. is an ISO 9001:2015, cGMP, and WHO-GMP certified company with a dedicated manufacturing facility for Bulk Drugs (APIs), phytochemicals, herba...
Together we can improve the quality of life
About the Company : Shamrock Pharmachemi Pvt Ltd. is a globally recognized API leader with 26+ years in human and veterinary pharmaceuticals. Operating in 40+ countries, it owns two Gujarat facilities...
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Drugs in Development
Lead Product(s) : Olopatadine Hydrochloride,Inapplicable
Therapeutic Area : Ophthalmology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Dr. Reddy’s Launches Olopatadine Hydrochloride Ophthalmic Solution in the U.S.
Details : Olopatadine HCl, a miscellaneous product targeting the Histamine H1 receptor, shows promise in relieving itchy eyes.
Product Name : Pataday-Generic
Product Type : Miscellaneous
Upfront Cash : Inapplicable
January 14, 2026
Lead Product(s) : Olopatadine Hydrochloride,Inapplicable
Therapeutic Area : Ophthalmology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Dr. Reddy’s has launched of over-the-counter Olopatadine Hydrochloride Ophthalmic Solution USP, 0.2% and 0.1%, the storebrand equivalents of Pataday® Once Daily Relief and Pataday® Twice Daily Relief, in the U.S. market, as approved by the USFDA.
Product Name : Pataday-Generic
Product Type : Miscellaneous
Upfront Cash : Inapplicable
September 17, 2020
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]INTERMEDIATE SUPPLIERS
Bhavna Laboratories is an API & Intermediate manufacturer focusing on the muscle relaxant & ophthalmic segments.
(3-(Dimethylamino)propyl)triphenylphosphonium brom...
CAS Number : 27710-82-3
End Use API : Olopatadine Hydrochloride
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 ...
Bhavna Laboratories is an API & Intermediate manufacturer focusing on the muscle relaxant & ophthalmic segments.
Isoxepac [(11-Oxo-6,11-dihydrodibenzo[b,e]oxepin-2...
CAS Number : 55453-87-7
End Use API : Olopatadine Hydrochloride
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 ...
Tagoor's product development expertise, backed by our comprehensive understanding of the processes, helps us offer high-quality APIs.
CAS Number : 2971-79-1
End Use API : Olopatadine Hydrochloride
About The Company : Tagoor Laboratories, established in 2018 and part of the Tagoor Group, provides APIs, advanced intermediates, and key starting materials for critical and high-g...
Indian Drugs & Chemicals – delivering trusted APIs, intermediates & fine chemicals worldwide with 40+ years of quality expertise.
(3-(dimethylamino)propyl)triphenyl phosphonium bro...
CAS Number : 3934-20-1
End Use API : Olopatadine Hydrochloride
About The Company : Indian Drugs And Chemicals supplies quality products using modern technologies, supported by strong industry expertise. The company serves global markets with a...
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FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]DRUG PRODUCT COMPOSITIONS
DOSAGE - SOLUTION/DROPS;OPHTHALMIC - EQ 0.7% ...DOSAGE - SOLUTION/DROPS;OPHTHALMIC - EQ 0.7% BASE
USFDA APPLICATION NUMBER - 206276
DOSAGE - SOLUTION/DROPS;OPHTHALMIC - EQ 0.1% ...DOSAGE - SOLUTION/DROPS;OPHTHALMIC - EQ 0.1% BASE
USFDA APPLICATION NUMBER - 20688
DOSAGE - SOLUTION/DROPS;OPHTHALMIC - EQ 0.2% ...DOSAGE - SOLUTION/DROPS;OPHTHALMIC - EQ 0.2% BASE
USFDA APPLICATION NUMBER - 21545
DOSAGE - SPRAY, METERED;NASAL - 0.665MG/SPRAY...DOSAGE - SPRAY, METERED;NASAL - 0.665MG/SPRAY **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 21861
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ABOUT THIS PAGE
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PharmaCompass offers a list of Olopatadine Hydrochloride 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 Olopatadine Hydrochloride manufacturer or Olopatadine Hydrochloride supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Olopatadine Hydrochloride manufacturer or Olopatadine Hydrochloride supplier.
A Opatanol manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Opatanol, including repackagers and relabelers. The FDA regulates Opatanol manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Opatanol 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 Opatanol manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Opatanol supplier is an individual or a company that provides Opatanol active pharmaceutical ingredient (API) or Opatanol finished formulations upon request. The Opatanol suppliers may include Opatanol API manufacturers, exporters, distributors and traders.
click here to find a list of Opatanol suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Opatanol DMF (Drug Master File) is a document detailing the whole manufacturing process of Opatanol active pharmaceutical ingredient (API) in detail. Different forms of Opatanol DMFs exist exist since differing nations have different regulations, such as Opatanol USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Opatanol DMF submitted to regulatory agencies in the US is known as a USDMF. Opatanol USDMF includes data on Opatanol's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Opatanol USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Opatanol 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 Opatanol Drug Master File in Japan (Opatanol JDMF) empowers Opatanol 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 Opatanol JDMF during the approval evaluation for pharmaceutical products. At the time of Opatanol 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 Opatanol 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 Opatanol Drug Master File in Korea (Opatanol KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Opatanol. The MFDS reviews the Opatanol KDMF as part of the drug registration process and uses the information provided in the Opatanol KDMF to evaluate the safety and efficacy of the drug.
After submitting a Opatanol 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 Opatanol API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Opatanol suppliers with KDMF on PharmaCompass.
A Opatanol written confirmation (Opatanol WC) is an official document issued by a regulatory agency to a Opatanol manufacturer, verifying that the manufacturing facility of a Opatanol active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Opatanol APIs or Opatanol finished pharmaceutical products to another nation, regulatory agencies frequently require a Opatanol WC (written confirmation) as part of the regulatory process.
click here to find a list of Opatanol 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 Opatanol as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Opatanol 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 Opatanol 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 Opatanol and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Opatanol NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Opatanol suppliers with NDC on PharmaCompass.
Opatanol 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 Opatanol GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Opatanol GMP manufacturer or Opatanol GMP API supplier for your needs.
A Opatanol CoA (Certificate of Analysis) is a formal document that attests to Opatanol's compliance with Opatanol specifications and serves as a tool for batch-level quality control.
Opatanol CoA mostly includes findings from lab analyses of a specific batch. For each Opatanol 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.
Opatanol may be tested according to a variety of international standards, such as European Pharmacopoeia (Opatanol EP), Opatanol JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Opatanol USP).
