"Regulatory Packaging and Compliance Overview of LEVOMEPROMAZINE MALEATE LEVOMEPROMAZINE MALEATE manufactured by Swapnroop Drugs & Pharmaceuticals "

 


Q1: What is LEVOMEPROMAZINE MALEATE manufactured by Swapnroop Drugs & Pharmaceuticals?

LEVOMEPROMAZINE MALEATE is a phenothiazine derivative produced by Swapnroop Drugs & Pharmaceuticals and is primarily used as a typical antipsychotic and sedative medication. It is the maleate salt form of levomepromazine, which enhances its stability and solubility for pharmaceutical use.

🔍 Detailed Description:

🧬 Chemical Identity:

  • Generic Name: Levomepromazine Maleate

  • Chemical Formula: C₁₈H₂₄N₂S · C₄H₄O₄

  • Molecular Weight: ~460.6 g/mol (salt form)

  • Drug Class: Phenothiazine-class antipsychotic

  • CAS Number: 15687-18-0

💊 Key Features:

  • Dual Action: Acts both as an antipsychotic and a sedative/analgesic.

  • Formulation Type: Typically found in tablet or injectable forms.

  • Color/Appearance: White to off-white crystalline powder.

🧠 Mechanism of Action:

Levomepromazine primarily works by blocking dopamine (D2) receptors in the brain, which helps reduce psychotic symptoms such as hallucinations and delusions. It also has antihistaminic, anticholinergic, and alpha-adrenergic blocking effects, making it effective for:

  • Sedation 😴

  • Pain relief 😖➡️🙂

  • Treatment of severe agitation or psychosis 🧠💥

🏭 Why Swapnroop Drugs & Pharmaceuticals?

Swapnroop Drugs & Pharmaceuticals is known for producing high-quality Active Pharmaceutical Ingredients (APIs). Their manufacturing standards typically adhere to GMP (Good Manufacturing Practices), ensuring purity, efficacy, and compliance with pharmacopoeial standards like IP/USP/EP.

✅ Common Uses:

  • Schizophrenia and other psychotic disorders

  • Palliative care (for terminal agitation and pain)

  • Severe anxiety or insomnia

  • As a pre-anesthetic agent (in some settings




❓ Q2: What is LEVOMEPROMAZINE MALEATE by Swapnroop Drugs and Pharmaceuticals used for?

LEVOMEPROMAZINE MALEATE is a multifunctional drug used for its antipsychotic, sedative, antiemetic, and analgesic properties. It’s especially favored in settings where sedation and control of agitation or pain are important.

🩺 Primary Medical Uses:

  1. 🧠 Schizophrenia & Psychosis

    • Used to treat positive symptoms like hallucinations, delusions, and aggression.

  2. 😴 Sedation in Agitated Patients

    • Acts as a major tranquilizer, especially in psychiatric and emergency settings.

  3. ⚰️ Palliative Care

    • Commonly used to manage restlessness, pain, nausea, and terminal agitation in terminally ill patients.

  4. 🤢 Antiemetic Use

    • Effective against nausea and vomiting, including in chemotherapy or end-of-life care.

  5. 🛏️ Pre-anesthetic Medication

    • Helps calm patients before surgery and enhances the effects of anesthetics.

🌍 Off-Label Uses (Doctor-Supervised):

  • Severe anxiety where other drugs are not effective

  • Insomnia, especially in psychotic or terminally ill patients

  • Neuropathic pain, especially when other analgesics fail

🧪 Why It's Valued:

  • Broad receptor activity: Hits dopamine, histamine, and serotonin receptors.

  • Long-acting: Provides extended control of symptoms, especially when used in injectable form.

  • Works well when others don’t: Often used when patients are resistant to other treatments.

🔬 Q3: What are the physicochemical properties of LEVOMEPROMAZINE MALEATE manufactured by Swapnroop Drugs and Pharmaceuticals?

