Comprehensive Packaging Specifications of LEVOFLOXACIN HEMIHYDRATE (CAS No. 138199-71-0) by Swapnroop Drugs & Pharmaceuticals Ask ChatGPT

Q1: What is LEVOFLOXACIN HEMIHYDRATE manufactured by Swapnroop Drugs & Pharmaceuticals?

Levofloxacin Hemihydrate is a pharmaceutical active pharmaceutical ingredient (API) that belongs to the class of fluoroquinolone antibiotics. It is a synthetic broad-spectrum antibacterial agent used to treat various bacterial infections. The hemihydrate form indicates that the molecule is crystallized with half a molecule of water per molecule of levofloxacin, which is important for stability, purity, and formulation characteristics.

🔬 Basic Chemical Information

Property	Details
API Name	Levofloxacin Hemihydrate
Molecular Formula	C₁₈H₂₀FN₃O₄ • 0.5H₂O
Molecular Weight	Approx. 370.38 g/mol (anhydrous), ~ 378.4 g/mol (hemi)
Chemical Name (IUPAC)	(S)-9-fluoro-2,3-dihydro-3-methyl-10-(4-methylpiperazin-1-yl)-7-oxo-7H-pyrido[1,2,3-de][1,4]benzoxazine-6-carboxylic acid hemihydrate
CAS Number	138199-71-0
UNII (FDA)	4983Y76OT1
ATC Code	J01MA12 (systemic use)

🧪 Physical and Chemical Characteristics

Appearance: White to pale yellowish-white crystalline powder.
Solubility: Freely soluble in water; practically insoluble in ether and chloroform.
pH (1% solution): ~4.0 to 6.5
Melting Point: ~225–230°C (decomposes)
Optical Rotation: Specific for levo- (S)-enantiomer; optically active.

🧬 Nature and Function

Levofloxacin is the L-isomer of ofloxacin, and is approximately twice as potent as the racemic mixture. As a fluoroquinolone, it works by inhibiting bacterial DNA gyrase and topoisomerase IV, enzymes essential for bacterial DNA replication, transcription, repair, and recombination.

🏭 Manufacturing by Swapnroop Drugs & Pharmaceuticals

While specific proprietary process details from Swapnroop are not publicly available, the manufacturing generally involves:

Crystallization of levofloxacin base with controlled hydration conditions to form the hemihydrate.
Purification via solvent methods to ensure pharmaceutical grade.
Particle size reduction and drying under GMP conditions.
QC testing for identity, assay, water content, microbial limits, residual solvents, etc.

Swapnroop Drugs & Pharmaceuticals would typically produce this API under cGMP standards to supply to formulators for tablets, injections, and ophthalmic solutions.

🧾 Summary

Levofloxacin Hemihydrate (CAS No. 138199-71-0) is a broad-spectrum fluoroquinolone antibacterial API used in the treatment of respiratory tract infections, urinary tract infections, skin infections, and more. It is manufactured in a stable crystalline form (hemihydrate) for use in pharmaceutical dosage forms. Swapnroop Drugs & Pharmaceuticals is likely to supply this API in compliance with pharmacopeial standards (IP/BP/USP/EP), depending on regulatory requirements.

Q2: What is LEVOFLOXACIN HEMIHYDRATE by Swapnroop Drugs and Pharmaceuticals used for?

Levofloxacin Hemihydrate, manufactured by Swapnroop Drugs & Pharmaceuticals, is used as an active pharmaceutical ingredient (API) in various dosage forms to treat a broad range of bacterial infections. It is the hemihydrate form of levofloxacin, which is a third-generation fluoroquinolone antibiotic and the active L-isomer of ofloxacin. It exhibits potent bactericidal activity against both Gram-positive and Gram-negative pathogens.

✅ Therapeutic Uses

Levofloxacin Hemihydrate is primarily used in the treatment of:

Infection Type	Examples
Respiratory Tract Infections	Pneumonia (including community-acquired and nosocomial), acute sinusitis, chronic bronchitis
Urinary Tract Infections (UTIs)	Complicated and uncomplicated UTIs, pyelonephritis
Skin and Soft Tissue Infections	Cellulitis, wound infections, abscesses
Prostatitis	Bacterial prostatitis (chronic and acute)
Gastrointestinal Infections	Traveler’s diarrhea, infections caused by Salmonella
Anthrax (post-exposure)	As prophylaxis following inhalational exposure
Eye infections (when in ophthalmic form)	Bacterial conjunctivitis

💊 Mechanism of Action

Levofloxacin inhibits DNA gyrase (topoisomerase II) and topoisomerase IV, enzymes critical to bacterial DNA replication, transcription, repair, and recombination. The inhibition leads to rapid bacterial cell death.

