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Bulk Manufacturing & Custom Synthesis (BMCS) |
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We have taken up the challenge to manufacture reagents and powders in bulk scale to meet the critical requirements of several industries that we serve. SRL currently offers more than 2500 products and supports its customers in all phases of the drug manufacturing process, from research, quality control and commercial production, through to providing service in concrete safety and regulatory issues. We are pleased to investigate and provide a quote for your requirements for any quantity; from milligrams to tons. For Custom Synthesis a realistic minimum order volume depends on many factors, but in principal SRL can help you start with small quantities for laboratory testing, scale up for development, and finally go on to economical continuous manufacturing on the ton scale.
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Confidentiality
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This is the first step in the BMCS Business, where we value all communications we have with you and make sure that there is clear, transparent & ethical practice of 100% confidentiality with the information you will share with SRL. Irrespective of whether we have a formal secrecy agreement in place with you, SRL will handle your enquiry and other information with the utmost confidentiality. Should you wish to have a formal agreement put in place before disclosing any details, we will be pleased to arrange this.
Customer's Synthetic Route
We examine your requirements based on your own disclosed technical information. If we feel that additional chemistry or analytical testing is required we will discuss this with you and allow for any extra work in the quotation.
SRL In-house Synthetic Route
Where you have no synthetic information about the product required, SRL will use its skills to explore options. Having carefully reviewed these, we will then provide a quotation based on our in-house expertise.
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| Manufacturing Capability |
SRL‘s Bulk Manufacturing and Custom Synthesis (BMCS) business has broadened its production at our Taloja MIDC site to include existing and new bulk fine chemicals which are being manufactured at commercial scales. Production of the raw materials have been on since 2011 at this site and complements the existing offering of highly regulated active and non-active pharmaceutical ingredients manufactured here. Most of the products manufactured at the Taloja MIDC bulk plant facility meet and exceed IP, BP, USP & Ph. Eur regulation; follow Current Good Manufacturing Practices (cGMPs) for biopharmaceutical production; and comply with International Consortium for Innovation and Quality in Pharmaceutical Development.
Quality Certifications
ISO 9001-2015
FDA (Maharashtra FDA)
cGMP
CE
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QC Instruments
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| HPLC (High Pressure Liquid Chromatography) |
GC (Gas Chromatography) |
| UV Spectrophotometer |
Karl Fisher Apparatus |
| Refractometer |
Electrophoresis Apparatus |
| TLC Equipment |
Single Pan & Analytical Balance |
| pH Meters |
Polarimeter |
| Particle Size Analysis Microscope |
Conductometer |
| Flame Photometer | |
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Reaction Capabilities |
| Acid Chloride Preparations |
Jones Oxidation |
| Aldol & Crossed Aldol Reaction |
Lithiation Chemistry |
| Assymetric Reduction |
Mignonac Reaction |
| Bromination |
Mitosonobu Esterification |
| Caroxylation |
Nitration |
| Cryogenic Reaction |
Nitrosation |
| Cyclization |
Oximination |
| Cyclo Addition (4 + 2, 4 + 3) Reaction |
Pachmann Condensation |
| Dehydration |
Perkin Reaction |
| Esterification |
Sandmeyer Reaction |
| Formylation |
Sonogashira Coupling |
| Friedel-Craft |
Sulfonation |
| Grignard Reaction |
Suzuki Coupling |
| Heck Reaction |
Swern Oxidation |
| Hydrochloride preparation |
Williamson‘s Ether Synthesis |
| Iodination |
Writing-Homer Reaction |
| Ion exchange Reactions | |
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Equipment
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| SS & Glass-lined Reactors with distillation columns |
All Glass Reactors |
| SS Centrifuges |
SS Nutsche Filters |
| SS Sparkler Filters |
SS Pulverizers, Sifters and Blenders |
| Vacuum Tray Dryers |
SS Rotocone Vacuum Dryers |
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Supporting Utilities at Manufacturing Plant
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| Chilled Brine Plant |
Cooling Water and Chilled Water Plant |
| Boiler and Oil Heating System |
High Pressure Vacuum System |
| Micron-filter Air Purification System |
DM Water Plant, Nitrogen Plant, Scrubbers |
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Target Audience
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| We can provide raw materials for various type of Industries some are mentioned below |
| Active Pharmaceutical Ingredients (API) (Human & Veterinary) |
Antibodies |
| Automobile & Aeronautics |
Beverages |
| Biocides, Insecticides & Crop Sciences |
Bio-Fermentation (Upstream & Downstream) |
| Biosimilars |
Blood Plasma |
| Confectionary and Foods |
Consumer Durables |
| Cosmetics |
Dairy |
| Diagnostic Kits |
Electronics |
| Engineering |
Excipients & Intermediates (Organic & Inorganic) |
| Fast Moving Consumer Goods (FMCG) |
Formulations (New & Generic) |
| Heavy Machinery |
Home Care & Sanitation |
| Hormones |
Injectables |
| Neutraceuticals |
Peptides |
| Personal Care Products |
Protein Purification |
| Specialty Chemicals |
Vaccines (Human & Veterinary) |
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Tech-Packs
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SRL not only provides the raw materials through its BMCS program, but we also cater to the strict documentation requirements which our customers ask. Since the last decade, India has become a hub for the regulated as well as the non-regulated pharmaceutical markets, and to serve them we offer complete VQ documents with all the technical, commercial and ethical information that we can provide.
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Document support
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| Aflatoxin free statement |
Allergen free certificate |
| Brief description of manufacturing locations, capabilities |
Certificate of analysis (COA) / Method of analysis (MOA) |
| Company Organogram |
Dioxan free certificate |
| GC, HPLC, NMR graphs |
Gluten free certificate |
| Kosher & Halal certificate |
Latex free statement |
| List of equipment and instrumentation |
Material safety data sheet (MSDS) |
| Melamine free certificate |
Metal catalyst statement |
| Microbial contamination certificate |
Quality management certificate (QMS) |
| Residual solvent & impurity profiling |
Route of synthesis (ROS) / Process flow chart |
| Stability data |
TSE/BSE Declaration |
| Vendor Questionnaire (VQ) |
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Post Sales Support
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We at SRL take special care to value our customers with utmost seriousness post-sales. Customers requiring additional services of more document support, pre-shipment sampling for repeat orders, production planning for scale-up and addressing non-conformity issues are some of the areas which we address. In times of product rejections due to storage or any other issues, we provide a complete CAPA (Corrective And Preventive Action) analysis document and such documents are recorded for future product improvements.
Today we provide a helping hand to the world‘s top 100 pharmaceutical companies to file successful ANDA (Abbreviated New Drug Application) filings in both regulated and non-regulated markets. We are ready to partner with you, so do get in touch with us on marketing@srlchem.com
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BMCS Working
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Customer Sends New Inquiry to SRL
Confidentiality Agreement
Finalizing the Production Process/ Synthetic Route
Submission of Quotation with Terms
Sampling, Audit & Final Product Approval
Manufacturing and VQ Documentation
Product Dispatch with COA & Documents
After-sales Support if/when required
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