Understanding the physicochemical properties of a drug helps determine its formulation, bioavailability, stability, and method of delivery. Here's a detailed breakdown of LEVOMEPROMAZINE MALEATE:

⚛️ Basic Properties:

  • Molecular Formula: C₁₈H₂₄N₂S · C₄H₄O₄

  • Molecular Weight: ~460.6 g/mol

  • Appearance: White to off-white crystalline powder

  • Odor: Odorless

  • Taste: Bitter

💧 Solubility:

  • Freely soluble in water 💦

  • Soluble in ethanol and methanol

  • Insoluble in chloroform and ether

📏 Other Physicochemical Characteristics:

  • Melting Point: Approx. 185–190°C

  • pKa: ~9.2 (basic, due to nitrogen atoms in the side chain)

  • Partition Coefficient (LogP): Moderate (supports CNS penetration)

  • Hygroscopicity: Non-hygroscopic to slightly hygroscopic

🧬 Stability:

  • Stable under dry, cool, dark conditions

  • Sensitive to light and moisture in solution form — hence often stored in amber containers

  • Stable in pH range 4–7

💊 Impact on Formulation:

These physicochemical properties affect:

  • Formulation type (e.g., injectable vs. tablet)

  • Bioavailability (good CNS penetration due to moderate lipophilicity)

  • Shelf-life (stability over time with proper storage)



Q4: How is LEVOMEPROMAZINE MALEATE manufactured by Swapnroop Drugs and Pharmaceuticals synthesized?

LEVOMEPROMAZINE MALEATE is synthesized via a multi-step organic process starting from phenothiazine derivatives. The synthesis involves functional group transformations and salt formation to enhance pharmaceutical properties.

🧬 General Synthesis Route (Simplified):

  1. Synthesis of Phenothiazine Core 🧱

    • The core structure is built from diphenylamine and sulfur through oxidative cyclization to form phenothiazine, the base structure for many antipsychotics.

  2. Side Chain Introduction 🧪

    • A 3-chloropropylamine derivative is attached at the 10-position of the phenothiazine ring through nucleophilic substitution, forming 10-(3-dimethylaminopropyl)phenothiazine.

  3. Chiral Resolution (Optional) 🧬

    • Levomepromazine is the levorotatory isomer of methotrimeprazine, which may require optical resolution to isolate the active enantiomer.

  4. Maleate Salt Formation 🧂

    • The free base is reacted with maleic acid in ethanol or acetone to form levomepromazine maleate, which increases water solubility and stability.

🧼 Purification & Crystallization:

  • Recrystallized from ethanol–water or methanol–ether

  • Dried under vacuum to remove solvent traces

  • Controlled particle size achieved by micronization

🏭 Manufacturing Notes (Swapnroop):

  • Likely produced under GMP-compliant conditions

  • Followed by HPLC and FTIR testing to confirm identity and purity

  • Ensures enantiomeric purity if applicable

💊 Q5: What are the different dosage forms of LEVOMEPROMAZINE MALEATE manufactured by Swapnroop Drugs and Pharmaceuticals?

LEVOMEPROMAZINE MALEATE is available in various dosage forms tailored to clinical needs—ranging from rapid sedation to long-term oral therapy.

🔹 1. Oral Tablets / Film-coated Tablets

  • Most common form

  • Available in strengths like 25 mg, 50 mg, and 100 mg

  • Used for chronic psychiatric conditions or sedation

🔹 2. Injectable Solution (Intramuscular or Intravenous) 💉

  • Used for acute agitation, pain, or end-of-life care

  • Fast onset of action

  • Available in ampoules (e.g., 25 mg/mL, 50 mg/mL)

🔹 3. Oral Syrup / Solution (less common)

  • Easier to administer to pediatric or elderly patients

  • Suitable for dose titration

🔹 4. Suppositories (in some markets)

  • Rectal administration for patients unable to swallow

  • Used in palliative care

🧴 Formulation Characteristics:

  • Tablet Excipients: Lactose, magnesium stearate, starch, PVP

  • Injectable Form: Buffered aqueous solution, pH adjusted to 5.5–6.5

  • Packaging: Tablets in blister packs or HDPE bottles; injectables in amber ampoules


🏗️ Q6: How are LEVOMEPROMAZINE MALEATE dosage forms prepared by Swapnroop Drugs and Pharmaceuticals?

The preparation of LEVOMEPROMAZINE MALEATE dosage forms involves pharmaceutical formulation science that ensures stability, bioavailability, and patient compliance. Below is an overview of the preparation processes for different dosage forms:

💊 1. Tablet Preparation (Oral)

Process:

  • Step 1: Weighing and blending of API with excipients like lactose, microcrystalline cellulose, and starch.

  • Step 2: Wet granulation (using PVP solution) or dry granulation to form uniform granules.

  • Step 3: Drying in fluidized bed dryer or tray dryer.