Bactericidal rather than bacteriostatic.
Time-dependent killing with a concentration-dependent component.

🔄 Spectrum of Activity

Levofloxacin is active against:

Gram-negative bacteria: Escherichia coli, Klebsiella pneumoniae, Pseudomonas aeruginosa
Gram-positive bacteria: Streptococcus pneumoniae, Staphylococcus aureus (MSSA), Enterococcus faecalis
Atypicals: Mycoplasma pneumoniae, Chlamydophila pneumoniae, Legionella pneumophila

Note: Resistance patterns should be monitored; fluoroquinolone resistance is emerging in some regions.

❖ Q3: What are the physicochemical properties of LEVOFLOXACIN HEMIHYDRATE manufactured by Swapnroop Drugs and Pharmaceuticals?

Physicochemical properties are essential to ensure the quality, stability, formulation compatibility, and bioavailability of the API.

📊 Physicochemical Profile

Property	Details
Chemical Name	(S)-9-fluoro-2,3-dihydro-3-methyl-10-(4-methylpiperazin-1-yl)-7-oxo-6-fluoroquinoline-6-carboxylic acid hemihydrate
Molecular Formula	C₁₈H₂₀FN₃O₄ · 0.5H₂O
Molecular Weight	~378.4 g/mol (hemihydrate)
CAS Number	138199-71-0
Appearance	White to pale yellowish-white crystalline powder
Melting Point	~225–230°C (decomposes)
Solubility	Freely soluble in water, practically insoluble in ethanol, methanol, and chloroform
pH of 1% solution	Typically 4.0–6.5
Specific Rotation	Confirming enantiomeric purity of S-isomer
Polymorphism	Known to exist in different crystalline forms; hemihydrate form is stable
Log P (octanol/water)	~ -0.4 (hydrophilic nature)
UV Absorption	λmax around 290–300 nm (used for analytical assay)

📦 Key Notes for Manufacturing

Stability: Hemihydrate is more stable than monohydrate or anhydrous forms under ambient storage.
Hydration state: Critical for bioequivalence and product consistency.
Flowability: Good for tableting or capsule filling processes after granulation.

Q4: How is LEVOFLOXACIN HEMIHYDRATE manufactured by Swapnroop Drugs and Pharmaceuticals synthesized?

Levofloxacin Hemihydrate is synthesized through a chiral-specific synthesis starting from racemic ofloxacin or other quinolone intermediates. The goal is to produce only the S-enantiomer (levofloxacin), which has higher antimicrobial activity and lower toxicity than the racemic ofloxacin.

🏭 General Synthetic Route of Levofloxacin Hemihydrate

Note: The actual process used by Swapnroop Drugs & Pharmaceuticals may vary and could involve patented or proprietary improvements, but the general industry method is outlined below:

🔬 Step-by-Step Synthesis Outline

Preparation of the key quinolone intermediate:
- Starting from ethyl 1,4-dihydro-4-oxoquinoline-3-carboxylate.
- Fluorination at position 6 and substitution at position 7 with piperazine derivative.
- Introduction of methyl at position 3 and carboxylic acid at position 6.
Chiral resolution or asymmetric synthesis:
- If racemic ofloxacin is used, chiral resolution is performed using optically active resolving agents (e.g., tartaric acid derivatives).
- Alternatively, an enantioselective synthesis using chiral catalysts or precursors can be employed to directly yield (S)-levofloxacin.
Conversion to Levofloxacin free base:
- The resolved or synthesized (S)-levofloxacin is isolated as a free base and then purified.
Crystallization as Hemihydrate:
- The free base is treated with water under controlled temperature and pH conditions to form a stable hemihydrate crystal.
- This step is critical for achieving proper polymorph (crystal form), which affects solubility and stability.
Drying and Micronization:
- The hemihydrate is dried at low temperatures to avoid loss of water of hydration.
- Micronization (if needed) is done to achieve proper particle size distribution for pharmaceutical formulation.

