Overview
We are expert in Pharmaceutical Manufacturing since 20 years.
Product Development Formulation Development
Our in-house Research and Development centre is located at Changodar GIDC, Ahmedabad which enable core research activities of generic product development for various regulated markets across different continents. We are a Global Pharmaceutical Manufacturing and Exporting organization who has never failed a customer. Our Contract Manufacturing along with Generic Product Development in India makes us one of the best Pharmaceutical Manufacturing Company in India. We have an extensive product portfolio over all the major therapeutic areas.
The overall objective of this facility is to develop pharmaceutical products on a Contract basis and to design and develop the products indigenously for the ever-expanding Pharmaceutical market and exceed our customer expectations.
Our experienced R&D team develops complex finished formulations that comply with the highest regulatory requirements. With several years of collective experience, we are able to develop complex and niche molecules for our clients:
Technology
Developed products are available for Technology transfer to manufacture validation batches at approved manufacturing facilities. Meaningful product development is the one that is capable of being transferred from the R&D scale to production scale and thereafter upscale of the batches.
We take full responsibility to ensure the product manufacturing and analytical technology is transferred from the R&D to production. The exhibit/submission and commercial batches, both, are manufactured at ease.
- BA/BE Studies
Bio-Equivalence studies are conducted with strict monitoring at CRO’s accredited by Regulatory authorities for GCP / GLP compliance.
- Dossier(s)
Regulatory compliance is an integral part of the product registration process. We extend our services to compilation of the dossier and responses to queries to health authorities. Dossiers in ETCD ready-to-publish formats are provided.
Production Capacity:
| Productions Unit | Yearly Production |
|---|---|
| Tablets | 240 Million |
| Hard Gelatin Capsules | 20 Million |
| Soft Gelatin Capsules | 10 Million |
| Liquid Syrup | 6.0 Million |
| Dry Syrups | 6.0 Million |
| External Preparations/ Ointments/ Creams | 6.0 Million |
| Eye/ Ear Drops | 12 Million |
| Powders | 3.0 Million |
| Yearly Production | Yearly Production |
|---|---|
| Liquid Vials | 25 Million |
| Ampoules | 60 Million |
| Powder For Injections | 10 Million |
| Lyophilized products | 6.0 Million |
| Liquid Vials | 25 Million |
| Ampoules | 60 Million |
| Powder For Injections | 10 Million |
| Lyophilized products | 6.0 Million |
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Our International Business Development Team delivers on 24hrs turnaround for all RFQs
Frequently Asked Questions
- What documentation support is provided for special import and product registration?
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Yes, we have inhouse regulatory team that will support you with COA, WHO-GMP, CoPP for special import and also provide dossiers as per the requirement of regulatory authority for product registrations.
- Is it possible to have customised packaging for the products we require?
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Yes, we have inhouse design team that will understand your preference and workout customised packaging for the pharmaceutical products.
- Do you provide port to port shipping services?
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Yes, we will take over all the hassle and provide you quotes as per the mode of transport preffered by the customer for port to port shipments.
- Do you provide Door to Door shipping services?
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We have tie ups with international companies like DHL, FedEx, United Parcel Service etc to provide door to door shipping services for the customers who has stringent lead times at affordable shipment rates via air.
- What If the product requires a Validated cold chain?
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With shifting of pharma industry from synthetic molecules to biologic, proteins etc. temperature maintenance has become as important as the drug itself! According to the WHO – Good Distribution Practices, certain medicines need to be manufactured transported and stored at very specific temperatures. Cold chains is thus a supply chain management process that involves storage and transportation of temperature-sensitive goods (such as vaccines, serums, biological, and test samples) from the time they are manufactured until the time they are used, utilizing thermal and refrigerated packaging methods to help with transportation. SiNi Pharma Pvt. Ltd. has undergone thorough validation of it’s cold chain process as per WHO GDP guidelines and our practices are best in Industry from India.
- Can you supply directly to Hospitals, Institutions & NGO?
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SiNi Pharma Pvt. Ltd. have access to supply, Generics, Super speciality or Speciality medicines used in a treatment of Cancer, HIV/AIDS, Blood disorders, Kidney problems, Heart disorder, Bone-related issues, Nerve disorders, Respiratory Syndromes, Organ Transplant, Immunological disorders, viral etc directly to Hospitals, Institutions & NGO. Our product range includes Life-saving medicines, Orphan drugs/Rare Disease medicines, Over the counter (OTC) medicines & Vaccines to supply private or government hospitals, tenders, NGO’s/Charity & patient in the international market.