Close
4

Athena Athena

X

Find Nifedipine manufacturers, exporters & distributors on PharmaCompass

PharmaCompass
Related ProductsRelated Products
API SUPPLIERS
API Suppliers

API Suppliers

US DMFs Filed

US DMFs Filed

CEP/COS Certifications

CEP/COS Certifications

JDMFs Filed

JDMFs Filed

Other Certificates

Other Certificates

Other Suppliers

Other Suppliers

API REF. PRICE (USD / KG)
81
INTERMEDIATES
DOSSIERS // FDF
USA (Orange Book)

USA (Orange Book)

Europe

Europe

Canada

Canada

Australia

Australia

South Africa

South Africa

Uploaded Dossiers

Uploaded Dossiers

GLOBAL SALES (USD Million)

U.S. Medicaid

Annual Reports

EXCIPIENTS
PATENTS & EXCLUSIVITIES

USFDA Orange Book Patents

0

USFDA Exclusivities

0

DIGITAL CONTENT

Blog #PharmaFlow

News

REF STANDARD

EDQM

USP

JP

0

Other Listed Suppliers

SERVICES
left grey arrow
right gray arrow
  • CAPSULE;ORAL - 10MG
  • CAPSULE;ORAL - 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
  • TABLET, EXTENDED RELEASE;ORAL - 30MG
  • TABLET, EXTENDED RELEASE;ORAL - 60MG
  • TABLET, EXTENDED RELEASE;ORAL - 90MG
  • TABLET, EXTENDED RELEASE;ORAL - 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
  • TABLET, EXTENDED RELEASE;ORAL - 60MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
  • TABLET, EXTENDED RELEASE;ORAL - 90MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Looking for 21829-25-4 / Nifedipine API manufacturers, exporters & distributors?

Nifedipine manufacturers, exporters & distributors 1

27

PharmaCompass offers a list of Nifedipine 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 Nifedipine manufacturer or Nifedipine supplier for your needs.

Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Nifedipine manufacturer or Nifedipine supplier.

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

API | Excipient name

Nifedipine

Synonyms

21829-25-4, Adalat, Procardia, Procardia xl, Adalat cc, Cordipin

Cas Number

21829-25-4

Unique Ingredient Identifier (UNII)

I9ZF7L6G2L

About Nifedipine

A potent vasodilator agent with calcium antagonistic action. It is a useful anti-anginal agent that also lowers blood pressure.

Nifedipine Manufacturers

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

Nifedipine Suppliers

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

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

Nifedipine USDMF

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

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

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

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

Nifedipine KDMF

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

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

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

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

Nifedipine CEP

A Nifedipine CEP of the European Pharmacopoeia monograph is often referred to as a Nifedipine Certificate of Suitability (COS). The purpose of a Nifedipine CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Nifedipine EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Nifedipine to their clients by showing that a Nifedipine CEP has been issued for it. The manufacturer submits a Nifedipine CEP (COS) as part of the market authorization procedure, and it takes on the role of a Nifedipine CEP holder for the record. Additionally, the data presented in the Nifedipine CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Nifedipine DMF.

A Nifedipine CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Nifedipine 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 Nifedipine suppliers with CEP (COS) on PharmaCompass.

Nifedipine WC

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

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

Nifedipine 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 Nifedipine as an active pharmaceutical ingredient (API).

Finished drug products

The FDA updates the NDC directory daily. The NDC numbers for Nifedipine 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 Nifedipine 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 Nifedipine and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Nifedipine NDC to their finished compounded human drug products, they may choose to do so.

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

Nifedipine GMP

Nifedipine 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 Nifedipine 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 Nifedipine GMP manufacturer or Nifedipine GMP API supplier for your needs.

Nifedipine CoA

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

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

Nifedipine may be tested according to a variety of international standards, such as European Pharmacopoeia (Nifedipine EP), Nifedipine JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Nifedipine 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.
Ask Us for Pharmaceutical Supplier and Partner
Ask Us, Find A Supplier / Partner
No Commissions, No Strings Attached, Get Connected for FREE

What are you looking for?

How can we help you?

The request can't be empty

Please read our Privacy Policy carefully

You must agree to the privacy policy

The name can't be empty
The company can't be empty.
The email can't be empty Please enter a valid email.
The mobile can't be empty
Post Enquiry
POST ENQUIRY