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DRUG PRODUCT COMPOSITIONS0
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API SUPPLIERS
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USDMF
Veranova: A CDMO that manages complexity with confidence.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 10137
Submission : 1993-03-05
Status :
Type : II
Veranova: A CDMO that manages complexity with confidence.
GDUFA
DMF Review : Complete
Rev. Date : 2013-01-31
Pay. Date : 2013-01-07
DMF Number : 19547
Submission : 2006-06-26
Status :
Type : II
Noramco is a partner to the pharmaceutical industry for controlled substance development & manufacturing.
GDUFA
DMF Review : Complete
Rev. Date : 2014-07-07
Pay. Date : 2013-07-19
DMF Number : 27208
Submission : 2013-07-12
Status :
Type : II
Noramco is a partner to the pharmaceutical industry for controlled substance development & manufacturing.
GDUFA
DMF Review : Complete
Rev. Date : 2013-03-27
Pay. Date : 2012-11-23
DMF Number : 22244
Submission : 2008-12-19
Status :
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2016-09-19
Pay. Date : 2015-09-15
DMF Number : 29411
Submission : 2016-05-27
Status :
Type : II
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]CEP/COS
Veranova: A CDMO that manages complexity with confidence.
Certificate Number : R1-CEP 2009-078 - Rev 00
Status : Valid
Issue Date : 2015-01-27
Type : Chemical
Substance Number : 2235
Veranova: A CDMO that manages complexity with confidence.
Certificate Number : CEP 2017-119 - Rev 01
Status : Valid
Issue Date : 2024-10-14
Type : Chemical
Substance Number : 2235
SCI Pharmtech offers high-quality, cost-effective APIs, advanced intermediates, & custom products with global expertise and precision.
Certificate Number : R1-CEP 2012-168 - Rev 01
Status : Valid
Issue Date : 2022-09-09
Type : Chemical
Substance Number : 2235
Cohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.
Certificate Number : CEP 2017-181 - Rev 02
Status : Valid
Issue Date : 2024-12-05
Type : Chemical
Substance Number : 2235
Noramco is a partner to the pharmaceutical industry for controlled substance development & manufacturing.
Certificate Number : CEP 2018-030 - Rev 04
Status : Valid
Issue Date : 2024-09-26
Type : Chemical
Substance Number : 2235
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results] JDMF
Veranova: A CDMO that manages complexity with confidence.
Registration Number : 302MF10009
Registrant's Address : 10 Wheatfield Road, Edinburgh EH11 2QA, United Kingdom
Initial Date of Registration : 2020-01-17
Latest Date of Registration : 2020-01-17
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]EU WC
Cohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.
Methylphenidate Hydrochloride EP/USP
Date of Issue : 2022-08-25
Valid Till : 2025-07-02
Written Confirmation Number : WC-0195
Address of the Firm : Plot No. 3102/B, GIDC, Industrial Estate, Ankleshwar-393 002, Bharuch, Gujarat I...
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FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Listed Suppliers
Veranova: A CDMO that manages complexity with confidence.
About the Company : Veranova is a global leader in the development and manufacturing of specialist and complex APIs for pharma and biotech customers. We have over 50 years of experience navigating the...
SCI Pharmtech offers high-quality, cost-effective APIs, advanced intermediates, & custom products with global expertise and precision.
About the Company : SCI Pharmtech Inc. offers APIs, advanced intermediates, and custom products, focusing on quick development and cost-effective production. Our research labs, pilot plants, and produ...
Cohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.
About the Company : Cohance Lifesciences is a leading CDMO and API platform, offering products and services across all phases of a molecule’s lifecycle from development to commercialzation. With our...
Malladi is a leader in Ephedrine, Pseudoephedrine Salts & Phenylephrine HCl // USFDA, EDQM, ANSM, KFDA, and TGA inspected.
