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Pharmaffiliates Analytics and Synthetics Pvt Ltd
About Pharmaffiliates Analytics and Synthetics Pvt Ltd
Pharmaffiliates Analytics & Synthetics (P) Ltd, is an integrated CRO (Contract Research Organization) established in year 2001. Presently we are US-FDA Audited & Accepted Facility and bagged with ISO 17034, ISO 17025 & ISO 9001 Certification. We are specialized in research via synthesis of complex and difficult to make compounds (Impurities & Metabolites), innovative organic molecules to support and accelerate the drug discovery research of pharma and biotech companies. We adapt unique synthetic approaches and execute in robust ways for making complex and unknown impurities with their characterization data. Thus we make the drug discovery process more efficient, cost-effective while maintaining the highest standards of quality. With the collective efforts of our team of 130 scientists so, far, we have performed more than 300 method validations & many of these validation reports submitted to EU & US & sought approvals. Work is carried in line with the ICH and the cGMP guidance.
Our experience, combined with state-of- the-art laboratories and manufacturing facilities lets us become an ideal partner for the pharmaceutical and drug discovery industry , we undertake projects for Process Research, Scale up , Custom Synthesis, CRAMS, Impurity synthesis, Isotope labeled compounds (Deuterium Compounds), Chiral Compounds, Phytochemicals, Glucuronides, Reference Standards, Polymorphism studies, Analytical Method Development & Validation, Stability studies & Evaluation are of our core group activities.
So far we have successfully established a library of more than 30000 compounds with their complete characterization data.
Our Products & Services :
1. CUSTOM SYNTHESIS
A. Impurities & Metabolites
B. Stable Isotopes - Deuterium & Labelled Compounds
C. Typical compounds - Dimers, trimers, etc.
D. Pesticides, Phytochemicals, Petrochemicals
2. ANALYTICAL SERVICES
A. Identification of Unknown Impurities
B. Impurity Profiling
C. Method Development & Method Validation
D. Stability Studies
E. Transfering Technologies of APIs
F. Forced Degradation Studies
3. REGULATORY SERVICES
A. DMF Filing
B. Dossier Preparation
C. Process Development
D. New Molecule Development
E. Third Party Audits
FTE, Fixed Bid, Milestone based options
Each and every Standard supplied with detailed COA including the complete structure elucidation and interpretation supported data i.e IR, NMR, MASS & HPLC Chromatogram. Also any additional data like 13C-NMR, C-HNS, Q-NMR & TGA can be provided on special request. Majority of our Impurities are above 95% purity. Impurities and standards which are not available in our catalogue can be Custom Synthesized as per your requirement.
Products from Pharmaffiliates Analytics and Synthetics Pvt Ltd
Laboratory information management system (LIMS)Electronic Laboratory Notebooks (ELN) Enterprises Resource Planning (ERP) Customised Application Development (Online/Offline) For Sales, Purchase, Stores, R&D, Production,QA/QC, Dispatch
Pharmaffiliates Analytics & Synthetics (P) Ltd, is an integrated CRO (Contract Reserach Organisition) established in year 2005. Presently our group is consist of more than 65 Scientists with 3 R&D Centres offering its expertise in Custom Synthesis, Impurity synthesis, Isotoped lebelled compounds (Deuterium Compounds) , Reference Standards.Pharmaffiliates is having more than 3000 In-house Impurities readily available.
For more details please send your enquiry on [email protected]
Pharmaffiliates is providing all the Analytical Services (i.e. Method Development, Method Validation & Transfer, Stability Studies, Contract Analysis, etc)
Pharmaffiliates providing the full support for the Regulatory Services (i.e. DMF Filling, Dossier Preparations, etc)
Pharmaffiliates offers Stability Studies.
Formulation Product development team includes experienced Scientists who continuously work for the development of New Drug Product, Dietary Supplement, Generic Drug Products, Novel Drugs Delivery System (NDDS), New fixed dose combination products and Herbal Cosmetics & Herbal Products.
