Contract Manufacturing
Sigma Softgel & Formulation is a new-age manufacturer of soft gelatin capsules for
• Rx
• OTC and
• Nutraceuticals
To cater to the growing needs of Pharmaceutical Companies worldwide, Softgel has newly set up an advanced manufacturing plant with state-of-the-art machineries and technically skilled personnel.
Sigma Softgel & Formulation is well-defined orgonogram and skilled manpower to be a leading name in the manufacture of soft gelatin capsules.
Sigma Softgel & Formulation aims to provide its customers with Novel Drug Delivery Systems and services including formulation development, Analytical method development and stability studies. The Tests are carried at par with highest standards of quality, reliability and compliance. Sigma’s Success is the result of focusing on clients requirements at affordable cost & consistent quality. Customer Satisfaction / Service is on the priority list and it understands that the Association should result in its own growth and also the success of the clients.
Sigma Softgel & Formulation is committed to better healthcare for all, through quality products, achieved through manufacturing excellence, compliance to requirements and continual improvement in quality management system, for maximum customer satisfaction. Giving utmost importance to quality, Sigma Softgel & Formulation has developed a sophisticated system and seamless procedure throughout the organization. This minimizes risk and enables us to produce superior quality products.
Sigma Softgel & Formulation implements an unmatched global quality management system that is based on the desire to sustain a culture of operational excellence. Our company’s passion for quality goes way beyond business and statutory requirements. Sigma Softgel & Formulation has reliable standards and is a manufacture of best quality products that satisfy norms set by all multinationals and large pharmaceutical houses, qualifying for international and national sales.
The success Mantras of Sigma.
Long-term Business Tip-ups.
Continuous development of Innovative Formulations.
Keeping abreast with Global developments and providing the same in Domestic Market.
Elite group of Professionals with rich experience.
Frequent New Launches of DGCI Approved Products.
Customer centric and Service oriented approach.
Meeting timeliness, following Manufacturing requirements, analyzing to understand the Market / Marketing Research Analysis.
Forecasting Patient Needs.
Developing Formulations as per requirement and assisting companies to fulfill the patient’s requirement.
Our strengths are as follows:-
First time in India launches.
Innovative formulations.
Manufacturing Brand Leaders
DCGI APPROVED PRODUCTS
Dedicated Hormonal Block
In-House Testing with a well experienced Qualified and Competent Technical Personnel in Q.A, Q.C & Production
In-House packaging Development & Production
Exclusive Tie-up with API Vendors to have uninterrupted Production & Supply
Efficient Logistic Department for on time dispatch & deliveries.
Large Storage Capacity to Hold Finished Goods
Plant Located in a well surrounded atmosphere appropriate for production.
Key Features
Eco-friendly design of building and premises
Latest and best-in-class HVAC, water and other utility systems
Effective water and waste management systems
Good Manufacturing Process Records
An area of over 1200sq. meters with dedicated buildings for manufacturing, office and utility spaces
Separate entries for each production area for man and material based on unidirectional flow concept
Over 10,000sq.ft. area earmarked for Quality Control (QC) and Quality Assurance (QA) activities
PROCESS OF THIRD PARTY MANUFACTURING
1. FINALIZING ORDER QUANTITY AND COMPOSITION.
Before starting the process of third party contract manufacturing, we have to finalize order quantity and composition of the product. While concluding the order quantity, we have to keep in mind minimum order quantities for the composition. For Soft gelatin capsules, MOQ is usually between 50000 – 100000 units of Caps . While finalizing we have to check if the manufacturer has an approval for that composition.
2. RAISING QUOTATION.
After finalizing composition and order quantities for contract manufacturing. We will raise a quotation which will include all the costs that you will incur. A quotation includes cost of product, packaging material, securities if any in case of smaller batches. It also includes any other charges that you would have to pay for the contract manufacturing process.
3. REQUIRED DUCOMENTS.
To get a product made you need several documents. Some basic documents include Drug license and GST number. In some cases you will also require registration document of your firm or company. DL is issued by your local Food and Drug authorities. DL is of 2 types, one for retail and other for wholesale. GST number is issued by Government of India and is required for Third party manufacturing. In some cases some other documents like NON RESEMBLANCE CERTIFICATE and agreement for contract manufacturing are needed.
4. PACKING MATERIAL.
Promotional materials are used in every day sales by the medical representatives. Packing materials are the most proven marketing strategies. We always prefer best quality packing material by using all printing techniques.
5. PRODUCT MANUFACTURING.
There are certain quality standards set in GMP the production unit having the GMP certification, has to follow the guidelines set by GMP while manufacturing. GMP is a system that ensures the product is constantly produced and controlled according to the quality standards. GMP covers all the aspects of production from starting material to the hygienic staff. Every time products are made the correct procedure must be followed at each step.
6. PRODUCT DELIVERY.
On-time delivery (OTD) is one of contract manufacturing’s most common measurements, On time delivery is a measure of process and supply chain efficiency which measures the amount of finish goods or services delivered to customers on time and in full. It helps determine how efficiently we are meeting our customer’s or agreed deadlines. It is an important priority to everyone in the business today.