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JDMF
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VMF
DRUG PRODUCT COMPOSITIONS0
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API SUPPLIERS
Veranova: A CDMO that manages complexity with confidence.
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CA
Veranova: A CDMO that manages complexity with confidence.
NDC
CA
Veranova: A CDMO that manages complexity with confidence.
CA
Veranova: A CDMO that manages complexity with confidence.
CA
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USDMF
Veranova: A CDMO that manages complexity with confidence.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 15089
Submission : 2000-10-13
Status :
Type : II
Veranova: A CDMO that manages complexity with confidence.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 14783
Submission : 2000-03-17
Status :
Type : II
Veranova: A CDMO that manages complexity with confidence.
GDUFA
DMF Review : Complete
Rev. Date : 2013-04-10
Pay. Date : 2013-04-03
DMF Number : 24048
Submission : 2010-07-08
Status :
Type : II
Veranova: A CDMO that manages complexity with confidence.
GDUFA
DMF Review : Complete
Rev. Date : 2013-04-10
Pay. Date : 2013-04-03
DMF Number : 23583
Submission : 2010-03-04
Status :
Type : II
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Malladi is a leader in Ephedrine, Pseudoephedrine Salts & Phenylephrine HCl // USFDA, EDQM, ANSM, KFDA, and TGA inspected.
dl-1-Chloro-1-phenyl-2-aminopropane Hydrochloride
CAS Number : 25394-33-6
End Use API : Amphetamine Sulfate
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 manufa...
PMC Isochem is your partner for smart CDMOs of Intermediates, APIs, & excipients & a catalog of Intermediates & Generic APIs.
CAS Number : 3182-95-4
End Use API : Amphetamine Sulfate
About The Company : PMC Isochem is a CDMO company acquired by PMC International in 2017. It manufactures cGMP intermediates, active pharmaceutical ingredients and functional excipi...
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DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 10M...DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 10MG
USFDA APPLICATION NUMBER - 17078
DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 15M...DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 15MG
USFDA APPLICATION NUMBER - 17078
DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 5MG
USFDA APPLICATION NUMBER - 17078
DOSAGE - SUSPENSION, EXTENDED RELEASE;ORAL - ...DOSAGE - SUSPENSION, EXTENDED RELEASE;ORAL - EQ 1.25MG BASE/ML
USFDA APPLICATION NUMBER - 204325
DOSAGE - TABLET, ORALLY DISINTEGRATING, EXTEN...DOSAGE - TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL - EQ 12.5MG BASE
USFDA APPLICATION NUMBER - 204326
DOSAGE - TABLET, ORALLY DISINTEGRATING, EXTEN...DOSAGE - TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL - EQ 15.7MG BASE
USFDA APPLICATION NUMBER - 204326
DOSAGE - TABLET, ORALLY DISINTEGRATING, EXTEN...DOSAGE - TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL - EQ 18.8MG BASE
USFDA APPLICATION NUMBER - 204326
DOSAGE - TABLET, ORALLY DISINTEGRATING, EXTEN...DOSAGE - TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL - EQ 3.1MG BASE
USFDA APPLICATION NUMBER - 204326
DOSAGE - TABLET, ORALLY DISINTEGRATING, EXTEN...DOSAGE - TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL - EQ 6.3MG BASE
USFDA APPLICATION NUMBER - 204326
DOSAGE - TABLET, ORALLY DISINTEGRATING, EXTEN...DOSAGE - TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL - EQ 9.4MG BASE
USFDA APPLICATION NUMBER - 204326
DOSAGE - SUSPENSION, EXTENDED RELEASE;ORAL - ...DOSAGE - SUSPENSION, EXTENDED RELEASE;ORAL - 2MG/ML;EQ 0.5MG BASE/ML
USFDA APPLICATION NUMBER - 208147
DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 12MG...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 12MG;EQ 3MG BASE
USFDA APPLICATION NUMBER - 210526
DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 16MG...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 16MG;EQ 4MG BASE
USFDA APPLICATION NUMBER - 210526
DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 4MG;...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 4MG;EQ 1MG BASE
USFDA APPLICATION NUMBER - 210526
DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 8MG;...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 8MG;EQ 2MG BASE
USFDA APPLICATION NUMBER - 210526
DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 1.2...DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 1.25MG;1.25MG;1.25MG;1.25MG
USFDA APPLICATION NUMBER - 21303
DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 2.5...DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 2.5MG;2.5MG;2.5MG;2.5MG
USFDA APPLICATION NUMBER - 21303
DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 3.7...DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 3.75MG;3.75MG;3.75MG;3.75MG
USFDA APPLICATION NUMBER - 21303
DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 5MG...DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 5MG;5MG;5MG;5MG
USFDA APPLICATION NUMBER - 21303
DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 6.2...DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 6.25MG;6.25MG;6.25MG;6.25MG
USFDA APPLICATION NUMBER - 21303
DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 7.5...DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 7.5MG;7.5MG;7.5MG;7.5MG
USFDA APPLICATION NUMBER - 21303
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PharmaCompass offers a list of Amphetamine Sulfate 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 Amphetamine Sulfate manufacturer or Amphetamine Sulfate supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Amphetamine Sulfate manufacturer or Amphetamine Sulfate supplier.