⚗️ Reaction Type Summary

Type of Synthesis: Chiral (either resolution or asymmetric)
Reactions involved: Cyclization, fluorination, amination, methylation, carboxylation
Purification: Crystallization, filtration, washing, drying

❖ Q5: What are the different dosage forms of LEVOFLOXACIN HEMIHYDRATE manufactured by Swapnroop Drugs and Pharmaceuticals?

Swapnroop Drugs & Pharmaceuticals, as a manufacturer of Levofloxacin Hemihydrate API, may supply this to various formulation companies or manufacture formulations in-house (if they are vertically integrated).

Here are common dosage forms in which Levofloxacin Hemihydrate is formulated:

💊 1. Oral Solid Dosage Forms

Dosage Form	Strengths (Typical)	Use
Tablets	250 mg, 500 mg, 750 mg	Systemic infections
Capsules	Less common	Oral therapy
Dispersible Tabs	Pediatric applications	Pediatric infections

💉 2. Injectable Dosage Forms

Dosage Form	Concentration	Notes
IV Infusion	5 mg/mL (in 100 mL or 150 mL)	Hospital use
Lyophilized Powder	For reconstitution	Used in critical care

👁️ 3. Ophthalmic Dosage Forms

Dosage Form	Strength	Indication
Eye Drops	0.5% or 1%	Bacterial conjunctivitis, keratitis

💧 4. Otic (Ear) Drops

Typically used for ear infections (e.g., otitis externa)

🧴 5. Topical Gels or Creams (less common)

Investigational or limited use in dermal infections

📦 Summary Table

Dosage Form	Route	Indications
Tablets	Oral	Respiratory, UTI, Skin, GI
Infusion	IV	Serious systemic infections
Eye Drops	Ophthalmic	Conjunctivitis, eye infections
Ear Drops	Otic	Otitis externa, media
Pediatric Formulations	Oral	Pediatric infections

Q6: How are LEVOFLOXACIN HEMIHYDRATE dosage forms manufactured by Swapnroop Drugs and Pharmaceuticals prepared?

The preparation of dosage forms from Levofloxacin Hemihydrate API involves formulation, granulation (if solid), sterilization (if injectable), and packaging steps. The process depends on the route of administration and the type of formulation—oral, injectable, ophthalmic, or otic.

Below is a breakdown of how various dosage forms are prepared using Levofloxacin Hemihydrate:

💊 1. Oral Tablets (250 mg / 500 mg / 750 mg)

🧪 Formulation Steps:

Blending:
- Mix Levofloxacin Hemihydrate with excipients like:
  - Diluents: Microcrystalline cellulose, lactose
  - Disintegrants: Crospovidone, sodium starch glycolate
  - Binders: Povidone K30
  - Lubricants: Magnesium stearate
Wet or Dry Granulation:
- Wet granulation involves adding a binder solution to form granules.
- Dry granulation is used when Levofloxacin is moisture-sensitive.
Compression:
- Granules are compressed into tablets using a rotary tablet press.
Film Coating (optional):
- Film coating with polymers (e.g., HPMC) improves appearance, taste masking, and stability.

💉 2. Intravenous Infusion (5 mg/mL)

🧪 Preparation Process:

Dissolution:
- Levofloxacin Hemihydrate is dissolved in water for injection.
- pH adjusted using NaOH or HCl (target pH: 4.5–5.5).
Filtration:
- The solution is passed through 0.22-micron sterilizing filters.
Filling:
- Aseptic filling into infusion bags or vials under GMP sterile conditions.
Sterilization:
- If needed, the filled containers are sterilized via autoclaving (121°C for 15–20 mins).

👁️ 3. Eye Drops (0.5% or 1%)

🧪 Manufacturing Steps:

Dissolution:
- Dissolve Levofloxacin Hemihydrate in sterile purified water.
- Add buffering agents (e.g., boric acid) and preservatives (e.g., benzalkonium chloride).
pH Adjustment:
- Adjust to ~pH 6.5–7.0.
Sterile Filtration:
- Filtered through 0.22 µm filter.
Aseptic Filling:
- Filled into sterilized dropper bottles.