About the Company : Malladi Drugs & Pharmaceuticals Ltd was founded in 1980 by microbiologist Mr. M L N Sastry. Within a few years, Malladi established itself as a leader in manufacturing ephedrine an...
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...
Noramco is a partner to the pharmaceutical industry for controlled substance development & manufacturing.
About the Company : Founded in 1979, Noramco specializes in the development and manufacturing of APIs for both opioid and non-opioid products. With expertise in controlled substance development and ma...
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]API Reference Price
API/FDF Prices: Book a Demo to explore the features and consider upgrading later
API Imports and Exports
Drugs in Development
Lead Product(s) : Methylphenidate Hydrochloride
Therapeutic Area : Psychiatry/Psychology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Dr. Reddy’s Methylphenidate Hydrochloride Extended-Release Tablets, USP are available in strengths of 18 mg, 27 mg, 36 mg, and 54 mg tablets in bottle count sizes of 100.
Product Name : Methylphenidate Hydrochloride-Generic
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
March 09, 2020
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]FDF Dossiers
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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 - TABLET;ORAL - 10MG
USFDA APPLICATION NUMBER - 10187
DOSAGE - TABLET;ORAL - 20MG
USFDA APPLICATION NUMBER - 10187
DOSAGE - TABLET;ORAL - 5MG
USFDA APPLICATION NUMBER - 10187
DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 20MG...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 18029
DOSAGE - FOR SUSPENSION, EXTENDED RELEASE;ORA...DOSAGE - FOR SUSPENSION, EXTENDED RELEASE;ORAL - 5MG/ML
USFDA APPLICATION NUMBER - 202100
DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 10M...DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 10MG
USFDA APPLICATION NUMBER - 205831
DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 15M...DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 15MG
USFDA APPLICATION NUMBER - 205831
DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 20M...DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 20MG
USFDA APPLICATION NUMBER - 205831
DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 30M...DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 30MG
USFDA APPLICATION NUMBER - 205831
DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 40M...DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 40MG
USFDA APPLICATION NUMBER - 205831
DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 50M...DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 50MG
USFDA APPLICATION NUMBER - 205831
DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 60M...DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 60MG
USFDA APPLICATION NUMBER - 205831
DOSAGE - TABLET, EXTENDED RELEASE, CHEWABLE;O...DOSAGE - TABLET, EXTENDED RELEASE, CHEWABLE;ORAL - 20MG
USFDA APPLICATION NUMBER - 207960
DOSAGE - TABLET, EXTENDED RELEASE, CHEWABLE;O...DOSAGE - TABLET, EXTENDED RELEASE, CHEWABLE;ORAL - 30MG
USFDA APPLICATION NUMBER - 207960
DOSAGE - TABLET, EXTENDED RELEASE, CHEWABLE;O...DOSAGE - TABLET, EXTENDED RELEASE, CHEWABLE;ORAL - 40MG
USFDA APPLICATION NUMBER - 207960
DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 18MG
USFDA APPLICATION NUMBER - 21121
DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 27MG
USFDA APPLICATION NUMBER - 21121
DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 36MG
USFDA APPLICATION NUMBER - 21121
DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 54MG
USFDA APPLICATION NUMBER - 21121
DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 10M...DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 10MG
USFDA APPLICATION NUMBER - 21259
DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 20M...DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 20MG
USFDA APPLICATION NUMBER - 21259
DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 30M...DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 30MG
USFDA APPLICATION NUMBER - 21259
DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 40M...DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 40MG
USFDA APPLICATION NUMBER - 21259
DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 50M...DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 50MG
USFDA APPLICATION NUMBER - 21259
DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 60M...DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 60MG
USFDA APPLICATION NUMBER - 21259
DOSAGE - SOLUTION;ORAL - 10MG/5ML
USFDA APPLICATION NUMBER - 21419
DOSAGE - SOLUTION;ORAL - 5MG/5ML
USFDA APPLICATION NUMBER - 21419
DOSAGE - TABLET, CHEWABLE;ORAL - 10MG **Feder...DOSAGE - TABLET, CHEWABLE;ORAL - 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 21475
DOSAGE - TABLET, CHEWABLE;ORAL - 2.5MG **Fede...DOSAGE - TABLET, CHEWABLE;ORAL - 2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 21475
DOSAGE - TABLET, CHEWABLE;ORAL - 5MG **Federa...DOSAGE - TABLET, CHEWABLE;ORAL - 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 21475
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ABOUT THIS PAGE
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PharmaCompass offers a list of Methylphenidate 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 Methylphenidate Hydrochloride manufacturer or Methylphenidate Hydrochloride supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Methylphenidate Hydrochloride manufacturer or Methylphenidate Hydrochloride supplier.
