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PALE-40 Clinical Monograph & Batch COA

Certified DCGI Formulation Literature (PDF)

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InjectionPrescription Required (Schedule Drug)

PALE-40

Name: PALE-40
Brand: Sygnus Biotech

Active Drug Composition

Pantoprazole Sodium 40mg

WHO-GMP Certified Batch ManufacturingDCGI Approved Formulation100% BioavailableAlu-Alu Packaging

PALE-40 is an advanced gastro-protective formulation developed for the rapid healing of mucosal erosion, acid peptic disorders, and gastroesophageal reflux disease (GERD).

Dosage FormSterile Injectable (I.V. / I.M.)

Packaging PresentationSingle Dose Sterile Vial with Ampoule & WFI

B2B Distributor & Healthcare Professional Notice:This product is supplied solely through verified licensed pharmaceutical distributors, stockists, and institutional tenders. Online retail checkout for prescription formulations is legally restricted.

Clinical Pharmacology & Therapeutic Profile

Comprehensive therapeutic guidelines for medical practitioners and institutional procurement

Therapeutic Indications

Peptic Ulcer Disease

Duodenal Ulcers

Acid Reflux & GERD

Gastritis & Mucosal Inflammation

Stress Ulcer Prophylaxis

Mechanism of Action (MOA)

Forms a polyanionic protective barrier coating over inflamed gastric ulcers, preventing enzymatic acid degradation while facilitating tissue re-epithelialization.

Dosage & Posology

Administer on an empty stomach 1 hour before principal meals, or as posology prescribed by the gastroenterologist.

Safety & Precautions

Well tolerated under clinical supervision. Contraindicated in patients with hypersensitivity to active ingredients.

Storage Guidelines

Store between 2°C to 8°C or below 25°C as indicated on label. Protect from light.

WHO-GMP Certified Purity

Manufactured in state-of-the-art HVAC controlled cleanrooms with 100% active ingredient bio-potency and analytical batch testing.

Alu-Alu Moisture Barrier

Superior barrier protection against tropical humidity, preventing physical degradation and guaranteeing 24-month stability.

Exclusive District Monopoly

Strict PCD franchise monopoly allocation ensuring zero price competition and complete territory protection for our partners.

Technical Product Specifications

Therapeutic SegmentInjection

Dosage FormSterile Injectable (I.V. / I.M.)

Packaging TypeSingle Dose Sterile Vial with Ampoule & WFI

Regulatory ScheduleSchedule H1 Prescription Drug

Minimum Order Qty100 Units

Country of OriginIndia (Sidhpur Facility)

Quality StandardWHO-GMP & ISO 9001:2015

Batch Analytical COASupplied with Trade Invoice

Active Medical Composition

PALE-40 features Pantoprazole Sodium 40mg prepared to high pharmaceutical purity standards.

Therapeutic ClassificationInjection

Regulatory ScheduleSchedule Drug (Prescription Only)

*Disclaimer: Formulations are intended solely for distribution to licensed practitioners, hospitals, and pharmacies. Dosage must adhere to medical advice.

Monopoly PCD Franchise

Apply for Exclusive Marketing Rights of PALE-40

Check vacant territory availability in your state or district. Enjoy full marketing kit support, visual aids, and guaranteed zero competitor supply.

Distributor Inquiries

Questions Regarding PALE-40

What is the therapeutic indication and composition of PALE-40?

PALE-40 contains Pantoprazole Sodium 40mg indicated for Peptic Ulcer Disease as formulated by Sygnus Biotech.

What packaging presentations are available for PALE-40?

PALE-40 is supplied in tamper-evident Single Dose Sterile Vial with Ampoule & WFI, engineered with barrier foil protection to ensure a 24 to 36 month shelf life.

Is monopoly PCD franchise territory available for PALE-40?

Yes, Sygnus Biotech grants exclusive district-wise monopoly marketing rights for PALE-40 along with promotional visual aids, product cards, and marketing support.