🧴 4. Oral Suspension (Pediatric)

API is micronized and mixed with:
- Suspending agents: Xanthan gum, sodium CMC
- Sweeteners: Sorbitol, sucrose
- Flavorings and preservatives
Homogenization to form a uniform suspension.
Bottling under sterile or cleanroom conditions.

❖ Q7: What is the appropriate dosage form of LEVOFLOXACIN HEMIHYDRATE manufactured by Swapnroop Drugs and Pharmaceuticals?

The appropriate dosage form of Levofloxacin Hemihydrate depends on the type, severity, and location of infection, as well as patient age and clinical condition.

✅ Recommended Dosage Forms by Indication:

Indication	Preferred Dosage Form	Rationale
Community-acquired pneumonia	Oral tablets or IV infusion	Systemic therapy needed
Urinary tract infections (UTIs)	Oral tablets	High renal excretion of drug; oral route effective
Skin & soft tissue infections	Oral tablets or IV	Moderate to severe infections
Acute sinusitis / bronchitis	Oral tablets	Convenient for outpatient care
Severe or hospitalized infections	IV infusion	Immediate systemic levels needed
Pediatric infections	Oral suspension	Suitable for age, dosing flexibility
Eye infections (e.g. conjunctivitis)	Ophthalmic eye drops (0.5–1%)	Local targeted delivery
Otitis externa (ear infection)	Otic drops	Local therapy; minimal systemic absorption

📌 Summary

Oral Tablets: Most commonly used, effective for most indications.
IV Infusion: For hospitalized or serious infections.
Eye Drops: For localized eye infections.
Suspension: Pediatric or dysphagic patients.

Here are detailed answers to:

❖ Q8: When should LEVOFLOXACIN HEMIHYDRATE API manufactured by Swapnroop Drugs and Pharmaceuticals be taken?

Levofloxacin Hemihydrate, when formulated into tablets, infusions, or suspensions, should be taken based on the type of infection, patient condition, and formulation type. As an API, it is not directly administered but formulated into dosage forms. However, its pharmacokinetics and clinical guidelines determine when and how the formulations should be used.

🕒 General Guidelines for Dosing Timing

Dosage Form	Timing
Oral Tablets/Suspension	Once daily or twice daily (depending on dose)
IV Infusion	Typically once every 24 hours
Ophthalmic Drops	Every 2 hours initially, then 4x daily (as directed)

⏰ Timing Considerations

With or Without Food:
- Levofloxacin oral formulations can be taken with or without food.
- Avoid antacids, calcium, magnesium, zinc, or iron supplements within 2 hours before or after dosing, as they reduce absorption.
Consistency:
- Take the dose at the same time each day to maintain steady plasma levels.
Duration of Therapy:
- Usually 5–14 days, depending on the infection.
- Do not skip doses or stop early, even if symptoms improve.
Renal Function Adjustment:
- Dosage and frequency may need to be adjusted in patients with impaired kidney function, as levofloxacin is primarily excreted via the kidneys.

🧠 Key Pharmacokinetic Info:

Parameter	Value
Half-life	~6–8 hours
Bioavailability	>99% (oral)
Time to peak	1–2 hours (oral)
Protein binding	~30–40%
Excretion	Mainly renal (~87% unchanged)

❖ Q9: What are the effects and side effects of LEVOFLOXACIN HEMIHYDRATE manufactured by Swapnroop Drugs and Pharmaceuticals?

Levofloxacin Hemihydrate exerts its therapeutic effects by inhibiting bacterial DNA replication, making it highly effective against a wide range of infections. However, like all fluoroquinolones, it is associated with both common and rare but serious side effects.

✅ Therapeutic Effects (Desired)

Bactericidal activity against a broad spectrum
Rapid clinical improvement in:
- Respiratory tract infections
- Urinary tract infections
- Skin infections
- Eye and ear infections
High tissue penetration and excellent bioavailability

⚠️ Common Side Effects

System	Adverse Effects
Gastrointestinal	Nausea, diarrhea, vomiting, abdominal pain
Central Nervous System	Headache, dizziness, insomnia, anxiety
Musculoskeletal	Tendonitis, joint pain, muscle pain
Dermatologic	Rash, itching, photosensitivity
General	Fatigue, taste disturbance

⚠️ Serious (but less common) Side Effects

Fluoroquinolones carry a black box warning in several countries (including the U.S.) for the following:

Condition	Description
Tendon rupture	Especially Achilles tendon, in elderly or steroid users
Peripheral neuropathy	Long-term or irreversible nerve damage
CNS effects	Seizures, tremors, hallucinations
QT prolongation	Risk of arrhythmia, especially when combined with other QT-prolonging drugs
Hypersensitivity reactions	Stevens-Johnson Syndrome, anaphylaxis (rare)
Hepatotoxicity	Liver enzyme elevations, rare liver injury
Dysglycemia	Hyperglycemia or hypoglycemia, especially in diabetics

🚫 Contraindications

History of hypersensitivity to levofloxacin or other quinolones
Children/adolescents (unless benefits outweigh risks)
Pregnancy and breastfeeding (use only if necessary)

Q10: How is LEVOFLOXACIN HEMIHYDRATE manufactured by Swapnroop Drugs and Pharmaceuticals tested?

Levofloxacin Hemihydrate manufactured by Swapnroop Drugs & Pharmaceuticals undergoes rigorous quality control (QC) and quality assurance (QA) processes to comply with pharmacopeial standards (e.g., USP, EP, IP).

🧪 Testing Stages in Manufacturing

Stage	Purpose
Raw Material Testing	Verify identity, purity, and suitability of starting materials.
In-Process Testing	Monitor critical parameters like pH, water content, and crystallinity.
Finished API Testing	Ensure final product meets pharmacopeial specifications.
Stability Testing	Check for changes over time under different environmental conditions.

🧬 Common Testing Methods

Identity Testing
- IR Spectroscopy: Confirms functional groups.
- HPLC with UV detection: Compares retention time with standard.
- Specific Rotation: Confirms chiral (S)-enantiomer.
Assay (Potency Determination)
- HPLC (High Performance Liquid Chromatography): Quantifies % content of Levofloxacin.
Water Content
- Karl Fischer titration: Critical for hemihydrate form.
Related Substances (Impurities)
- HPLC: Checks for degradation products and process impurities.
Heavy Metals / Elemental Impurities
- ICP-MS or AAS methods per ICH Q3D.
Residual Solvents
- GC (Gas Chromatography): Detects Class 1, 2, and 3 solvents.
Polymorph/Crystallinity
- XRPD (X-ray Powder Diffraction) or DSC (Differential Scanning Calorimetry).
Particle Size Analysis (if applicable)
- Laser diffraction: Affects dissolution and bioavailability.
Microbial Limits (if sterile grade)
- Bioburden & endotoxin testing (for parenterals).
pH and Appearance
- Especially for solutions and suspensions.

❖ Q11: What tests are performed on LEVOFLOXACIN HEMIHYDRATE manufactured by Swapnroop Drugs and Pharmaceuticals?

Below is a summary of the standard QC tests typically performed on the final API:

Test	Method / Standard
Description	Visual observation
Identification	IR, UV, HPLC
Assay	HPLC (should meet 98.0–102.0% of label)
Water Content	Karl Fischer (≤4.0% typically for hemihydrate)
pH (1% solution)	pH meter (~4.0–6.5)
Specific Optical Rotation	Polarimetry (confirms S-enantiomer)
Related Substances / Impurities	HPLC, Limit: NMT 0.5% individual, 1.0% total
Residual Solvents	GC-FID, per ICH Q3C
Heavy Metals / Elemental Impurities	ICP-MS or AAS (per ICH Q3D)
Particle Size Distribution	Laser diffraction (D90 control)
Polymorphic Form	XRPD, DSC
Microbial Limit (if sterile)	Total aerobic count, endotoxins
Stability Studies	As per ICH Q1A (accelerated and long-term)

The exact tests and limits are specified in the Certificate of Analysis (CoA) and Drug Master File (DMF).

❖ Q12: What are the challenges in manufacturing LEVOFLOXACIN HEMIHYDRATE API by Swapnroop Drugs and Pharmaceuticals?