  • Step 4: Milling/sieving to achieve uniform particle size.

  • Step 5: Blending with lubricants (e.g., magnesium stearate).

  • Step 6: Compression into tablets using rotary tablet press.

  • Step 7: Optional film-coating for taste masking or stability.

  • Step 8: Packing in blisters or HDPE containers.

✅ Critical Controls:

  • Uniformity of weight

  • Disintegration time

  • Tablet hardness and friability

  • Assay and dissolution rate

💉 2. Injectable Solution (IM/IV)

Process:

  • Step 1: Dissolve LEVOMEPROMAZINE MALEATE in sterile water for injection.

  • Step 2: Adjust pH (typically 5.5–6.5) using sodium acetate or hydrochloric acid.

  • Step 3: Filter through 0.22-micron sterile filters.

  • Step 4: Fill aseptically into amber glass ampoules or vials.

  • Step 5: Terminal sterilization via autoclaving or aseptic fill finish.

  • Step 6: Visual inspection and labeling.

✅ Critical Controls:

  • Sterility

  • Particulate matter

  • Assay and pH

  • Clarity and color

🧪 3. Syrup / Oral Solution

Process:

  • API is dissolved or suspended in water with sweeteners (e.g., sorbitol), flavors, and preservatives.

  • Homogenization ensures uniform distribution.

  • pH is adjusted for stability (acidic range).

  • Filled into amber PET bottles.

🧴 4. Suppository (less common)

  • Levomepromazine is dispersed in fatty base like cocoa butter or polyethylene glycol.

  • Molten mixture poured into molds and allowed to solidify.

✅ Q7: What is the appropriate dosage form of LEVOMEPROMAZINE MALEATE manufactured by Swapnroop Drugs and Pharmaceuticals?

The appropriate dosage form of LEVOMEPROMAZINE MALEATE depends on the patient's condition, urgency of treatment, and route of administration needed. Swapnroop likely manufactures the most clinically relevant forms based on standard therapeutic use.

📌 Selection by Clinical Use:

ConditionAppropriate Dosage FormWhy?
🧠 Chronic Psychosis / SchizophreniaTablets (25–100 mg)Oral route is preferred for long-term maintenance.
⚠️ Acute Agitation / DeliriumInjectable (IM or IV)Rapid onset; suitable for uncooperative or unconscious patients.
⚰️ Palliative Care / Terminal IllnessInjection or Oral SolutionFlexibility in administration; used for pain, agitation, and nausea.
😴 Preoperative SedationInjection or TabletsFast effect required before anesthesia.
👶 Pediatric or swallowing difficultyOral syrup (if available)Easier administration in special populations.

🔄 Other Factors Influencing Form:

  • Onset of action required

  • Patient’s ability to swallow or tolerate oral meds

  • Need for precise dosing or titration

  • Stability and shelf-life considerations

Q8: When should LEVOMEPROMAZINE MALEATE API manufactured by Swapnroop Drugs and Pharmaceuticals be taken?

The timing of administration for LEVOMEPROMAZINE MALEATE depends heavily on the indication, formulation, and patient response. Since it is a sedating antipsychotic, proper timing enhances therapeutic benefit while minimizing disruption to daily functioning.

🧠 For Psychosis or Schizophrenia (Maintenance):

  • 📅 Frequency: Typically 2–3 times daily, depending on dose and patient tolerance.

  • 🌙 Preferred timing: At bedtime or late evening, due to its strong sedative effect.

  • ⏳ Onset: Oral forms act in 1–2 hours; IM injections are faster (~30 mins).

🆘 For Acute Agitation / Emergency Sedation:

  • Administered as needed (PRN) via IM or IV injection under medical supervision.

  • Can be repeated at intervals (e.g., every 4–6 hours) based on clinical response.

  • 🛌 Best used in controlled settings like psychiatric units or palliative care wards.

🤢 For Antiemetic Use:

  • Administered 30–60 minutes before meals or chemotherapy/radiation.

  • Used in conjunction with other antiemetics when needed.

⚰️ In Palliative Care:

  • Often given around the clock (every 6–8 hours) or continuously via syringe driver to manage agitation, pain, and nausea.

  • Timing is individualized based on symptom burden and comfort goals.

❗ Clinical Note:

  • 🚫 Avoid daytime use in ambulatory patients unless sedation is intended.