PharmaCompass also assists you with knowing the Methylphenidate Hydrochloride API Price utilized in the formulation of products. Methylphenidate Hydrochloride API Price is not always fixed or binding as the Methylphenidate Hydrochloride Price is obtained through a variety of data sources. The Methylphenidate Hydrochloride Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Concerta manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Concerta, including repackagers and relabelers. The FDA regulates Concerta manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Concerta 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 Concerta manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Concerta supplier is an individual or a company that provides Concerta active pharmaceutical ingredient (API) or Concerta finished formulations upon request. The Concerta suppliers may include Concerta API manufacturers, exporters, distributors and traders.
click here to find a list of Concerta suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Concerta DMF (Drug Master File) is a document detailing the whole manufacturing process of Concerta active pharmaceutical ingredient (API) in detail. Different forms of Concerta DMFs exist exist since differing nations have different regulations, such as Concerta USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Concerta DMF submitted to regulatory agencies in the US is known as a USDMF. Concerta USDMF includes data on Concerta's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Concerta USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Concerta 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 Concerta Drug Master File in Japan (Concerta JDMF) empowers Concerta 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 Concerta JDMF during the approval evaluation for pharmaceutical products. At the time of Concerta 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 Concerta 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 Concerta Drug Master File in Korea (Concerta KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Concerta. The MFDS reviews the Concerta KDMF as part of the drug registration process and uses the information provided in the Concerta KDMF to evaluate the safety and efficacy of the drug.
After submitting a Concerta 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 Concerta API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Concerta suppliers with KDMF on PharmaCompass.
A Concerta CEP of the European Pharmacopoeia monograph is often referred to as a Concerta Certificate of Suitability (COS). The purpose of a Concerta CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Concerta EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Concerta to their clients by showing that a Concerta CEP has been issued for it. The manufacturer submits a Concerta CEP (COS) as part of the market authorization procedure, and it takes on the role of a Concerta CEP holder for the record. Additionally, the data presented in the Concerta CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Concerta DMF.
A Concerta CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Concerta 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 Concerta suppliers with CEP (COS) on PharmaCompass.
A Concerta written confirmation (Concerta WC) is an official document issued by a regulatory agency to a Concerta manufacturer, verifying that the manufacturing facility of a Concerta active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Concerta APIs or Concerta finished pharmaceutical products to another nation, regulatory agencies frequently require a Concerta WC (written confirmation) as part of the regulatory process.
click here to find a list of Concerta 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 Concerta as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Concerta 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 Concerta 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 Concerta and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Concerta NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Concerta suppliers with NDC on PharmaCompass.
Concerta 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 Concerta 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 Concerta GMP manufacturer or Concerta GMP API supplier for your needs.
A Concerta CoA (Certificate of Analysis) is a formal document that attests to Concerta's compliance with Concerta specifications and serves as a tool for batch-level quality control.
Concerta CoA mostly includes findings from lab analyses of a specific batch. For each Concerta 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.
Concerta may be tested according to a variety of international standards, such as European Pharmacopoeia (Concerta EP), Concerta JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Concerta USP).