Producing high-quality Levofloxacin Hemihydrate API involves several technical, regulatory, and operational challenges:

🏭 Key Manufacturing Challenges

Chiral Purity Control
- Must isolate (S)-levofloxacin with minimal R-enantiomer contamination.
- Requires efficient resolution or asymmetric synthesis.
Crystallization of Hemihydrate Form
- Achieving and maintaining consistent hydration level.
- Incorrect crystal form affects stability and dissolution.
Polymorphism Control
- Levofloxacin can exist in multiple polymorphs.
- Only specific polymorphs may be acceptable for regulatory filing.
Water Content & Hygroscopicity
- Hemihydrate form can lose or absorb water, changing its physical properties.
- Controlled humidity and drying processes are essential.
Impurity Management
- Fluoroquinolone synthesis can produce toxic impurities (e.g., fluorinated organics).
- Must be rigorously controlled as per ICH Q3A/Q3B.
Residual Solvents
- Solvent recovery and removal must meet ICH Q3C limits.
- Class 2 solvents often used in chiral separation steps.
Environmental and Safety Concerns
- Handling of fluorinated intermediates and strong acids/bases poses risks.
- Requires EHS compliance for emissions and effluents.
Regulatory Compliance
- Must meet GMP, USFDA, EDQM, PMDA, or other national standards.
- Requires well-documented process validation and control strategy.
Scalability of Chiral Process
- Lab-scale enantioselective processes may not scale efficiently.
- High yield + low cost + reproducibility needed at plant level.

Q13. What are the challenges in manufacturing LEVOFLOXACIN HEMIHYDRATE API by Swapnroop Drugs & Pharmaceuticals?

Challenges in API manufacturing of LEVOFLOXACIN HEMIHYDRATE:

Polymorphism Control:
LEVOFLOXACIN exists in multiple polymorphic forms; controlling the specific hemihydrate form is essential for consistent solubility and bioavailability.
Hydration State Stability:
Maintaining the hemihydrate form during synthesis and drying is technically challenging. Slight process changes can cause dehydration or conversion to an anhydrous form.
Stereochemistry:
LEVOFLOXACIN is the S-enantiomer of ofloxacin, so its synthesis must ensure enantiomeric purity (>99%). Chiral resolution or asymmetric synthesis methods must be tightly controlled.
Crystallization Consistency:
Achieving consistent crystal morphology and particle size distribution is crucial for downstream formulation and dissolution properties.
Environmental Sensitivity:
Being a fluoroquinolone, it is light-sensitive and prone to photodegradation, requiring careful handling under controlled lighting.
Impurity Profile Control:
The presence of residual solvents, inorganic impurities, and synthetic byproducts (e.g., fluoroaromatic impurities) must be tightly controlled as per ICH Q3 guidelines.

Q14. What are the challenges in manufacturing LEVOFLOXACIN HEMIHYDRATE dosage forms by Swapnroop Drugs & Pharmaceuticals?

Challenges in dosage form manufacturing:

API Solubility and Stability:
While LEVOFLOXACIN is moderately water-soluble, ensuring complete dissolution in aqueous systems (especially for oral solutions or IV forms) without degradation is challenging.
Hygroscopic Nature:
The hemihydrate form can absorb moisture from the environment, impacting tablet hardness, disintegration, and shelf life.
Tablet Compression Issues:
The crystalline form of the API may lead to poor flow or compaction properties, necessitating granulation or use of suitable excipients.
Taste Masking (for oral suspensions or dispersible tablets):
LEVOFLOXACIN has a strong bitter taste, and adequate masking is critical, especially in pediatric formulations.
Compatibility with Excipients:
Fluoroquinolones can interact with metal ions and divalent cations. Proper excipient selection (avoiding magnesium/calcium stearates) is necessary to prevent chelation and reduced bioavailability.
Sterility (for injectable forms):
Manufacturing sterile injectable LEVOFLOXACIN requires aseptic techniques or terminal sterilization, which demands high-grade cleanroom conditions and validation.

Q15. What are the storage conditions for LEVOFLOXACIN HEMIHYDRATE manufactured by Swapnroop Drugs & Pharmaceuticals?

Recommended storage conditions:

Temperature: Store at 25°C (77°F); excursions permitted to 15–30°C as per USP controlled room temperature guidelines.
Humidity: Protect from excessive moisture. Keep in a tightly closed container with desiccant if required.
Light protection: LEVOFLOXACIN is sensitive to light; store in light-resistant packaging or containers.
Packaging: Use HDPE bottles or aluminum blisters with low moisture permeability.
Labeling requirement: “Store in a cool, dry place. Protect from light and moisture” should be indicated.

Failure to store under recommended conditions can result in degradation, affecting potency and shelf life.

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