Top Parenterals Manufacturer in India

Top Parenterals Manufacturer in India – Sigma Softgel & Formulation

India is a global hub for pharmaceutical manufacturing, and among its specialties, parenteral formulations stand out as a cornerstone of advanced drug delivery. Parenterals are sterile pharmaceutical products administered through injection or infusion, bypassing the gastrointestinal tract for rapid and effective treatment. In this vital segment, Sigma Softgel & Formulation emerges as one of the leading parenterals manufacturers in India, offering world-class sterile products backed by stringent quality control and cutting-edge technology.

What are Parenterals?

Parenterals are medications delivered via injections, infusions, or sterile solutions into the body, typically through:

• Intravenous (IV)

• Intramuscular (IM)

• Subcutaneous (SC)

• Intradermal (ID)

These formulations are used when:

• Fast therapeutic action is needed

• The drug is not effective orally

• Precise dosage control is critical

• Sterile administration is required

Sigma Softgel – Trusted Name in Parenteral Manufacturing

About the Company

Located in Baddi, Himachal Pradesh, Sigma Softgel is a WHO-GMP and ISO 9001:2015 certified pharmaceutical manufacturing company with a strong presence in domestic and international markets. Sigma specializes in the manufacturing of parenteral dosage forms, offering a wide range of sterile injectable products, infusions, WFI (Water for Injection), and respules for various therapeutic segments.

Parenteral Dosage Forms Offered by Sigma Softgel

1. Liquid Injections (Small Volume Parenterals)

Sterile injectable liquids in ampoules and vials, available in:

• 1 ml, 2 ml, 5 ml, 10 ml formats

• Single and multi-dose vials

• Glass and plastic ampoules

Common formulations include:

• Diclofenac Sodium Injection

• Ceftriaxone Injection

• Pantoprazole Injection

• Ondansetron Injection

• Dexamethasone Injection

2. Large Volume Parenterals (LVPs) – Infusions

Sterile IV infusions produced in FFS (Form Fill Seal) bottles or glass bottles, including:

• Dextrose 5%, 10%

• Normal Saline

• Ringer Lactate

• DNS (Dextrose + Saline)

• Mannitol Infusion

These are crucial for rehydration, electrolyte balance, and IV drug administration.

3. Dry Powder Injections

Sterile powder packed in vials to be reconstituted before use:

• Ceftriaxone + Sulbactam

• Cefoperazone + Sulbactam

• Piperacillin + Tazobactam

Ideal for antibiotic therapies in hospitals and ICUs.

4. Water for Injection (WFI)

• Sterile WFI in ampoules/vials

• Used as a diluent for reconstitution

• Manufactured in fully automated aseptic conditions

5. Respules (Nebulization Units)

Single-use sterile solutions for inhalation, commonly used in respiratory treatments:

• Salbutamol Respules

• Budesonide Respules

• Ipratropium Bromide Respules

World-Class Manufacturing Infrastructure

Sigma Softgel’s parenteral unit is designed to meet international regulatory requirements, featuring:

• Sterile and cleanroom zones with advanced HVAC systems

• Aseptic filling lines for ampoules, vials, and infusions

• FFS (Form-Fill-Seal) technology

• Autoclaves, sterilizers, and terminal sterilization setups

• Microbiological and chemical testing labs

• Water purification systems (RO + EDI + UV)

All manufacturing is done under controlled and monitored conditions to ensure sterility, safety, and efficacy.

Quality Control & Regulatory Compliance

At Sigma Softgel, every batch undergoes rigorous QC and QA checks, including:

• Sterility testing

• Particulate matter test

• pH and isotonicity checks

• Endotoxin (pyrogen) testing

• Shelf-life and stability studies

Certifications include:

• WHO-GMP Compliance

• ISO 9001:2015

• DCGI-approved product list

• Export capability with documentation support

Contract Manufacturing of Parenterals

Sigma Softgel offers third-party manufacturing and contract manufacturing services for parenteral products, including:

• Custom formulation development

• Branding and packaging support

• Private labelling

• Product registration assistance

• Logistics and timely delivery

The company is a preferred partner for startups, pharma brands, hospitals, and institutional buyers.

Therapeutic Segments Served

Sigma Softgel manufactures parenterals for multiple therapeutic areas:

• Antibiotics & Antimicrobials

• Pain Management

• Gastrointestinal

• Cardiovascular

• Respiratory Care

• Electrolyte Replacement

• Critical Care and ICU

Why Choose Sigma Softgel as Your Parenteral Manufacturing Partner?

✅ WHO-GMP Certified Parenteral Unit
✅ Full Range: Injectables, Infusions, WFI, Respules
✅ Sterile Manufacturing with Aseptic Processing
✅ DCGI-Approved Product Portfolio
✅ Competitive Pricing with MOQ Flexibility
✅ Fast Turnaround Time and On-Time Delivery
✅ Export-Ready Products and Documentation Support