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  • SOLUTION/DROPS;OPHTHALMIC - EQ 0.7% BASE
  • SOLUTION/DROPS;OPHTHALMIC - EQ 0.1% BASE
  • SOLUTION/DROPS;OPHTHALMIC - EQ 0.2% BASE
  • SPRAY, METERED;NASAL - 0.665MG/SPRAY

Looking for 140462-76-6 / Olopatadine Hydrochloride API manufacturers, exporters & distributors?

Olopatadine Hydrochloride manufacturers, exporters & distributors 1

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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, Price,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.

PharmaCompass also assists you with knowing the Olopatadine Hydrochloride API Price utilized in the formulation of products. Olopatadine Hydrochloride API Price is not always fixed or binding as the Olopatadine Hydrochloride Price is obtained through a variety of data sources. The Olopatadine Hydrochloride Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.

API | Excipient name

Olopatadine Hydrochloride

Synonyms

140462-76-6, Olopatadine hcl, Allelock, Pataday, Patanase, Alo4943a

Cas Number

140462-76-6

Unique Ingredient Identifier (UNII)

2XG66W44KF

About Olopatadine Hydrochloride

An antihistamine with mast-cell stabilizing properties used as eye drops in the treatment of ALLERGIC CONJUNCTIVITIS.

Olopatadine Hydrochloride Manufacturers

A Olopatadine Hydrochloride manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Olopatadine Hydrochloride, including repackagers and relabelers. The FDA regulates Olopatadine Hydrochloride manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Olopatadine 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 Olopatadine Hydrochloride manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

Olopatadine Hydrochloride Suppliers

A Olopatadine Hydrochloride supplier is an individual or a company that provides Olopatadine Hydrochloride active pharmaceutical ingredient (API) or Olopatadine Hydrochloride finished formulations upon request. The Olopatadine Hydrochloride suppliers may include Olopatadine Hydrochloride API manufacturers, exporters, distributors and traders.

click here to find a list of Olopatadine Hydrochloride suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

Olopatadine Hydrochloride USDMF

A Olopatadine Hydrochloride DMF (Drug Master File) is a document detailing the whole manufacturing process of Olopatadine Hydrochloride active pharmaceutical ingredient (API) in detail. Different forms of Olopatadine Hydrochloride DMFs exist exist since differing nations have different regulations, such as Olopatadine Hydrochloride USDMF, ASMF (EDMF), JDMF, CDMF, etc.

A Olopatadine Hydrochloride DMF submitted to regulatory agencies in the US is known as a USDMF. Olopatadine Hydrochloride USDMF includes data on Olopatadine Hydrochloride's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Olopatadine Hydrochloride USDMF is kept confidential to protect the manufacturer’s intellectual property.

click here to find a list of Olopatadine Hydrochloride suppliers with USDMF on PharmaCompass.

Olopatadine Hydrochloride JDMF

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 Olopatadine Hydrochloride Drug Master File in Japan (Olopatadine Hydrochloride JDMF) empowers Olopatadine 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 Olopatadine Hydrochloride JDMF during the approval evaluation for pharmaceutical products. At the time of Olopatadine 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 Olopatadine Hydrochloride suppliers with JDMF on PharmaCompass.

Olopatadine Hydrochloride KDMF

In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.

Pharmaceutical companies submit a Olopatadine Hydrochloride Drug Master File in Korea (Olopatadine Hydrochloride KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Olopatadine Hydrochloride. The MFDS reviews the Olopatadine Hydrochloride KDMF as part of the drug registration process and uses the information provided in the Olopatadine Hydrochloride KDMF to evaluate the safety and efficacy of the drug.

After submitting a Olopatadine 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 Olopatadine Hydrochloride API can apply through the Korea Drug Master File (KDMF).

click here to find a list of Olopatadine Hydrochloride suppliers with KDMF on PharmaCompass.

Olopatadine Hydrochloride WC

A Olopatadine Hydrochloride written confirmation (Olopatadine Hydrochloride WC) is an official document issued by a regulatory agency to a Olopatadine Hydrochloride manufacturer, verifying that the manufacturing facility of a Olopatadine Hydrochloride active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Olopatadine Hydrochloride APIs or Olopatadine Hydrochloride finished pharmaceutical products to another nation, regulatory agencies frequently require a Olopatadine Hydrochloride WC (written confirmation) as part of the regulatory process.

click here to find a list of Olopatadine Hydrochloride suppliers with Written Confirmation (WC) on PharmaCompass.

Olopatadine Hydrochloride NDC

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 Olopatadine Hydrochloride as an active pharmaceutical ingredient (API).

Finished drug products

The FDA updates the NDC directory daily. The NDC numbers for Olopatadine Hydrochloride API and other APIs are published in this directory by the FDA.

Unfinished drugs

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 Olopatadine 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.

Compounded drug products

The NDC directory also contains data on finished compounded human drug products that contain Olopatadine Hydrochloride and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Olopatadine Hydrochloride NDC to their finished compounded human drug products, they may choose to do so.

click here to find a list of Olopatadine Hydrochloride suppliers with NDC on PharmaCompass.

Olopatadine Hydrochloride GMP

Olopatadine 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 Olopatadine 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 Olopatadine Hydrochloride GMP manufacturer or Olopatadine Hydrochloride GMP API supplier for your needs.

Olopatadine Hydrochloride CoA

A Olopatadine Hydrochloride CoA (Certificate of Analysis) is a formal document that attests to Olopatadine Hydrochloride's compliance with Olopatadine Hydrochloride specifications and serves as a tool for batch-level quality control.

Olopatadine Hydrochloride CoA mostly includes findings from lab analyses of a specific batch. For each Olopatadine 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.

Olopatadine Hydrochloride may be tested according to a variety of international standards, such as European Pharmacopoeia (Olopatadine Hydrochloride EP), Olopatadine Hydrochloride JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Olopatadine Hydrochloride USP).

Inform the supplier about your product requirements, specifying if you need a product with particular monograph like EP (Ph. Eur.), USP, JP, BP, or any other quality. In addition, clarify whether you need hydrochloride (HCl), anhydricum, base, micronisatum or a specific level of purity. To find reputable suppliers, utilize the filters and select those certified by GMP, FDA, or any other certification as per your requirement.
For your convenience, we have listed synonyms and CAS numbers to help you find the best supplier. The use of synonyms and CAS numbers can be helpful in identifying potential suppliers, but it is crucial to note that they might not always indicate the exact same product. It is important to confirm the product details with the supplier before making a purchase to ensure that it meets your requirements.
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