PharmaCompass also assists you with knowing the Amphetamine Sulfate API Price utilized in the formulation of products. Amphetamine Sulfate API Price is not always fixed or binding as the Amphetamine Sulfate Price is obtained through a variety of data sources. The Amphetamine Sulfate Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A ADDERALL XR 30-1 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of ADDERALL XR 30-1, including repackagers and relabelers. The FDA regulates ADDERALL XR 30-1 manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. ADDERALL XR 30-1 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 ADDERALL XR 30-1 manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A ADDERALL XR 30-1 supplier is an individual or a company that provides ADDERALL XR 30-1 active pharmaceutical ingredient (API) or ADDERALL XR 30-1 finished formulations upon request. The ADDERALL XR 30-1 suppliers may include ADDERALL XR 30-1 API manufacturers, exporters, distributors and traders.
click here to find a list of ADDERALL XR 30-1 suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A ADDERALL XR 30-1 DMF (Drug Master File) is a document detailing the whole manufacturing process of ADDERALL XR 30-1 active pharmaceutical ingredient (API) in detail. Different forms of ADDERALL XR 30-1 DMFs exist exist since differing nations have different regulations, such as ADDERALL XR 30-1 USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A ADDERALL XR 30-1 DMF submitted to regulatory agencies in the US is known as a USDMF. ADDERALL XR 30-1 USDMF includes data on ADDERALL XR 30-1's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The ADDERALL XR 30-1 USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of ADDERALL XR 30-1 suppliers with USDMF on PharmaCompass.
A ADDERALL XR 30-1 CEP of the European Pharmacopoeia monograph is often referred to as a ADDERALL XR 30-1 Certificate of Suitability (COS). The purpose of a ADDERALL XR 30-1 CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of ADDERALL XR 30-1 EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of ADDERALL XR 30-1 to their clients by showing that a ADDERALL XR 30-1 CEP has been issued for it. The manufacturer submits a ADDERALL XR 30-1 CEP (COS) as part of the market authorization procedure, and it takes on the role of a ADDERALL XR 30-1 CEP holder for the record. Additionally, the data presented in the ADDERALL XR 30-1 CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the ADDERALL XR 30-1 DMF.
A ADDERALL XR 30-1 CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. ADDERALL XR 30-1 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 ADDERALL XR 30-1 suppliers with CEP (COS) 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 ADDERALL XR 30-1 as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for ADDERALL XR 30-1 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 ADDERALL XR 30-1 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 ADDERALL XR 30-1 and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a ADDERALL XR 30-1 NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of ADDERALL XR 30-1 suppliers with NDC on PharmaCompass.
ADDERALL XR 30-1 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 ADDERALL XR 30-1 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 ADDERALL XR 30-1 GMP manufacturer or ADDERALL XR 30-1 GMP API supplier for your needs.
A ADDERALL XR 30-1 CoA (Certificate of Analysis) is a formal document that attests to ADDERALL XR 30-1's compliance with ADDERALL XR 30-1 specifications and serves as a tool for batch-level quality control.
ADDERALL XR 30-1 CoA mostly includes findings from lab analyses of a specific batch. For each ADDERALL XR 30-1 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.
ADDERALL XR 30-1 may be tested according to a variety of international standards, such as European Pharmacopoeia (ADDERALL XR 30-1 EP), ADDERALL XR 30-1 JP (Japanese Pharmacopeia) and the US Pharmacopoeia (ADDERALL XR 30-1 USP).