  • 📛 Risk of daytime drowsiness, dizziness, and orthostatic hypotension if taken inappropriately.

💥 Q9: What are the effects and side effects of LEVOMEPROMAZINE MALEATE manufactured by Swapnroop Drugs and Pharmaceuticals?

LEVOMEPROMAZINE MALEATE has a broad pharmacological profile, which allows for multiple therapeutic effects, but also brings the potential for side effects, especially with long-term or high-dose use.

✅ Therapeutic Effects (Desired):

  1. Antipsychotic – reduces hallucinations, delusions, aggression 🧠🧊

  2. Sedative – induces calm and sleep 😴

  3. Analgesic – mild to moderate pain relief ⚡➡️🙂

  4. Antiemetic – suppresses nausea and vomiting 🤢🛑

  5. Anxiolytic – reduces anxiety in certain conditions 😟➡️🙂

⚠️ Common Side Effects:

SystemSide Effects🔎 Notes
🧠 CNSDrowsiness, dizziness, confusion, extrapyramidal symptoms (EPS)EPS: tremor, rigidity, akathisia
💓 CardiovascularHypotension, tachycardiaMonitor BP
🫁 RespiratoryDepression at high dosesIn overdose or frail patients
🍽️ GIDry mouth, constipationDue to anticholinergic activity
🌡️ EndocrineHyperprolactinemia, weight gainEspecially with long-term use
🧴 SkinRash, photosensitivityRare but notable
🩸 HematologicalRarely agranulocytosis or leukopeniaRequires monitoring

🔺 Serious (but rare) Adverse Reactions:

  • Neuroleptic Malignant Syndrome (NMS): A rare but life-threatening condition with fever, muscle rigidity, and altered consciousness 🚨

  • QT prolongation / cardiac arrhythmias: Caution in patients with heart disease

  • Seizures: Risk in predisposed individuals

🧪 Monitoring Parameters:

  • Liver and renal function

  • Blood pressure

  • Extrapyramidal symptoms

  • ECG (in prolonged or high-dose therapy)


Q10: How is LEVOMEPROMAZINE MALEATE manufactured by Swapnroop Drugs and Pharmaceuticals tested?

LEVOMEPROMAZINE MALEATE undergoes strict quality control and quality assurance tests during and after manufacturing to ensure that it meets the standards of pharmacopeias like USP, IP, or EP.

Swapnroop Drugs & Pharmaceuticals likely follows GMP (Good Manufacturing Practices) and uses validated analytical methods to test both API (Active Pharmaceutical Ingredient) and finished dosage forms.

🧫 Key Testing Stages:

  1. ✅ Raw Material Testing

    • Identity, purity, and microbial limits of all excipients and solvents are tested before manufacturing begins.

  2. 🔬 In-Process Controls (IPQC)

    • Granule particle size

    • Blend uniformity

    • pH and clarity of solution (for injectables)

    • Compression weight and hardness (for tablets)

  3. 📦 Finished Product Testing

    • Identity confirmation (via FTIR, UV, or HPLC)

    • Assay for content uniformity and potency

    • Dissolution (for tablets) or sterility (for injections)

    • Microbial limits, endotoxins

    • pH, osmolality (in solutions)

    • Stability studies

🔄 Stability Testing (ICH Guidelines):

  • Conducted under various temperature/humidity conditions:

    • Long-term (25°C/60% RH)

    • Accelerated (40°C/75% RH)

    • For shelf-life prediction and packaging validation

🧾 Q11: What tests are performed on LEVOMEPROMAZINE MALEATE manufactured by Swapnroop Drugs and Pharmaceuticals?

The following pharmacopoeial and non-pharmacopoeial tests are typically performed on LEVOMEPROMAZINE MALEATE to ensure identity, strength, quality, purity, and safety:

📋 1. Identification Tests

  • UV-Vis spectroscopy

  • Fourier-transform infrared spectroscopy (FTIR)

  • High-performance liquid chromatography (HPLC)
    ✅ Confirms chemical structure and identity of API.

⚖️ 2. Assay (Potency)

  • HPLC or UV-Spectroscopy-based method
    ✅ Ensures API content is within pharmacopeial range (e.g., 98–102%).

⏱️ 3. Dissolution Test (Tablets)

  • Uses USP Apparatus II (paddle method)

  • Measures how quickly the drug releases in simulated gastric fluid
    ✅ Ensures consistent bioavailability.