We offer New product development services for ANDA, Export and Domestic market (DCGI) in different dosage forms.Solid Dosage Forms: Tablets (Chewable, Mouth dissolving, Sustained release, Bilayered, Gastro retentive, Extended release, Controlled release)
Capsules : Hard Gelatin Capsules | Soft Gelatin Capsule
Dry Powder : Syrups/Suspensions (In Sachets/Bottles)
Liquid Orals : Solution | Suspension (Sustained Release Suspension)
Ointments & Creams : Transparent gels | Lotions | Ointments |Creams | Emulsion
Ready to use coating material for film as well as enteric coating
Herbal & Nutraceutical Products
Herbal Products Premixes of different APIs
"A reliable and preferred CRAMS (Contract Research And Manufacturing Services) partner in providing innovative Pharmaceutical solutions"
SERVICES OFFERED:* Early phase drug development* Process research and development* CCS (Custom chemical synthesis)* FTE (Full Time Equivalent) based projects* Regulatory submission support (CMC)
* R&D with strong chemistry capability and track record* Cost competitive, regulatory – EHS compliant and timely deliveries* State of the art R&D center equipped with modern analytical instruments and Kilo lab.* Dedicated QA, RA and SCM support* Confidentiality and IP protection* Capable of handling wide range of reactions and reagents* Wide range of reactors, supporting equipments and utilities with solvent recovery and ETP plant
Product CAS No : 976-71-6, Canrenone, Aldosterone - In house impurity, (17α)-17-Hydroxy-3-oxo-pregna-4,6-diene-21-carboxylic Acid γ-LactonePharmaffiliates offering Canrenone, Aldosterone - In house impurity which is also known as aldadiene and it is a steroidal antimineralocorticoid. Synonyms:- (17α)-17-Hydroxy-3-oxo-pregna-4,6-diene-21-carboxylic Acid γ-Lactone. You can also search this product with 17a-2-Carboxyethyl-17ß-hydroxyandrosta-4,6-dien-3-one Lactone; Phanurane. Contact us at: [email protected] https://pharmaffiliates.com/canrenone/aldosterone-in-house-impurity-impurity/197
Product CAS No : 52490-15-0, Amiodarone Hydrochloride - Impurity E, (2-Butyl-benzofuran-3-yl)-(4-hydroxy-phenyl)-methanone; (2-Butylbenzofuran-3-yl)-(4-hydroxyphenyl)ketone; USP Amiodarone Related Compound EPharmaffiliates offering Amiodarone Hydrochloride - Impurity E which also known as 2-BUTYL-3-(4-HYDROXYBENZOYL)BENZOFURAN, It is an impurity of Amiodarone. Amiodarone is an antiarrhythmic medication used to treat and prevent a number of types of irregular heartbeats.
Synonyms:- (2-Butyl-benzofuran-3-yl)-(4-hydroxy-phenyl)-methanone; (2-Butylbenzofuran-3-yl)-(4-hydroxyphenyl)ketone; USP Amiodarone Related Compound E; Contact us at: [email protected]
Pharmaffiliates offers a wide range of products which includes (2e)-2-butenedioic acid 1-ethyl ester calcium salt. It belongs to furosemide category. Contact us for more information.
Product CAS No : 1217462-63-9, Acyclovir - Impurity, (2S)-2-Azido-3-methylbutanoic Acid Cyclohexylammonium SaltPharmaffiliates offering Acyclovir - Impurity which also known as (2S)-2-Azido-3-methylbutanoic Acid Cyclohexylammonium Salt. It is an impurity of Acyclovir.Acyclovir is an antiviral drug, used in the treatment of Herpes and AIDS. Synonyms:- (2S)-2-Azido-3-methylbutanoic Acid Cyclohexylammonium Salt. Contact us at: [email protected] Visit Products;- https://pharmaffiliates.com/s-2-azido-isovaleric-acid-cyclohexylammonium-salt/acyclovir-in-house-impurity-impurity/111
Pharmaffiliates Analytics and Synthetics Pvt Ltd Resources
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