💉 4. Sterility and Pyrogen Tests (Injectables)

  • Sterility test: Confirms absence of microbial contamination

  • Bacterial endotoxin test: (LAL Test) checks for pyrogens
    ✅ Ensures safe IV/IM administration

⚠️ 5. Related Substances / Impurity Profile

  • Performed by HPLC with suitable reference standards
    ✅ Ensures that degradation products or process impurities are below acceptable limits.

🧪 6. pH and Osmolality

  • For injectable or oral solutions
    ✅ Confirms physiological compatibility

🧫 7. Microbial Limit Tests

  • For non-sterile forms (e.g., tablets, syrups)
    ✅ Checks for total aerobic count, molds, and absence of pathogens like E. coli or Salmonella.

📉 8. Stability & Shelf-Life Studies

  • Accelerated and real-time testing under ICH conditions
    ✅ Used to establish expiration date and storage conditions.



Q12: What are the challenges in manufacturing LEVOMEPROMAZINE MALEATE API by Swapnroop Drugs & Pharmaceuticals?

Manufacturing the active pharmaceutical ingredient (API) of LEVOMEPROMAZINE MALEATE involves multiple synthetic, purification, and quality control steps. Each of these presents specific technical and regulatory challenges.

⚗️ 1. Complex Multi-step Synthesis

  • The synthesis of levomepromazine involves a multi-step chemical pathway including:

    • Phenothiazine core synthesis

    • Side chain alkylation

    • Salt formation with maleic acid

  • Each step requires strict control over temperature, reaction time, and pH.

🧬 2. Chiral Purity / Isomer Separation

  • Levomepromazine is the levo-isomer of methotrimeprazine.

  • Ensuring enantiomeric purity (optical isomer separation) is challenging and may require chiral resolution techniques, which are expensive and yield-limiting.

⚠️ 3. Impurity Control

  • The phenothiazine structure is prone to oxidation and degradation, producing colored or toxic impurities.

  • Ensuring compliance with ICH Q3A/B impurity limits is essential for regulatory approval.

💧 4. Solubility and Crystallization Issues

  • Achieving consistent crystal morphology and particle size distribution (PSD) during salt formation with maleic acid can be difficult.

  • Poor control can affect flow properties and compressibility.

🧪 5. Analytical Method Development

  • High-precision techniques like HPLC, NMR, and FTIR are required to:

    • Confirm structure

    • Quantify residual solvents

    • Ensure purity

  • Development and validation of these methods is resource-intensive.

📜 6. Regulatory Compliance

  • Swapnroop must comply with international regulatory filings such as DMFs (Drug Master Files), CEP (Certificate of Suitability), or USFDA submissions.

  • This includes full process validation, stability data, and impurity profiling.

💊 Q13: What are the challenges in manufacturing LEVOMEPROMAZINE MALEATE dosage forms by Swapnroop Drugs & Pharmaceuticals?

Converting LEVOMEPROMAZINE MALEATE API into finished pharmaceutical dosage forms (e.g., tablets, injectables) involves formulation, stability, and bioavailability challenges.

💊 1. Dose Uniformity in Tablets

  • The drug is used at relatively low to moderate doses (e.g., 25–100 mg), so ensuring content uniformity across tablets, especially in low-dose batches, is critical.

  • Requires precise blending and granulation control.

💦 2. Hygroscopicity / Stability Issues

  • Levomepromazine maleate can be slightly hygroscopic and photosensitive, especially in solution.

  • This necessitates use of desiccants, amber packaging, and controlled environments.

🧪 3. Solubility and Bioavailability

  • While the maleate salt improves solubility, formulation pH must be optimized to maintain solubility and stability.

  • Oral formulations require careful selection of excipients to ensure release and absorption.

💉 4. Injectable Formulation Challenges

  • Sterile injectables need:

    • pH control (5.5–6.5)

    • Particulate-free solutions

    • A non-irritating formulation

  • Must meet stringent sterility and endotoxin standards, making it more complex and expensive.

🧫 5. Microbial and Preservation Risks

  • Oral solutions or syrups, if manufactured, must include effective preservatives to pass microbial limits testing.

  • Risk of fungal or bacterial contamination if not properly formulated.

🧴 6. Packaging & Stability

  • Sensitive to light, air, and moisture, particularly in liquid form.

  • Requires airtight amber containers and stability testing across multiple conditions.

📉 7. Shelf-life Determination

  • The product must retain at least 90% potency throughout shelf life.

  • Requires extensive accelerated and real-time stability studies (ICH guidelines).

Q14: What are the recommended storage conditions for LEVOMEPROMAZINE MALEATE API and its dosage forms?

Proper storage ensures the stability, potency, and compliance with pharmacopeial and regulatory standards.

🔹 API (Active Pharmaceutical Ingredient)

  • Temperature:
    Store below 25°C (may also be labeled as “room temperature”).
    Avoid excessive heat (≥30°C), which can lead to degradation.

  • Humidity:
    Maintain <60% relative humidity. Store in a dry area.
    LEVOMEPROMAZINE MALEATE is slightly hygroscopic, so moisture protection is critical.

  • Light protection:
    Protect from light. The phenothiazine structure is photosensitive and degrades under UV exposure.

  • Container:

    • Use airtight, light-resistant containers (e.g., amber glass or HDPE containers).

    • Inert gas blanketing (e.g., nitrogen) may be recommended for long-term storage.

  • Labeling:
    Include “Store in a tightly closed container, protected from light and moisture”.

🔸 Finished Dosage Forms (e.g., tablets, oral solution, injection)

Dosage FormStorage TempOther Conditions
Tablets15–25°CProtect from moisture and light
Oral solution2–8°C or 15–25°CRefrigerate if aqueous; avoid freezing
Injectables2–8°CProtect from light; do not freeze

Stability studies must be done under ICH guidelines (Q1A) to justify shelf life and labeling.

📦 Q15: What is the appropriate packaging system for LEVOMEPROMAZINE MALEATE API and its dosage forms?

Packaging must ensure chemical stability, moisture protection, and light shielding, especially for phenothiazines like levomepromazine.

🔹 API Packaging (Bulk)

  • Primary packaging:

    • Double polyethylene bags inside fiberboard or HDPE drums (with tamper-evident seals).

    • Light-resistant (amber) and airtight.

  • Secondary packaging (export):

    • Use corrugated fiberboard boxes with insulation and moisture barrier liners.

    • Include desiccants and humidity indicators inside the drum, if required.

  • Labeling includes:

    • Batch number, Mfg/Exp dates, net weight, storage instructions, handling precautions, and manufacturer details.

🔸 Dosage Form Packaging

Dosage FormPackaging TypeProtection Features
TabletsBlister (PVC/Alu or Alu-Alu), HDPE bottlesMoisture, light, mechanical protection
Oral solutionAmber PET/glass bottle with child-resistant capLight and microbial contamination protection
InjectablesAmber glass vials/ampoules with flip-off sealsSterility, light protection, tamper-evidence

  • Blister vs Alu-Alu:

    • PVC-Alu is cost-effective but offers less barrier protection.

    • Alu-Alu preferred for humid climates due to superior moisture barrier.

  • Vial labeling includes:

    • Concentration, route (IM/IV), storage, warnings, batch details, and expiry.


🌍 Q16: What regulatory filings (like USDMF, EDMF, CEP) exist for LEVOMEPROMAZINE MALEATE API?

As of now, the following regulatory filing types may be applicable for LEVOMEPROMAZINE MALEATE. Specific filings by Swapnroop Drugs & Pharmaceuticals would need to be verified from regulatory databases such as US FDA’s DMF database, EDQM’s CEP listing, or Health Canada.

🔹 Common Filings for LEVOMEPROMAZINE MALEATE API

Filing TypeDescriptionAvailability for Levomepromazine Maleate
USDMFDrug Master File with the USFDA (Type II)✅ Available (by other manufacturers)
EDMFEuropean Drug Master File✅ Possible; not always publicly listed
CEPCertificate of Suitability by EDQM (Europe)✅ Issued to some European manufacturers
ASMFActive Substance Master File (EU equivalent of DMF)✅ Used in EU filings
J-DMFJapanese Drug Master File❓ Rare; usually filed by Japanese manufacturers
CADIFABrazilian DMF✅ Required if registering in Brazil

🔸 Swapnroop Drugs & Pharmaceuticals

  • You will need to confirm directly whether Swapnroop has filed a:

    • USDMF with an assigned number

    • CEP through EDQM

    • Or an EDMF/ASMF for European regulatory submissions

🧾 You can request a Letter of Access (LOA) for these filings when a finished formulation partner files their regulatory dossier (ANDA, MA, etc.).



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